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Medical University of South Carolina, Data Coordination Unit
Form 244: Informed Consent Version 4 Page 1 of 1 Version 1 (02-MAY-2019)
Sleep SMART Subject: └──┴──┴──┴──┴──┴──┘
Q01 Informed consent form version
Derived by WebDCU.
Q02 Signed informed consent obtained
O No
O Yes, signed by subject
O Yes, signed by Legally Authorized Representative
Q03 If Q02 is ‘Yes’ Informed consent form language
O English
O Spanish
O Other
Q04 If Q03 is ‘Other’ Other language specify
Q05
If Q02 is ‘Yes’
Date informed consent was signed ___ ___ - ___ ___ ___ - ___ ___ ___ ___ dd-mmm-yyyy
Q07 Signed informed consent form file upload
PDF file only.
Q08
If Q02 is ‘Yes, signed by Legally
Authorized Representative’
Reason subject was unable to consent
Q09 If Q02 is ‘No’ Reason signed informed consent not obtained
Q10 Informed consent obtained via eConsent O No
If Q02 is ‘Yes’
O Yes
Q11 Informed consent obtained remotely O No O Yes
General comments
Version 4
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Medical University of South Carolina, Data Coordination Unit
Form 101: Eligibility Page 1 of 2 Version 3 (28 Jul-2021)
Sleep SMART Subject: └──┴──┴──┴──┴──┴──┘
All eligibility criteria must be met prior to enrollment.
A05 Protocol version
A01 Date of stroke symptom onset
If unknown, enter date last known normal.
___ ___ - ___ ___ ___ - ___ ___ ___ ___ dd-mmm-yyyy
A02 Date of arrival at enrolling hospital ___ ___ - ___ ___ ___ - ___ ___ ___ ___ dd-mmm-yyyy
A03 Subject previously enrolled in Sleep SMART O No O Yes
A04 If A03 is Yes
Previous Subject ID
If the subject has been enrolled multiple times, enter any previous subject ID.
___ ___ ___ ___ ___ ___
Inclusion Criteria
Q01 Subject 18 years of age or older
Derived from Subject Enrollment Q06 O No O Yes
Q02 TIA with ABCD2 ≥ 4 or ischemic stroke within the last 14 days O No O Yes
Exclusion Criteria
Q03
Pre-event inability to perform all of own basic ADLs
Because trial eligibility mandates ability to perform all ADL’s without assistance from another person, pre-stroke/TIA mRS in Sleep SMART is generally 0-3.
Please see data collection guidelines related to the pre-stroke mRS.
O No O Yes
Q04 Incarcerated O No O Yes
Q05 Known pregnancy O No O Yes
Q06 Current mechanical ventilation or tracheostomy O No O Yes
Q07 Current use of positive airway pressure, or use within one month prior
to stroke O No O Yes
Combo box
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Form 101: Eligibility Page 2 of 2 Version 3 (28 Jul-2021)
Sleep SMART Subject: └──┴──┴──┴──┴──┴──┘
Q08 Anatomical or dermatological anomaly that makes use of CPAP
interface unfeasible O No O Yes
Q09 Severe bullous lung disease O No O Yes
Q10 History of prior spontaneous pneumothorax or current pneumothorax O No O Yes
Q11 Hypotension requiring current treatment with pressors O No O Yes
Q12 Other specific medical circumstances that conceivably, in the opinion of
the site PI, could render the patient at risk of harm from use of CPAP O No O Yes
Q13 Massive epistaxis or previous history of massive epistaxis O No O Yes
Q14 Cranial surgery or head trauma within the past 6 months, with known
or possible CSF leak or pneumocephalus O No O Yes
Q15 Recent hemicraniectomy or suboccipital craniotomy (i.e. those whose
bone has not yet been replaced) or any other recent bone removal procedure for relief of intracranial pressure
O No O Yes
Q16 Current receipt of oxygen supplementation > 4 liters per minute O No O Yes
Q17 Current contact, droplet, or respiratory/airborne precautions O No O Yes
General comments
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Medical University of South Carolina, Data Coordination Unit
Form 117: Vitals Page 1 of 1 Version 1 (02-MAY-2019)
Sleep SMART Subject: └──┴──┴──┴──┴──┴──┘
Blood pressure recorded should be the blood pressure from chart as documented closest to 8 AM on day of consent. Subject’s height and weight should be based on chart abstraction closest to the date of hospital admission.
Qa Data collected O No O Yes
Q01 Systolic blood pressure ___________ mm Hg
Q02 Diastolic blood pressure ___________ mm Hg
Q03 Height ___________
Q04 Height units O in O cm
Q05 Weight ___________
Q06 Weight units O lb O kg
General comments
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Medical University of South Carolina, Data Coordination Unit
Form 106: Medical History Page 1 of 1 Version 1 (02-MAY-2019)
Sleep SMART Subject: └──┴──┴──┴──┴──┴──┘
Responses should be based on interview with subject and review of medical records. Use clinical judgement to determine responses.
Q01 Heart failure O No O Yes O Unknown
Q02 Stroke or transient ischemic attack
Prior to qualifying event.
