The PEDS Rest Study: Restless Legs Syndrome

7/30/2019 The PEDS Rest Study: Restless Legs Syndrome

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DOI: 10.1542/peds.2006-27672007;120;253Pediatrics

Myers and Luigi Ferini-StrambiDaniel Picchietti, Richard P. Allen, Arthur S. Walters, Julie E. Davidson, Andrew

The Peds REST StudyRestless Legs Syndrome: Prevalence and Impact in Children and Adolescents

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ARTICLE

Restless Legs Syndrome: Prevalence and Impact inChildren and AdolescentsThe Peds REST Study

Daniel Picchietti, MDa, Richard P. Allen,PhDb, Arthur S.Walters,MDc, Julie E. Davidson, MPHd, AndrewMyers,PhDe, LuigiFerini-Strambi,MDf

aUniversity of Illinois and Carle Clinic Association, Urbana, Illinois; bDepartment of Neurology, Johns Hopkins University, Baltimore, Maryland; cSeton Hall University

School of Graduate Medical Education and New Jersey Neuroscience Institute at JFK Medical Center, Edison, New Jersey; dWorldwide Epidemiology, GlaxoSmithKline

R&D, Harlow, United Kingdom; ePremark Services, Crawley Down, United Kingdom; fSleep Disorders Center, Universita Vita-Salute and IRCCS H San Raffaele, Milan, Italy

Financial Disclosure: This project was su pported by GlaxoSmithKline Research and Development. Dr Picchietti receives grant support from the Carle Foundation.

ABSTRACT

OBJECTIVES. Restless legs syndrome, a common neurologic sleep disorder, occurs in

5% to 10% of adults in the United States and Western Europe. Although 25%

of adults with restless legs syndrome report onset of symptoms between the ages

of 10 and 20 years, there is very little literature looking directly at the prevalence

in children and adolescents. In this first population-based study to use specific

pediatric diagnostic criteria, we examined the prevalence and impact of restless

legs syndrome in 2 age groups: 8 to 11 and 12 to 17 years.METHODS. Initially blinded to survey topic, families were recruited from a large,

volunteer research panel in the United Kingdom and United States. Administra-

tion was via the Internet, and results were stratified by age and gender. National

Institutes of Health pediatric restless legs syndrome diagnostic criteria (2003) were

used, and questions were specifically constructed to exclude positional discomfort,

leg cramps, arthralgias, and sore muscles being counted as restless legs syndrome.

RESULTS. Data were collected from 10 523 families. Criteria for definite restless legs

syndrome were met by 1.9% of 8- to 11-year-olds and 2.0% of 12- to 17-year-

olds. Moderately or severely distressing restless legs syndrome symptoms were

reported to occur 2 times per week in 0.5% and 1.0% of children, respectively.

Convincing descriptions of restless legs syndrome symptoms were provided. No

significant gender differences were found. At least 1 biological parent reported

having restless legs syndrome symptoms in 70% of the families, with both

parents affected in 16% of the families. Sleep disturbance was significantly more

common in children and adolescents with restless legs syndrome than in controls

(69.4% vs 39.6%), as was a history of growing pains (80.6% vs 63.2%). Various

consequences were attributed to restless legs syndrome, including 49.5% endors-

ing a negative effect on mood. Data were also collected on comorbid conditions

and restless legs diagnosis rates.

CONCLUSIONS. These population-based data suggest that restless legs syndrome is

prevalent and troublesome in children and adolescents, occurring more commonly

than epilepsy or diabetes.

www.pediatrics.org/cgi/doi/10.1542/

peds.2006-2767

doi:10.1542/peds.2006-2767

This study was presented at the SLEEP

2006 meeting; June 1722, 2006; Salt Lake

City, UT.

KeyWords

restless legs syndrome, prevalence, sleep

disorder, growing pains, attention-deficit/

hyperactivity disorder, depression, anxiety,

children, adolescents

Abbreviations

RLSrestless legs syndrome

NIHNational Institutes of Health

ADHDattention-deficit/hyperactivity

disorder

Accepted for publication Apr 3, 2007

Address correspondence to Daniel Picchietti,

MD, University of Illinois School of Medicine

and Carle Clinic Association, Department of

Pediatrics, 602 W University Ave, Urbana, IL

61801. E-mail: [email protected]

PEDIATRICS (ISSNNumbers:Print, 0031-4005;

Online, 1098-4275). Copyright 2007by the

AmericanAcademy of Pediatrics

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RESTLESS LEGS SYNDROME (RLS) is a common neuro-logic sleep disorder in adults characterized by thefollowing diagnostic criteria: an urge to move that is

usually associated with unpleasant sensations, and

symptoms that are worse at rest, relieved by movement,

and most severe at night.1,2 Population-based studies in

adults using these 4 essential diagnostic criteria for RLS

found a prevalence of 5% to 10% in the United Statesand Western Europe.39 In 2 studies, the prevalence of

moderately to severely affected adults, with 2 to 3 days

per week or more of symptoms and a significant impact

on the quality of life, was 2.5%.3,10 Less extensive

studies have found lower prevalence in Asian popula-

tions1113 and in India.14,15 The impact of RLS can be quite

severe, with significant adverse effects in adults on

sleep,16 cognitive function,17,18 mood,19 and quality of

life.3,20 Nonetheless, the condition continues to be signif-

icantly underdiagnosed.10,21

Although Ekbom22,23 reported RLS symptomatology

in childhood as early as the 1940s, it was not until themid-1990s that detailed pediatric case reports with poly-

