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Pediatric Sleep Medicine: A brief overview from A to Zzzzzz….

Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

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Page 1: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

Pediatric Sleep Medicine:

A brief overview from A to Zzzzzz….

Page 2: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

Introduction:

Sleep related upper airway problems are common in pediatrics

Behavioral sleep problems are also common Underlying medical and anatomic problems

increase the risk for and severity of these conditions

Involved testing, incomplete understanding and a general lack of “evidence” further complicates the diagnosis and management of pediatric sleep disorders

Page 4: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

The Biology of Sleep:

Circadian System:– Circadian rhythms exist in

all living things» Sleep-wake cycle is one of

many examples– Circadian clock is located

in the suprachiasmatic nucleus (SCN)

» SCN neurons generate and maintain an oscillating rhythm via “clock” genes and their products

Page 5: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

The Biology of Sleep:

The human Circadian rhythm is slightly longer than 24 hours and must be set or entrained to match our daily schedules

Light, physical activity and melatonin are the most potent “entrainers” (zeitgebers):– These can work to favor or

oppose sleep In general, when the rhythm is

out of synch with scheduling demands, Circadian Rhythm Sleep Disorders are present

Page 6: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

The Biology of Sleep:

The Homeostatic System:– “Process S” (Sleep drive) is dependent upon the

duration and quality of prior sleep and waking:» The longer you have been awake, the greater the drive to sleep

and vice versa– After the main sleep period, the “homeostat” has been

re-set and the drive to sleep is low– If there is an abnormality of sleep or if sleep is

restricted, then Process S (the drive to sleep) will remain strong and the individual will be sleepy at inappropriate times

Page 7: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

The Biology of Sleep:

Ideally the Circadian rhythm and Homeostatic drive are synchronized and the sleep-wake cycle is smooth and regular

In general:– “Circadian rhythm sleep disorders” occur when the

circadian rhythm is desynchronized from the demands of everyday life

– “Homeostatic or intrinsic sleep disorders” result from problems with sleep quality, quantity or regulation

Page 8: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

Pediatric Sleep:What is normal?

Respiration during sleep:– Quiet and subtle

Sleep environment:– Infancy:

» Back-to-Sleep» Safe crib» No co-sleeping» Rooming in for 6-months» No smoking

– Childhood:» Quiet and comfortable» No stimulation» No electronics

Page 9: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

General Sleep Hygiene:

Establish routine:– Consistent bedtime and

wake up time– Consistent meals and naps– Bedtime ritual:

» Transitional objects as age-appropriate

– Increase exercise:» Not after dinner though…

– Wind down period:» Quiet activity» Soft light

– Sleep charts if needed

Page 10: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

Sleep Hygiene:Is there any hope?

A large study (n=565) of pre-school children evaluating the use of healthy media on sleep quality and problems:– Risk factors for poor sleep include:

» High levels of media use» Bedtime use of media» Frightening or violent media content

– In this cohort problems with sleep latency were most commonly reported

– Substitution of pro-social and educational media in a randomized study:

» Resulted in fewer sleep problems over an 18-month follow up period

Garrison et al. Pediatrics 2012;130:492-499

Page 11: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

Sleep Hygiene:Is there any hope?

A small pilot study in adolescents aged 10-18 years:– F.E.R.R.E.T. intervention:

» Food» Emotions» Routine» Restrict» Environment» Timing

– Short term improvements in sleep hygiene and other outcomes:» Sleep hygiene scores» Sleepiness scores» BMI z-scores

Tan et al. BMC Pediatrics 2012, 12:189

Page 12: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

Theme Rule 1 Rule 2 Rule 3

Food No food or drink 30 minutes before bed

Avoid food and caffeine 3 hours before bed

No alcohol or smoking 3 hours before bed

Emotions Set a time for thinking and planning each day

Wind down and relax 30 minutes before bed

Try not to worry, think or plan while in bed

Routine Wake up and go to sleep same time each day

Turn lights on when you wake, Dim lights before bed

Keep the same sleep routine each day

Restrict No electronics 30 minutes before bed

No exercise 3 hours before bed

Bed is for sleeping only

Environment Comfortable bed clothes and bed

Light, temperature and noise

Keep clocks faced away from bed

Timing Sleep for the recommended amount of time

Remember 30 minutes and 3 hours

Try to stick to the rules

Tan et al. BMC Pediatrics 2012, 12:189

Page 13: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

Pediatric Sleep:What is normal?