O No O Yes O Unknown
Q03 Hypertension O No O Yes O Unknown
Q04 Peripheral arterial disease O No O Yes O Unknown
Q05 Ischemic heart disease
Angina Pectoris /PTCA /Myocardial Infarction /CABG
O No O Yes O Unknown
Q06 Diabetes mellitus O No O Yes O Unknown
Q07 Atrial fibrillation / Atrial flutter O No O Yes O Unknown
Q08 Hyperlipidemia O No O Yes O Unknown
Q09 Cancer
Excluding benign skin cancer
O No O Yes O Unknown
Q10 Sleep apnea O No O Yes O Unknown
Q11 Treated with a positive airway pressure device
Example: CPAP
O No O Yes O Unknown
Q12 If Q11 is ‘Yes’
Treated with a positive airway pressure device in the past month O No O Yes
Q13
Average number of hours of sleep during each 24-hour period for the month prior to enrolling stroke
Record the response to the nearest half-hour (e.g. 7.5)
______________ hours
General comments
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Medical University of South Carolina, Data Coordination Unit
Form 291: ABCD2
Page 1 of 1
Sleep SMART Subject: └──┴──┴──┴──┴──┴──┘
This form should be completed prior to randomization for subjects who do not have ongoing symptoms 24 hours after symptom onset, and whose imaging has not already indicated infarction.
Qa Data collected O No O Yes
Qb Date of assessment ___ ___ - ___ ___ ___ - ___ ___ ___ ___ dd-mmm-yyyy
Q01 Subject has TIA O No O Yes
Q02
If Q01 is ‘Yes’
Age ≥ 60 years old O (0) No O (1) Yes
Q03
Blood pressure
At initial acute evaluation
Systolic BP ≥ 140 mm Hg Or
Diastolic BP ≥ 90 mm Hg
O (0) No O (1) Yes
Q04 Clinical features of TIA
O (0) Neither speech impairment nor unilateral weakness
O (1) Speech impairment without weakness
O (2) Unilateral weakness
Q05 Diabetes
Past or current physician diagnosis
O (0) No O (1) Yes
Q06 Duration
O (0) TIA duration <10 min
O (1) TIA duration 10-59 min
O (2) TIA duration ≥60 min
Q07 Manually calculated score ____ (0-7)
Q08
Total score Derived by WebDCU.
Must be ≥ 4 for the subject to be eligible.
____ (0-7)
General comments
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e:
Medical University of South Carolina, Data Coordination Unit
Form 202: IQCODE— Proxy Only Page 1 of 4 Version 2 (8-OCT-2021)
Sleep SMART Subject: └──┴──┴──┴──┴──┴──┘
Qa Data collected O No O Yes
Qb Date of assessment ___ ___ - ___ ___ ___ - ___ ___ ___ ___ dd-mmm-yyyy
Compared with 10 years ago to just before the enrolling event, how was he/she at the following: The IQCODE must NOT be completed by the subject. It must be asked of an informant – a relative or friend – who has known the subject for at least 10 years.
Q01 Remembering things about family and friends (addresses, birthdates, jobs)
O 1 = Much improved
O 2 = A little improved
O 3 = No change
O 4 = A little worse
O 5 = Much worse
O 6 = Don’t Know
Q02 Remembering things that have happened recently
O 1 = Much improved
O 2 = A little improved
O 3 = No change
O 4 = A little worse
O 5 = Much worse
O 6 = Don’t Know
Q03 Recalling a conversation a few days later
O 1 = Much improved
O 2 = A little improved
O 3 = No change
O 4 = A little worse
O 5 = Much worse
O 6 = Don’t Know
Q04 Remembering his/her own address and telephone number
O 1 = Much improved
O 2 = A little improved
O 3 = No change
O 4 = A little worse
O 5 = Much worse
O 6 = Don’t Know
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Form 202: IQCODE— Proxy Only Page 2 of 4 Version 2 (8-OCT-2021)
Sleep SMART Subject: └──┴──┴──┴──┴──┴──┘
Q05 Remembering what day and month it is
O 1 = Much improved
O 2 = A little improved
O 3 = No change
O 4 = A little worse
O 5 = Much worse
O 6 = Don’t Know
Q06 Remembering where things are usually kept
O 1 = Much improved
O 2 = A little improved
O 3 = No change
O 4 = A little worse
O 5 = Much worse
O 6 = Don’t Know
Q07 Remembering where to find things which have been put in a different
place from usual
O 1 = Much improved
O 2 = A little improved
O 3 = No change
O 4 = A little worse
O 5 = Much worse
O 6 = Don’t Know
Q08 Knowing how to use familiar machines around the house
(telephone, washer)
O 1 = Much improved
O 2 = A little improved
O 3 = No change
O 4 = A little worse
O 5 = Much worse
O 6 = Don’t Know
Q09 Learning to use new machines around the house
(TV remote)
O 1 = Much improved
O 2 = A little improved
O 3 = No change
O 4 = A little worse
O 5 = Much worse
O 6 = Don’t Know
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e:
Medical University of South Carolina, Data Coordination Unit
Form 202: IQCODE— Proxy Only Page 3 of 4 Version 2 (8-OCT-2021)
Sleep SMART Subject: └──┴──┴──┴──┴──┴──┘