somnography appeared in the literature.24,25 Other case

reports and case series have followed.2635 Consensus

criteria for the diagnosis of RLS in children and adoles-

cents were published in 2003 after a workshop at the

National Institutes of Health (NIH)2 and are summarized

in Fig 1. The pediatric criteria evolved out of the adults

RLS criteria and 2 previous versions of pediatric crite-

ria.25,36 Two major concepts were incorporated, more

difficult to achieve criteria than in adults for a definitive

diagnosis in children and separate research categories for

less definitive cases. The first was agreed on to avoidoverdiagnosis in children and the second to try and

capture a broader spectrum of RLS in childhood for

research purposes. On the basis of clinical experience

and the development of better language skills in adoles-

cents than in young children, the NIH committee de-

cided to use the adult criteria for adolescents, although

the categories of probable and possible RLS were left

open as an option for research. These new pediatric RLS

criteria were subsequently included in the International

Classification of Sleep Disorders Diagnostic Manual (second

edition).37 Work on pediatric RLS in the past 12 years has

emphasized the familial occurrence of RLS, the associa-

tion with periodic limb movements in sleep, and the

relationship to attention-deficit/hyperactivity disorder

(ADHD) in some cases.38

Studies have indicated that many adults with RLS

retrospectively recall that their symptoms started in

childhood or adolescence. Two such reports noted onset

of RLS for 25% in the 10- to 20-year-old age range.39,40

A pediatric RLS prevalence of 5.9% was found at the

Mayo Clinic pediatric sleep disorders clinic,27 and an-

other study found a prevalence of 1.3% in 12 pediatric

practices.41 In addition, a study that included a question

about leg restlessness at bedtime found this in 6.1% of

Canadian children 11 to 13 years old.42 However, no

published studies have used the essential adult criteria or

the pediatric consensus criteria to assess the prevalence

of RLS in children and adolescents in the general popu-

lation.

The aims of the Peds RLS Epidemiology, Symptoms,

and Treatment (Peds REST) study were to characterize

the epidemiology of pediatric RLS in 2 general popula-tions, in the United Kingdom and United States, as well

as collect data on symptoms, severity, family history,

impact, diagnosis rates, treatments, and comorbidities.

METHODS

Study Population

A random selection of households identified from a

large, volunteer market-research panel in the United

Kingdom and United States were invited to participate in

this survey. Respondents were blinded to the content of

the survey before accepting the invitation, and only 1

survey was permitted per household. Those enrolled

into the survey were households with 1 child in the

eligible age range (817 years inclusive), where the

eligible child was the biological child of the responding

adult and where informed consent was given. When1

child was eligible in a household, the survey child was

selected randomly by using the last-birthday method.43

Figure 2 depicts the selection and enrollment process.

The volunteer market-research panel consisted of

163 000 respondents in the United Kingdom and

128 000 in the United States. Members were originally

enrolled into the panel through an online invitation and

agreed to participate in surveys on a variety of topics

such as leisure, consumer products, and health. Respon-

dents were paid a sum equivalent to approximately $12

or 10 Euros for completing each survey.

Survey Design

The survey consisted of questions about RLS symptoms,

the impact of symptoms on sleep and daytime function,

treatment-seeking behavior, diagnoses, treatments re-

ceived, comorbidities, and family history of RLS (Table

1). The survey consisted of 4 sections with the last 2

sections containing detailed questions for those who

responded positively to earlier questions indicative of

RLS. We stratified by age into 2 groups: 8 through 11

years, inclusive, and 12 through 17 years, inclusive. This

follows US Food and Drug Administration age group-

ings, which are slightly different from NIH age groupings

that have a break point at 13 years rather than 12 years.

In the complete survey, there were 48 total questions

about the 8- to 11-year-olds and 49 about the 12- to

17-year-olds. The surveys were field tested by 6 families,

each with a child or adolescent patient known to have

RLS by expert evaluation. Half were in the younger age

group and half in the older group. The surveys were

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FIGURE 1

NIH Workshop diagnostic criteria for RLS in children (2003). PLMS indicates periodic limb movements in sleep.



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found to perform well in this sample. Where the eligible

child was age 8 to 11 years old, the responding parent

was asked to complete the survey with the child present

for the section that contained questions about leg sen-

sations. Where the eligible child was age 12 to 17, the

sections referring to symptoms experienced, distress, and

consequences were completed by the adolescent. The

survey was administered online and respondents were

routed automatically to relevant questions on the basis

of their responses. The research was conducted from

April 11 to 25, 2005.

RLSCase Definition

On the basis of the pediatric NIH criteria2 (Fig 1), a

survey response-based algorithm for definite and prob-

able RLS, appropriate to each of the 2 age groups, was

developed by an expert panel (Drs Picchietti, Allen,

Walters, and Ferini-Strambi). Case status was evaluated

sequentially, with respondents being assessed first for

definite RLS and then for probable RLS. Where verbatim

descriptors were used in the RLS definitions, the descrip-

tors were reviewed by 3 experts (Drs Picchietti, Allen,

and Walters) in a blinded fashion. The focus of this

article is definite RLS. Although extensive data for prob-

able RLS were collected, probable RLS was only included

in the prevalence analysis, and there as a separate table.