Typical sleep requirements throughout childhood:

Age group Age Sleep needInfants 3 to 12 months 14-15 hoursToddlers 1 to 3 years 12-14 hoursPreschoolers 3 to 5 years 11-13 hoursSchool-aged 6 to 12 years 10-11 hoursAdolescents 12 to 18 years 8.5-9.5 hours

Meltzer and Mindell Psychiatr Clin N Am (2006) 1059-1076

Page 14: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

Pediatric Sleep:What is normal?

Typical patterns of daytime sleep throughout childhood:

Age group Daytime Sleep

1 week 8 hours

1 month 7 hours

3 months 5-6 hours

6 months 3-4 hours

9 months 2.5-3.5 hours

12 months 2-3 hours

18 months 2 hours

2-3 years 1-2 hours

Most children eliminate regular daytime naps between the age of 3-5 years

Page 15: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

How much sleep are American children and adolescents getting?

Age Group Recommendation Study Finding

Infants (3-11 mo) 14-15 h 12.7 h

Toddlers (12-35 mo) 12-14 h 11.7 h

Preschoolers (3-6 yr) 11-13 h 10.3 h

School age (1st-5th grade) 10-11 h 9.5 h

Adolescents (6th-12th grade) 9.25 h 7 h

From the “Sleep in America Polls” 2004 & 2006

Page 16: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

Adolescents Living the 24/7 Lifestyle:

Real world assessment of adolescent (n=100, aged 12-18 years) technology and caffeine use:– 66% had television in bedroom– 30% had a computer in the bedroom– 90% had a cell phone– 79% had an MP-3 player– 85% with caffeine intake

Self-reported activities after 9PM:– Watching TV– Text messaging

“On average, adolescents engaged in 4 technology activities after 9M”

Calamaro et al. Pediatrics 2009;e1005-e1010

Page 17: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

Adolescents Living the 24/7 Lifestyle:

Multi-tasking was associated with worse sleep and daytime consequences:– 20.6% of the cohort obtained 8-10 hours of sleep per night– 33% of the cohort reported falling to sleep at school– More multi-taking was associated with lower sleep times and

higher caffeine intake» Television in bedroom did not correlate with sleep time

Caffeine intake:– Timing was skewed to impair sleep:

» 6-8AM 18.7%» 3-5PM 25.3%» 6-8PM 21.3%

Calamaro et al. Pediatrics 2009;e1005-e1010

Page 18: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

Pediatric Sleep Disorders:A working list

Normal sleep:– Developmental evolution throughout childhood– Usually defined by satisfied parents!

Behavioral sleep disorders:– Developmental evolution throughout childhood– Overlap syndrome with influence of cultural and societal norms– Usually defined by dissatisfied/frustrated parents!

Parasomnias or Transitional Disorders:– Developmental evolution throughout childhood– Usually defined by frightened parents!

Page 19: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

Pediatric Sleep Disorders:A working list

Breathing disorders during sleep:– Broad spectrum of clinical syndromes and

presentations– A number of common manifestations– Parents may be unaware of concerning symptoms!

Neurological disorders:– Less common in general– Children with special healthcare needs can be very

challenging

Page 20: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

Components of a Pediatric Sleep Evaluation:“BEARS”

Mnemonic for:» Bedtime» Excessive Daytime Sleepiness» Awakenings» Regularity» Snoring

Based on the four most common symptoms of pediatric sleep disorders:

» Difficulty with sleep onset» Problems that disrupt sleep» Inability to awaken from sleep at the desired time» Daytime sleepiness

Rosen, GM: “Case-Based Analysis of Sleep Problems in Children” in Principles and Practice of Pediatric Sleep Medicine

Page 21: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

Common Non-Respiratory Sleep Problems: A working list

Sleep talking Bruxism Night terrors Rhythmic movements Behavioral insomnia of childhood Confusional arousals Sleepwalking Nightmares Insomnia Delayed Sleep Phase Restless Leg Syndrome Narcolepsy

Adapted from: Moore, M et al.: CHEST 2006; 1252-1262

Page 22: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

Age Distribution of Common Non-Respiratory Sleep Problems:

Infant & Toddler (1-2 yrs):– Behavioral Insomnia of Childhood – Rhythmic Movements

Preschool (3-5 yrs):– Behavioral Insomnia of Childhood – Rhythmic Movements– Sleep Terrors