Additional work is planned to assess the role of probable

RLS in the pediatric diagnostic scheme. Moderate-to-

severe RLS was defined as RLS with symptom frequency

of at least twice per week and at least moderate distress

reported (on a 4-point scale: extremely, moderately, a

little, or not at all).

FIGURE 2

Entry of participants into the study.



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There were specific survey questions to exclude sim-

ple positional discomfort, leg cramps, arthralgias, and

sore muscles from being counted as RLS.

Analysis

Analysis was conducted by using the Statistical Package

for the Social Sciences software (SPSS, Inc, Chicago, IL).

When appropriate, differences between groups were

tested by using descriptive tests (eg, 2 test statistic,

Students t statistic) and confidence intervals.

RESULTS

Survey Population

Entry of participants into the study is depicted in Fig 2.

Of 266 686 households invited to participate, 38 548responded in the time frame needed to obtain an ade-

quate sample size. Of those, 12 874 families had a child

in the valid age range, 11 815 consented to participate,

and 11 582 were eligible on the basis of the requirement

that a biological parent complete the survey. A total of

10 523 completed the detailed survey. Thus, 4% of the

total pool was sampled, and of those meeting all eligi-

bility screens, 91% completed the survey. Of the 10 523

children and adolescents, there were 2133 girls and 2192

boys in the 8- to 11-year age range, and in the 12- to

17-year age range there were 2981 girls and 3217 boys.

Of 4325 participants in the 8- to 11-year age range,2092 were from the United Kingdom and 2233 from the

United States. Of 6198 participants in the 12- to 17-year

age range, 2707 were from the United Kingdom and

3491 from the United States. Because prevalence rates

were not significantly different between the United

Kingdom and the United States, data were combined in

each age range for analysis, except for comorbidity data,

which did show significantly different rates of comorbid

diagnoses between countries.

Prevalence of RLSSymptoms

A total of 206 children and adolescents met the diag-

nostic criteria for definite RLS (Table 2). This corre-

sponds with a prevalence of 1.9% for ages 8 to 11

years and 2.0% for ages 12 to 17 years. Of these, 27%

(22 of 81) and 52% (65 of 125), respectively, reported

moderate-to-severe RLS, corresponding with preva-

lence estimates of 0.5% and 1.0%. Criteria for prob-

able 1 RLS were met by an additional 0.7% of 8- to

11-year-olds and 0.3% of 12- to 17-years-olds (Table

3).

No significant gender differences were found in either

age group for definite or probable RLS. See Table 4 for a

TABLE 1 Questionnaire Summary

Section Questions Included

Eligibility screen Presence of child age18 y and childs birth date

Informed consent to participate

Is responding parent the biological parent?

Is child/adolescent currently present in person?

Household demographics

Primary RLS screen Has child or adolescent:

ever experienced uncomfortable feelings or sensations

in their legs and a strong urge to move the legs while

sitting or lying down?a

ever experienced growing painsa

experienced difficulty in falling asleep or staying asleep

at night?a

RLS characteristics Does child or adolescent have difficulties sitting or lying

still in the evening or night?a

Does leg movement seem to make the leg discomfort

better or worse?a

When do these uncomfortable feelings and the need to

move to relieve them seem worst?a

Are symptoms almost always caused by positional

discomfort or muscle cramp?a

Frequency of symptomsa

Parental history of RLS

Additional questions Time of day of symptomsa

Symptoms experienced (from list of 11)a

Most troublesome symptoms (from list of 11)a

Words the child has used to describe the symptoms

(children only)

Effect of symptoms including distress, impact on sleep,

activities, etca

History of medical diagnosis for . . . (from list of 17

conditions)

Age at onset of symptoms

Consulted a healthcare professional in previous 12

months for symptoms? Diagnosis received

Treatments taken

For age 8 to 11 years, all questions answered by biological parent with input from child.a For age 12 to 17 years, questions were answered by the adolescent directly and other ques-

tions answered by biological parent.

TABLE 2 Prevalence ofDefinite RLS: Ages 8 to 17Years

Age, y Survey

Participants

At Least Once per Month At Least 3 Times per

Month

At Least Twice per Week At Least Twice per Week

and Moderate-to-Severe

Distressa

n Prevalence

(95% CI)

n Prevalence

(95% CI)

n Prevalence

(95% CI)

n Prevalence

(95% CI)

811 4325 81 1.9% (1.52.3) 64 1.5% (1.11.8) 40 0.9% (0.61.2) 22 0.5% (0.30.7)

1217 6198 125 2.0% (1.72.4) 119 1.9% (1.62.3) 89 1.4% (1.11.7) 65 1.0% (0.81.3)

Total 10 523 206 2.0% (1.72.2) 183 1.7% (1.52.0) 129 1.2% (1.01.4) 87 0.8% (0.71.0)

CI indicates confidence interval.a Moderate-to-severe RLS.



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detailed analysis of gender data for the definite RLS

groups.

Parents of children 8 to 11 years reported the age at

which uncomfortable feelings in the legs first appeared

in their child as: 5 years old for 15%, 5 to 7 years old

for 63%, and 8 years old for 22%.

Symptoms Reported andPerceived Impactof RLS

Descriptions of RLS

For the children 8 to 11 years old, detailed descriptions

of the RLS feelings were obtained because in this age

range urge and a description in the childs own words,

consistent with leg discomfort are required for the def-

inite 1 category (Fig 1). Examples of the descriptions

provided by participants are in Table 5.

Growing Pains

Children and adolescents with definite RLS were signif-

icantly more likely to report experience of growing

pains compared with those who did not meet the cri-

teria for definite or probable RLS (overall 80.6% vs

63.2%; P .001). Table 6 lists percent with a history of

growing pains by age category.

Distress

When asked how distressing the RLS symptoms were

(extremely, moderately, a little, or not at all), 22.2% (18

of 81) of responding parents of the 81 children who met

definite RLS criteria reported that the symptoms were

extremely distressing to their children, 32.1% (26 of 81)

reported moderate distress, 39.5% (32 of 81) reported a

little distress, and 6.2% (5 of 81) stated the symptomswere not at all distressing. Adolescents meeting definite

RLS criteria (n 125) were asked directly about their

level of distress, and 23.2% (29 of 125) reported extreme

distress, 40.8% (51 of 125) moderate distress, 31.2% (39

of 125) a little distress, and 4.8% (6 of 125) no distress.

Respondents were asked to select from a list the RLS

symptoms that they experienced. See Fig 3A for the

proportions of respondents reporting each symptom. In

response to a question about which symptoms were

most troublesome, adolescents with RLS reported inabil-

ity to get comfortable (32.0%) and inability to stay still/

urge to move (29.6%), whereas parents of children with

RLS reported inability to get comfortable (30.9%) and

pain (22.2%) to be the most bothersome to their child.

Figure 3B provides symptom rates for children and ad-

olescents with moderate-to-severe RLS, which were typ-

ically higher than all with RLS. For most symptoms there

were not significant differences between children and

adolescents (Fig 3).

Sleep Disturbance

Children and adolescents with definite RLS were signif-

icantly more likely to have a history of difficulty falling

asleep or staying asleep at night, compared with those

who did not meet the criteria for definite or probable

RLS (overall: 69.4% vs 39.6%; P .001). Table 7 lists

the percentage with difficulty falling asleep or staying

asleep by age category. Adolescents with definite RLS

reported sleeping for a mean of 7.1 (median: 7) hours on

a school night. Hours of reported sleep was not available

for the 8- to 11-year-olds. Parents of 8- to 11-year-olds

with definite RLS reported a mean of 2.1 (median: 2)nights of disturbed sleep per week for their children,

whereas adolescents with definite RLS reported dis-

turbed sleep with a mean frequency of 3.2 (median: 3)

nights per week. This figure for adolescents is signifi-

cantly higher on average (t 4.0529; df 204; P .001)

than it is for the children. A total of 83.9% of parents of

children with definite RLS reported that their child,

when suffering from RLS symptoms, took 30 minutes

to fall asleep and would wake up on average 1.9 (SD:

1.5) times per night. A total of 77.6% of adolescents with

definite RLS reported taking 30 minutes on average to

TABLE 3 Prevalence of ProbableRLS: Age8 to 17Years

Age, y Survey

Participants

At Least Once per Month At Least 3 Times per

Month

At Least Twice per Week At Least Twice per Week

and Moderate-to-Severe

Distressa

n Prevalence

(95% CI)

n Prevalence

(95% CI)

n Prevalence

(95% CI)

n Prevalence

(95% CI)

811 4325 29 0.7% (0.40.9) 22 0.5% (0.30.7) 14 0.3% (0.20.5) 6 0.1% (0.00.2)

1217 6198 18 0.3% (0.20.4) 17 0.3% (0.10.4) 14 0.2% (0.10.3) 7 0.1% (0.00.2)

Total 10 523 47 0.4% (0.30.6) 39 0.4% (0.30.5) 28 0.3% (0.20.4) 13 0.1% (0.10.2)

CI indicates confidence interval.a Moderate-to-severe RLS; met probable 1 RLS criteria.

TABLE 4 Definite RLS:Gender Analysis

Age, y n (%)

RLS Moderate-to-Severe RLS

Male Female Male Female

811 39 (48.1) 42 (51.9) 13 (59.1) 9 (40.9)

1217 72 (57.6) 53 (42.4) 39 (60.0) 26 (40.0)

Total 111 (53.9) 95 (46.1) 52 (59.8) 35 (40.2)

Percentages are percent of male-female total.Moderate-to-severeRLS: at least twiceper week

andmoderate-to-severe distress. Allmale-femaledifferencesare nonsignificant by Pearson2.



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get to sleep when suffering from RLS symptoms and

would wake a mean of 2.5 (SD: 1.8) times a night.

Daytime sleepiness was reported in 21.0% of 8- to

11-year-olds and 33.6% of 12- to 17-year-olds with

definite RLS.

Perceived Consequences

Respondents were asked to select from a list of potential

correlates that they thought were related to their leg

discomfort (Fig 4A). For children with definite RLS, the

most commonly reported consequence of RLS symptoms

listed by parents was a negative influence on the childs

mood (53.1%), followed by an inability to sit still in the

afternoon or evening (46.9%), and next a lack of energy(29.6%). The most frequent effect of RLS symptoms

listed by adolescents with RLS was an inability to sit still

in the late afternoon or evening (60.8%), followed by a

negative influence on mood (47.2%), a lack of energy

(40.8%), and an inability to concentrate on schoolwork/

work (40.0%). For those with moderate-to-severe RLS,

many of the reported consequences were more preva-

lent, including a negative influence on mood and a lack

of energy (Fig 4B). For most perceived consequences,

there were not significant differences between children

and adolescents (Fig 4).