School age (6-12 yrs):– Insufficient Sleep– Bedtime Resistance– Sleep-Walking

Adolescence (13-18 yrs)– Insufficient Sleep– Delayed Sleep Phase– Narcolepsy

Adapted from: Moore, M et al.: CHEST 2006; 1252-1262

Page 23: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

Unique Aspects of Pediatric Sleep in Otherwise Healthy Infants and Children:

Another working list:– Delayed Settling– Trained Night Feeder– Trained Night Awakening– Developmental Night Awakening– Prolonged Routines– Curtain Calls– Bedtime Fears– Parasomnias

Management of these “problems” is facilitated by a good understanding of normal childhood development and

confident supportive parenting skills

Page 24: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

Night Terrors:Parent is terrified

Slow Wave Sleep:– Usually in the first or

second cycle of sleep– Incidence ~5%, may be

familial– Rare before 18-24 mo– Can cluster – Self resolve by 8-10 yrs

Child is asleep:– Sympathetic output:

» Sweating, thrashing, screaming

– Child has no memory of the event

Page 25: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

Night Terrors:

Management:– Reassure parents:

» No need to awaken child» Safety» Avoid secondary gain

– Phase shift:» Afternoon nap to decrease

Stage 3 sleep» Awaken 1 hour into sleep

– I do not favor medications:» Benzodiazepines

Page 26: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

Nightmares:Child is terrified

Occur during REM periods:– Latter part of the night– Most common in

preschoolers:» Learning about the “hard

knocks” of life » Stress and other

disruptions to routine– Child awakens and should

remember dream:» Child is frightened

Page 27: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

Nightmares:Child is terrified

Simple management:– Reassurance– Bedtime ritual and security

object to prepare for good dreams

– Brief intervention in child’s room

– Avoid secondary gain– I do not favor medications

Complex management:– Counseling– Prazosin– Relaxation

Page 28: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

Select features of Nightmares and Night Terrors:

Night Terrors: Sudden onset Autonomic nervous system

activity Behavioral manifestations

of fear Difficulty arousing the child Confusion upon awakening Amnesia of the episode Dangerous behaviors

Nightmares: Recurrent episodes Recall of a disturbing dream Various emotions, but none

will be good Full awakening and alerting Recall is good Delayed return to sleep Episodes occur in the latter

half of the sleep period

Adapted from: ICSD 2nd ed: Diagnostic and Coding Manual. AASM; 2005

Page 29: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

Behavioral Insomnia of Childhood:

Behavioral Insomnia of Childhood:– Bedtime resistance– Frequent night time awakenings– 10-30% of infants and toddlers

Sleep-onset association type:– Certain conditions must be met to facilitate sleep– Positive associations: Self comfort– Negative associations: External stimuli

Limit setting type:– Bedtime stalling or refusal

Combined type

Page 30: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

Behavioral Insomnia of Childhood:Sleep-onset association type: Falling asleep is an extended

process Falling asleep requires special

conditions When conditions are not met,

sleep latency is prolonged and sleep is disrupted

Nighttime awakenings require caregiver intervention

Limit-setting type: Difficulty with sleep initiation

and maintenance Stalling and refusal to go to bed

or return to bed after nighttime awakening

Caregiver cannot set limits to establish sleep hygeine

Adapted from: ICSD 2nd ed: Diagnostic and Coding Manual. AASM; 2005

Page 31: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

Behavioral Insomnia of Childhood:

General treatment principles:– Not particularly evidence-based– Sleep hygiene:

» Bedtime routine» Learn self-soothing

– Extinction/Graduated extinction:» Ignore the behavior until it is extinguished:

Extinction burst

– Learning about limits:» Parenting skills» Bedtime fading

Page 32: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

Prolonged Routines and Curtain Calls:

May be a phase shift or limit setting issue:– Manage limits and increase daytime attention in

general– Involve child in the plan– Parents need to “be strong:”

» No escalation: Lead quietly back to bed– Reward positive behaviors:

» Extra story the next night» Other systems

– Physical barriers if needed:» Gates, locks» Parent sits outside door

Page 33: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

Insufficient Sleep:

Sleep deprivation:– De-emphasis of sleep due to other commitments– Cumulative sleep debt results in:

» Fatigue, mood changes, illness» School tardiness» Falling asleep in school

– Sleepy driver accidents or fatalities Clinical clues:

– Needing to be awakened for school– Sleeping 2 hours or more on weekends and vacations– Falling asleep at inappropriate times– Behavior and mood differ after getting adequate sleep

Page 34: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

Delayed Sleep Phase Syndrome:

Circadian rhythm disorder with delayed sleep-wake times:– 2 or more hours– Interfering with daily schedules activities (school)– Most common in adolescents

Night owl syndrome:– Inability to fall asleep at “normal” time

» Bedtimes of 0200-0300– Sleep onset/efficiency and quality are normal at this shifted time– Treatment is difficult:

» Chronotherapy—phase advancement or phase delay» Melatonin to advance the circadian clock» Light therapy

Page 35: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

The Spectrum of Pediatric Sleep Disordered Breathing:

Central Sleep Apnea Syndromes:– May or may not be developmental– CNS Disorders

Hypoventilation Syndromes:– Congenital Central Hypoventilation Syndrome– Neuromuscular

Respiratory Dysrhythmia Syndromes:– May be developmental– CNS Disorders

Awake respiration may or may not be normal Laboratory studies may actually be helpful

Page 36: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

The Spectrum of Pediatric Sleep Disordered Breathing:

Airway Obstructive Syndromes A number of conditions which are possibly

interrelated:– Primary snoring– Upper airway resistance syndrome– Obstructive sleep apnea syndrome

All three are manifest by snoring Respiration during wakefulness usually normal Routine laboratory studies not generally helpful

Page 37: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

Primary Snoring:

Defined as snoring in the absence of apnea, gas exchange abnormalities or arousals

Snoring is a common “symptom:”– Up to 10% of children snore regularly– The majority have Primary Snoring

Consequences of Primary Snoring are unclear:– No evidence of progression to OSA…– Some developmental consequences are proposed– No treatment is currently recommended

Page 38: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

“He snores just like his father!”Maybe that is not so cute…

A large cohort study (n=249 parent-child pairs) evaluated snoring in preschool children:– Parental report of loud snoring more than twice weekly

that was absent (no snoring), transient (snoring at age 2 but not age 3) or persistent (snoring at both ages):» Non-snorers: 68% » Transient snorers: 23%» Persistent snorers: 9%

Beebe et al.: Pediatrics 2012;130:382-389

Page 39: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

“He snores just like his father!”Maybe that is not so cute…

Risk factors for snoring:– Higher BMI– Pre and post natal tobacco smoke exposure– African American race– Lower parental education and family income– Absent or shorter duration of breast feeding

Persistent snoring was associated with adverse behavioral and developmental outcomes:– Behavioral:

» Hyperactivity» Depression» Attention

Beebe et al.: Pediatrics 2012;130:382-389

Page 40: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

Upper Airway Resistance Syndrome:

Defined as a syndrome of snoring and prolonged partial upper airway obstruction:– Repetitive episodes of increased work of breathing that

leads to arousal:» Diagnosed by polysomnogram with evidence of increased

work of breathing (paradoxical breathing) and arousal

– Apnea, hypopnea and gas exchange abnormality are generally absent

– Treatment options are the same as those for obstructive sleep apnea syndrome

Page 41: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

Obstructive Sleep Apnea Syndrome:

A syndrome occurring during sleep characterized by:– Obstructive apnea– Partial upper airway

obstruction – Hypoventilation– Hypoxemia

Incidence thought to be 1-3% of all children:– Up to 40% of specialty

referred patients with snoring

Obstructive apnea with desaturation

Page 42: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

Obstructive Sleep Apnea:

Imbalance of forces:– Airway opening and

closing pressures– An imbalance between

these forces balance due to anatomic or neuromuscular factors results in inappropriate airway closure

– Retropalatal– Retroglossal

Katz, ES: Proc Am Thorac Soc Vol 5, 2008

Page 43: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

Approaching the Patient with Possible Sleep Disordered Breathing:

Sleep & Developmental History Co-existing conditions Physical Examination:

– Growth parameters– Upper airway anatomy and

patency– Heart sounds– Chest wall configuration– Awake gas exchange

Potential testing:– Chest and airway/neck films– ECG – Blood tests are usually normal– Specialized testing

Rating tonsil hypertrophy

Page 46: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

Adenotonsillar Hypertrophy:

Most common “cause” of OSA in children

Most prevalent in young school age children:– Related to normal lymphoid

hyperplasia ages 2-6 years– Tonsil and adenoid size

related to severity but not presence of OSA

Most common reason for referral to our lab

Page 47: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

Diagnosis of Obstructive Sleep Apnea Syndrome:

Literature supports the benefits of early diagnosis and treatment

Obstructive sleep apnea cannot be diagnosed based upon history and physical exam alone:– Sleep history should be obtained– Screen for symptoms of OSA– Physical examination features

Polysomnography is the “gold standard:”– Expensive, but cost-effective when used correctly

Page 48: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

Symptoms of Pediatric Obstructive Sleep Apnea Syndrome:

Nocturnal:– Symptoms correlate with severity:

» Snoring» Labored breathing» Sweating» Restless sleep» Unusual sleep position» Enuresis

Normal breathing during sleep in a child should be a subtle finding!

Page 49: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

Symptoms of Pediatric Obstructive Sleep Apnea Syndrome:

Daytime:– May be absent– Mouth breathing– Nasal obstruction– Hyponasal speech– Increased attention being given

to neurobehavioral aspects of OSA:» Attention problems» Learning problems» Behavior problems» Hyperactivity

Mouth breathing in adenoidal hypertrophy

Page 50: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

Complications of Pediatric Obstructive Sleep Apnea Syndrome:

Growth related:– Failure to thrive reported:

» Increased work of breathing

» Decreased growth hormone secretion

Cardiopulmonary:– Pulmonary hypertension– Cor pulmonale– Systemic hypertension– Right or left ventricular

hypertrophy

Page 51: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

Treatment of Pediatric Obstructive Sleep Apnea Syndrome:

Healthy children:– Adenotonsillectomy is

usually curative:» Post-operative risk factors

well documented– Mild OSA:

» Intranasal Steroids» Montelukast» Antihistamines

Other items to address:– Chronic or allergic rhinitis

Co-morbidities:– Obesity– Asthma

Tonsillar hyperplasia and infection

Page 52: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

Adenoid size (adenoidal/nasopharyngeal ratio) significantly decreased with montelukast.

Goldbart A D et al. Pediatrics 2012;130:e575-e580

©2012 by American Academy of Pediatrics

Page 53: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

Montelukast treatment resulted in a significant improvement in the OAI. The pretreatment average of 3.7 ± 1.6 before (pre) dropped to 1.9

± 1.0 after (post) treatment; P < .05.

Goldbart A D et al. Pediatrics 2012;130:e575-e580

©2012 by American Academy of Pediatrics

Page 54: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

Treatment of Pediatric Obstructive Sleep Apnea Syndrome:

– Nasal mask ventilation:» CPAP/BiPAP®

» Can be implemented post-operatively if needed

– Supplemental oxygen:» Use with caution

– Devices:» Not well studied

Efficacy and safety unknown…

Page 55: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

Recently Updated Clinical Practice Guideline:

Clinical practice guideline: Diagnosis and Management of Childhood Obstructive Sleep Apnea Syndrome:– www.pediatrics.org/cgi/doi/10.1542/peds2012-16711. All children should be screened for snoring

2. PSG should be performed for snoring and symptoms/signs of OSAS

3. Adenotonsillectomy is recommended as first-line treatment of patients with ATH

4. High risk patients should be monitored as inpatients post-operatively

5. Patients should be re-evaluated post-operatively

6. CPAP is recommended

7. Weight loss is recommended

8. Intranasal corticosteroids are an option in mild OSAS

Page 56: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

The diagnosis and management of pediatric sleep disorders is important!

A large (~11,000) cohort study evaluated sleep disordered breathing (SDB) and behavioral sleep problems (BSP) in children:– SDB defined by:

» Snoring, Witnessed apnea, Mouth breathing– BSP defined by:

» Evaluation of sleep behaviors “A history of either SDB or BSP in the 1st 5-yrs of life was

associated with the need for SEN at 8 yrs of age. Findings highlight the need for pediatric sleep disorder screening”

Bonuck et al.: Pediatrics 2012;130:634-642

Page 57: Pediatric Sleep Medicine: A brief overview from A to Zzzzzz…

Some Final Thoughts:

Sleep disordered breathing common in pediatrics:– OSA is just one example– Many underlying medical

conditions can affect sleep Behavioral sleep problems

are also common:– Treatment can be

challenging– Sleep hygiene is critical

Important outcomes require clarification

Lean CPAP Patient