RLSDiagnoses, Treatment, FamilyHistory, andComorbid

Conditions

RLS Diagnoses

Consulting patterns for all children and adolescents with

definite RLS were investigated. Of the 81 children with

definite RLS, 38 (46.9%) were reported to have had 1

medical consultation for RLS symptoms in the 12

months before the survey and of 125 adolescents with

definite RLS, 64 (51.2%) reported a consultation. In

response to the question What diagnosis, if any, has

your child been given for these symptoms? the mostcommon medical explanation reported as given for the

RLS symptoms was the same for both children (16 of 38

consulting) and adolescents with definite RLS (29 of 64

consulting), namely that the symptoms were part of

normal development (44.1%). The percentage of those

whose medical consultation for RLS symptoms produced

a diagnosis of RLS was 23.7% (9 of 38) for children with

definite RLS and 21.9% (14 of 64) for adolescents with

definite RLS. The overall rates of a medical diagnosis of

RLS for all of those with definite RLS was, therefore,

11.1% (9 of 81) of children and 11.2% (14 of 125) of

adolescents.

Of the 22 children meeting the criteria for moderate-

to-severe RLS, 11 (50.0%) parents reported medical

consultation about the childs symptoms in the last 12

months, and of these, 3 (27.3%) reported that the child

received a diagnosis of RLS. Correspondingly, the par-

ents of 41 of 65 adolescents (63.1%) with moderate-to-

severe RLS reported that health care had been sought for

the RLS symptoms in the last 12 months, with 10

(24.4%) of 41 reporting a subsequent RLS diagnosis.

Thus, overall rates of medical diagnosis of RLS in the

moderate-to-severe groups were: 13.6% (3 of 22) for

children and 15.4% (10 of 65) for adolescents.

TABLE 5 Descriptionsof Sensory Complaints: Age8 to 11Years

Legs need to stretch

Ouchie

Too much energy, I really have to move

Ants crawling and aching feeling

Twitchy, jerky

My legs need a walk/jog

Legs feel full of energy; funny feelings in the legs, aching

Throbbing-ache; have the need to want to run; blood racing through legsI have to keep moving

It hurts, I cant sleep; when I try my legs tingle and I hurt

Legs hurt, cant go to sleep

Legs hurt and feel funny

She screams It hurts at bedtime

Nervous, need to be jiggled

Runaway legs, tweaky legs

At night my legs tingle and tickle; I want to be still but if I do they hurt my feet;

that is why I kick myself at night

Tingly, fuzzy, pressure

Tickly inside the leg

Crampy, uncomfortable

Fidgety, restless, too much energy

My legs cant get comfortable, they want to move around on their own

I feel like my legs wont be still

Legs feeling giggly or jumpy

They ache and feel awful

He says it feels like therere bugs in his bones

My legs feel funny; I want to move them; I feel frustrated; I cant sleep

That her legs felt creepy crawly

Like electricity flowing

I have a hard time falling asleep when my legs want to keep going; they feel

jumpy

Antsy, excited, exploding

My legs feel funny, they kinda hurt and I want to move them; I cant get

comfortable

Feel like they want to jump off my body; make me want to run and run until I

cant run any more

Ticklish legs, like jumping beansI feel like I need to shake my legs like my dad does

Fizzy legs; need to kick out, stretch out legs

Spider in her legs

Statements are in response to question 15: What words has your child used to describe the

discomfort in their legs?

TABLE 6 History of GrowingPains

RLS Status Age 811 y (N 4296) Age 1217 y (N 6180)

n % n %

No RLS 2571/4215 61.0 3924/6055 64.8

Definite RLS 69/81 85.2a 97/125 77.6b

Data are from question 2: Do they, or have they, experienced growing pains? answered by

parent. Note: percentages in Table 8 are for a medical diagnosis of growing pains rather than a

simple history of growing pains.a Pearson 2 for 8 to 11 years 27.214 (P .001).b Pearson 2 for 12 to 17 years 16.213 (P .001).



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Treatment

Ongoing treatment with prescription medication for

children and adolescents with definite RLS was reported

low, but similar: 6.2% (5 of 81) and 6.4% (8 of 125),

respectively. However, in only 3 cases total (1.5%) were

the medications listed those that might be considered

appropriate in the adult RLS literature44,45: ropinirole

(n 1) and codeine (n 2). Others listed for RLS

treatment were amitriptyline, celecoxib, methylpheni-

date, amphetamine/dextroamphetamine, atomoxetine,

coproxamol, and a topical antiinflammatory agent.

Clonidine and clonazepam were not mentioned.

FIGURE 3

A, Symptoms reported: childrenand adolescents with definiteRLS. B, Symptoms reported: children and adolescentswith moderate-to-severe RLS.a Significantdifference 8 to 11 vs12

to 17 years at the P .05 level.



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Family History of RLS

A family history of RLS was common in the definite 1

RLS group for children (n 70) and the definite RLS

group for adolescents (n 125). The definite 2 RLS

group for children (n 11) was not included for this

analysis because the presence of a first-degree relative

with RLS is part of entry criteria for this group (Fig 1). At

least 1 parent responding positively to the RLS question

was found in 71.4% (50 of 70) of the definite 1 RLSchildren and in 80.0% (100 of 125) of the definite RLS

adolescents. Both parents responding positively to the

RLS question was found in 17.1% (12 of 70) and 16.0%

(20 of 125) of families, respectively. Gender analysis of

parental RLS found 44 mothers and 18 fathers positive

for RLS of definite 1 RLS 8- to 11-year-olds, and 83

mothers and 37 fathers of definite RLS 12- to 17-year-

olds, resulting in parental female to male ratios of 2.4:1

and 2.2:1, respectively.

We compared children and adolescents meeting the

diagnostic criteria for RLS and having a positive family

history of RLS to those meeting the diagnostic criteria

but having no family history RLS. There were no signif-

icant differences for sleep disturbance (question 3) or for

any of the perceived consequences listed in Fig 4A (P

.05).

Comorbidity

A question on medical history was included in the sur-

vey, and respondents were asked to select from a list

which, if any, diagnoses had been received. The list

consisted of diagnoses that might potentially confound,

mimic, or interact with RLS (Table 8). As expected, a

medical diagnosis of growing pains (29.6% of children

and 36.8% of adolescents with RLS) was the most com-

mon diagnosis reported. These data on a medical diag-

nosis of growing pains should not be confused with the

data in Table 6, which refer to a history of growing pains

in response to the question Do they, or have they,

experienced growing pains? answered by the parent.

Other common medical diagnoses were attention-deficit

disorders (14.8% and 17.6%, respectively), depression

(3.7% and 14.4%, respectively), and anxiety disorders

(4.9% and 8.0%, respectively). Children or adolescents

with RLS in the United States were more likely to have

received a diagnosis for an attention-deficit disorder,

depression, or an anxiety disorder than children or ad-

olescents with RLS in the United Kingdom.

DISCUSSION

To our knowledge, this is the first large-scale, popula-

tion-based study of RLS prevalence and impact in chil-

dren and adolescents and is the first to use specific

pediatric RLS definitions in a general population survey.The most important finding in this study was the high

prevalence of definite RLS, 1.9% of children 8 to 11

years old and 2.0% of adolescents 12 to 17 years old. In

addition, about one quarter of the children and one half

of the adolescents with definite RLS met criteria for

moderate-to-severe RLS. The approximate 2% preva-

lence in 8- to 17-year-olds exceeds that of nonfebrile

seizure disorders (0.5%) and diabetes type 1 and 2

combined (1%) in this same age range, and is similar

to estimates of pediatric obstructive sleep apnea

(2%).37,46 This RLS prevalence is consistent with 7 large

epidemiologic studies in adults, which have found a 5%to 10% prevalence in the United States and Western

Europe,39 when adjusted for the fact that 25% of adult

RLS patients reported in 2 different studies onset of RLS

between 10 to 20 years old.39,40 This would give a pre-

dicted prevalence of 1.25% to 2.5%, surprisingly close

to the results from this survey. The only other pediatric

population-based study related to RLS that we are aware

of is a longitudinal study of French-Canadian children

that included a question about leg restlessness at bed-

time and found 6.1% of 1353 children ages 11 to 13

years to consistently have this complaint.42 Adding in the

other RLS diagnostic criteria would be expected to re-duce this number appreciably. Also, it should be noted

that the French-Canadian population has one of the

highest reported general-population RLS prevalence

rates, estimated at 15% to 20%.47,48

We found the prevalence of RLS in boys and adoles-

cent males similar to girls and adolescent females, which

is in sharp contrast to adult RLS studies that have con-

sistently reported a 2:1 female to male ratio. 4 Although

our survey emphasized current symptoms, parents re-

ported recall of onset of RLS in the 8 to 11-year-olds at

5 years of age in 15% and 5 to 7 years old in 63%,

indicating that children younger than those included in

our study may be affected by RLS.

The descriptions of RLS feelings reported by the 8- to

11-year-olds (Table 5) provided convincing data to us

that this survey did successfully measure restless legs

symptomatology. Themes of bug-like sensations, ticklish

feelings, electricity, jumpiness, and energy were com-

mon and are consistent with our extensive clinical ex-

perience diagnosing RLS in children and adolescents. A

history consistent with RLS was reported by more than

two thirds of parents of the definite RLS children and

adolescents, supporting this aspect as helpful in the di-

agnostic criteria for RLS in children and adolescents. 49 Of

TABLE 7 DifficultyFalling Asleep or Staying Asleep atNight

RLS Status Age 811 y (N 4296) Age 1217 y (N 6180)

n % n %

No RLS 1427/4215 33.9 2639/6055 43.6

Definite RLS 55/81 67.9a 88/125 70.4b

Data are from question 3: Does your child have difficulty falling asleep or staying asleep?

answered by parent.a

Pearson 2

for 8 to 11 y 45.944 (P .001).b Pearson 2 for 12 to 17 y 35.680 (P .001).



11/16

note, there were a remarkable number of families in

which both parents reported RLS symptoms (1 of 6

families). This extra genetic load may play a role in the

age of onset and severity of RLS in childhood. The in-

creased prevalence of RLS symptoms in mothers com-

pared with fathers is consistent with adult prevalence

studies, which have shown an approximate 2:1 ratio of

females to males.4 Parity is considered a major factor in

explaining this gender difference.4

It is likely that primary and secondary RLS cases are

included in our data. Although Table 8 lists 17 medical

diagnoses that we asked about, we did not include a

question about all active medical conditions, we did not

ask about all current medications, and this large survey

FIGURE 4

A, Perceived consequences: childrenand adolescentswith definiteRLS. B, Perceived consequences:children and adolescentswith moderate-to-severeRLS.a Significant difference 8 to

11 vs 12 to 17 years at the P .001 level; b significant difference 8 to 11 vs 12 to 17 years at the P .05 level.



12/16

did not include screening laboratory tests. Known causes

of secondary RLS include renal failure, pregnancy, pe-

ripheral neuropathy, and some medications.50,51 None-

theless, it is probable that the majority of our cases are

primary RLS given the relatively low occurrence of these

factors in the age range studied and the predominance of

primary RLS in cases with onset before age 45.52 We did

find self-reported medical diagnoses of anemia or irondeficiency, which are known aggravating factors for

RLS, in 2.5% children 8- to 11-year- olds and 4.8% 12-

to 17-year-olds.

Growing Pains

Beginning with Ekboms work on RLS in the 1940s to

1970s, there has been controversy over the relationship

of growing pains to childhood RLS.23,35,53 We believe our

data shed some light on this issue. A history of growing

pains was common in 8- to 17-year-olds with RLS (over

three quarters), but it was also common in those withoutRLS (almost two thirds). Although statistically signifi-

cant and useful for group data, this difference is not

likely to be a key factor in the decision as to whether an

individual patient has RLS. However, we have found

growing pains to be a clinically useful lead-in question

to a more specific discussion of RLS symptoms. Perhaps

more relevant is the disparately high medical diagnosis

rate of growing pains in children with RLS compared

with a low medical diagnosis of RLS (Table 8), suggesting

that the much more specific diagnosis of RLS was missed

and that an opportunity for treatment was also missed.

Impact

The impact of RLS in children and adolescents seems to

be substantial. The frequency and severity of RLS feel-

ings were reported as moderate-to-severe in about one

quarter of the 8- to 11-year-olds and about half of the

12- to 17-year-olds (at least twice per week and moder-

ately or extremely distressing). Sleep disturbance was

very commonly reported in the children and adolescentsmeeting criteria for definite RLS, exceeding two thirds,

and much more than in those without RLS (Table 7).

Perceived consequences of RLS were common, with dif-

ficulty sitting in the late afternoon or evening, a negative

effect on mood, a lack of energy, and an inability to

concentrate frequently reported in the definite RLS

groups, and even more pronounced in the moderate-to-

severe RLS groups (Fig 4). Given the emerging literature

on the effect of sleep disturbance on cognitive and af-

fective function in children and adolescents, these as-

pects are of notable concern.5460 It has been our experi-

ence that in more severe cases of pediatric RLS,treatment can be of benefit. However, it should be noted

that there are currently no US Food and Drug Adminis-

trationapproved treatments for RLS in children and

adolescents.

Diagnosis and Treatment

Our data indicate that RLS is uncommonly diagnosed in

children and adolescents, even for those who reported

that they sought medical care for the symptoms. Less

than 1 in 4 who sought medical care received an RLS

diagnosis, with diagnosis rates only marginally better for

TABLE 8 Self-ReportedMedical Diagnoses: Children andAdolescentsWithDefinite RLS

%

United Kingdom

(N 90)

United States

(N 116)

United Kingdom and United States

(N 206)

811 y

(n 35)

1217 y

(n 55)

811 y

(n 46)

1217 y

(n 70)

811 y

(n 81)

1217 y

(n 125)

Growing painsa 22.9 29.1 34.8 42.9 29.6 36.8

ADD/ADHD 2.9 3.6 23.9 28.6 14.8 17.6

Depression 0.0 12.7 6.5 15.7 3.7 14.4

Restless legs 2.9 10.9 15.2 12.9 9.9 12.0

Anxiety disorder 0.0 1.8 8.7 12.9 4.9 8.0

Insomnia 0.0 3.6 2.2 11.4 1.2 8.0

Sleep disorder 5.7 3.6 4.3 7.1 4.9 5.6

Anemia/iron deficiency 2.9 3.6 2.2 5.7 2.5 4.8

Mental disability 2.9 1.8 0.0 7.8 1.2 4.8

Sleep apnea 0.0 3.6 2.2 5.7 1.2 4.8

Seizures/epilepsy 0.0 5.5 0.0 2.9 0.0 4.0

Nighttime cramps 2.9 3.6 2.2 2.9 2.5 3.2

Spinal injury/disk problems/sciatic pain 0.0 1.8 0.0 2.9 0.0 2.4

Tourettes syndrome 0.0 0.0 0.0 2.9 0.0 1.6

Rheumatoid arthritis 0.0 1.8 0.0 0.0 0.0 0.8

Periodic limb movement disorder 0.0 0.0 0.0 0.0 0.0 0.0Diabetes 0.0 0.0 0.0 0.0 0.0 0.0

aThese data report a medical diagnosis of growing pains compared with the simple history of growing pains reported in Table 6.



13/16

those moderately to severely affected. Most often a med-

ical explanation of normal development was reported.

Because RLS is not generally recognized as a medically

significant disorder, there may be a tendency to discount

these symptoms as unimportant or interpret them as an

expression of more familiar medical conditions. In cases

where medication was prescribed, only 1 of the medica-

tions reported would be considered first-line treatmentfor RLS in the adult literature.1,45

Because this was a survey and not a clinical evalua-

tion, it is possible that other diagnoses could explain the

symptoms of the children and adolescents who met def-

inite RLS criteria in our study. However, the extensive

inclusion and exclusion criteria used in this study, as

well as rigorous application of NIH criteria, make this

unlikely in our opinion. It should be noted that the NIH

definite RLS criteria in those 12 years old requires

more symptoms than are required for a diagnosis in

adults. This was devised to avoid overdiagnosis in chil-

dren. More likely, the low medical diagnosis rates of RLSreflect a lack of awareness among those providing med-

ical care for children and adolescents. In 2 major US

pediatric textbooks RLS is mentioned sparingly, a total of

2 paragraphs.46,61 Low awareness of RLS has been docu-

mented for those who provide health care for adults,

although there is evidence that awareness is improv-

ing.3,21,62

Comorbidity

Comorbidity of definite RLS with medically diagnosed

ADHD, depression, and anxiety disorders in our study is

of interest. These all were found at rates higher thandiagnosis rates reported in the general pediatric popula-

tion,63,64 but caution regarding these findings is war-

ranted given the small sample size in some of the cells. In

addition, there were much lower diagnosis rates in the

United Kingdom than in the United States, perhaps re-

flecting lower occurrence but more likely because of

higher diagnosis and treatment rates of some behavioral

conditions in the United States than in the United King-

dom and Europe.65,66 There is considered to be a complex

relationship between ADHD and sleep disorders in chil-

dren, and a substantial literature exists.38,58,67,68 In adults

with RLS, there are increased rates of depression,19 anx-

iety,69,70 and ADHD71 compared with the general popu-

lation. Although various theories exist, there is some

evidence that RLS and these conditions have a negative

interactive effect with each other, and that their associ-

ation may reflect some shared common pathology.19,67

Limitations

Methodologic issues should be considered in the inter-

pretation of our results. First, the ascertainment of RLS

status was by self-report via the parents or adolescents,

not by clinical interview. Although it is possible that

other conditions could have been reported as RLS symp-

tomatology, a detailed set of questions to exclude known

mimics of RLS was part of the survey. It is reassuring that

there were low rates of diabetes, arthritis, and sciatic

problems in the RLS cases found, because these are

known confounders of the diagnosis in adults. Also, in

the clinical setting the diagnosis of RLS is based on

history, not requiring physical examination for a positive

diagnosis. Second, our survey was conducted in a con-venience sample of Internet users. United Kingdom cen-

sus data suggest that 55% of households in the United

Kingdom had Internet access in July 2005.72 US census

data from October 2003 provided by the US Department

of Commerce indicated that 55% of households in the

United States had Internet access and that access was

strongly associated with income.73 However, by spring

2004 the Internet usage rate was measured at 63% for

adults in the United States, and the income gap was

closing.74 To the extent that the prevalence of RLS, par-

ent observation of symptoms, and health care utilization

are associated with factors influencing Internet use orpropensity to volunteer in research surveys, our results,

like those from all similar population studies, may be

biased. Third, the 10 523 participating households rep-

resents a 4% subset of the initially invited households,

which itself is a subset of the total United Kingdom and

US households. To limit enrollment bias we did not

disclose the specific survey topic until all eligibility cri-

teria were met and enrollment was terminated after the

2 weeks it took to obtain an adequate sample size.

Fourth, although the NIH pediatric RLS diagnostic crite-

ria are a consensus of expert opinion, these criteria have

not been validated extensively in the clinical setting.Fifth, in families where there was a parent with RLS, it

is possible that those parents would have been more

likely to identify the symptoms in their children influ-

encing the prevalence rates in familial cases. Having the

adolescents complete the RLS questions directly and

having the younger children present when the parent

completed the questions about sensory symptoms

should have reduced this type of bias.

CONCLUSIONS

This large, population-based study found restless legs to

be quite prevalent in children and adolescents aged 8 to

17 years. Many of these children and adolescents hadmoderately to severely distressing symptoms and re-

ported that RLS adversely affected both sleep and day-

time function. Medical diagnosis rates of RLS were low,

and treatment was uncommon.

ACKNOWLEDGMENT

We thank Trevor Brown of Premark, Inc, for assistance

in organizing this project.

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DOI: 10.1542/peds.2006-27672007;120;253Pediatrics

Myers and Luigi Ferini-StrambiDaniel Picchietti, Richard P. Allen, Arthur S. Walters, Julie E. Davidson, Andrew

The Peds REST StudyRestless Legs Syndrome: Prevalence and Impact in Children and Adolescents

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rights reserved. Print ISSN: 0031-4005. Online ISSN: 1098-4275.Grove Village, Illinois, 60007. Copyright 2007 by the American Academy of Pediatrics. Alland trademarked by the American Academy of Pediatrics, 141 Northwest Point Boulevard, Elkpublication, it has been published continuously since 1948. PEDIATRICS is owned, published,PEDIATRICS is the official journal of the American Academy of Pediatrics. A monthly
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Documents

The PEDS Rest Study: Restless Legs Syndrome