Q10 Learning new things in general
O 1 = Much improved
O 2 = A little improved
O 3 = No change
O 4 = A little worse
O 5 = Much worse
O 6 = Don’t Know
Q11 Following a story in a book or on TV
O 1 = Much improved
O 2 = A little improved
O 3 = No change
O 4 = A little worse
O 5 = Much worse
O 6 = Don’t Know
Q12 Making decisions on everyday matters
O 1 = Much improved
O 2 = A little improved
O 3 = No change
O 4 = A little worse
O 5 = Much worse
O 6 = Don’t Know
Q13 Handling money for shopping
O 1 = Much improved
O 2 = A little improved
O 3 = No change
O 4 = A little worse
O 5 = Much worse
O 6 = Don’t Know
Q14 Handling finances (pensions, banking)
O 1 = Much improved
O 2 = A little improved
O 3 = No change
O 4 = A little worse
O 5 = Much worse
O 6 = Don’t Know
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Form 202: IQCODE— Proxy Only Page 4 of 4 Version 2 (8-OCT-2021)
Sleep SMART Subject: └──┴──┴──┴──┴──┴──┘
Page 4 of 4
Q15 Handling other everyday math problems (quantities, distances)
O 1 = Much improved
O 2 = A little improved
O 3 = No change
O 4 = A little worse
O 5 = Much worse
O 6 = Don’t Know
Q16 Using his/her intelligence to understand what’s going on and reason
through things
O 1 = Much improved
O 2 = A little improved
O 3 = No change
O 4 = A little worse
O 5 = Much worse
O 6 = Don’t Know
Q17 Relationship to patient
O 1 = Spouse
O 2 = Child
O 3 = Brother or Sister
O 4 = Parent
O 5 = Other Family Member
O 6 = In-Law
O 7 = Friend, Neighbor
O 8 = Legal guardian, provider, etc.
O 9 = Other
General comments
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Form 144: Modified Rankin Scale Page 1 of 1 Version 2 (12 Aug 2021)
Sleep SMART Subject: └──┴──┴──┴──┴──┴──┘
Qa Data collected O No O Yes
Q01
Historical Modified Rankin Scale
The historical mRS should reflect the subject’s functioning prior to the enrolling event.
To be eligible, prior to the qualifying stroke/TIA, the patient must have been
able to perform his/her own basic ADLs. ADLs are considered to include toileting, feeding, dressing, grooming, ambulation, and bathing. The patient
must not require assistance from a person to perform these activities. Assistance can be physical, a reminder, or supervision required for safety.
Therefore, pre-stroke/TIA mRS should generally be 0-3.
O (0) No symptoms at all
O (1) No significant disability despite symptoms; able to
carry out all usual duties and activities
O (2) Slight disability; unable to carry out all previous
activities but able to look after own affairs without assistance.
O (3) Moderate disability requiring some help, but able to
walk without assistance.
O (4) Moderately severe disability; unable to walk without
assistance and unable to attend to own bodily needs without assistance.
O (5) Severe disability; bedridden, incontinent, and
requiring constant nursing care and attention.
General comments
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Form 501: STOP-BANG Page 1 of 1 Version 1 (02-MAY-2019)
Sleep SMART Subject: └──┴──┴──┴──┴──┴──┘
Qa Data collected O No O Yes
Qb Date of assessment ___ ___ - ___ ___ ___ - ___ ___ ___ ___ dd-mmm-yyyy
Please answer the following set of questions as you would have BEFORE the stroke or TIA that brought you to the hospital.
Q01 Do you snore loudly (louder than talking or loud enough to be
heard through closed doors)? O No O Yes
Q02 Do you often feel tired, fatigued, or sleepy during daytime? O No O Yes
Q03 Has anyone observed you stop breathing during your sleep? O No O Yes
Q04 Do you have or are you being treated for high blood pressure? O No O Yes
Q05 BMI more than 35 kg/m2? O No O Yes
Q06 Age over 50 year old?
Derived from Subject Enrollment Q06 O No O Yes
Q07 Do you know your neck circumference (or collar size) in inches? O No O Yes
Q08 If Q07 is
‘Yes’ Neck circumference (or collar size) in inches? ______ inches
Q09 If Q07 is ‘No’ Is your T-Shirt size large or greater?
O No
O Yes
O Unknown
Q10 Gender male?
Derived from Subject Enrollment Q03 O No O Yes
Q11 Respondent O Subject O Proxy
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Form 139: HADS-D Page 1 of 1
Sleep SMART Subject: └──┴──┴──┴──┴──┴──┘
Version 1 (02-MAY-2019)
Qa Data collected O No O Yes
Qb Date of assessment __ __ - __ __ __ - __ __ __ __ dd-mmm-yyyy
Instructions for Baseline assessment in reference to pre-stroke/TIA state: This questionnaire asks about your feelings prior to your stroke or TIA. Don’t take too long over your replies: your immediate reaction to each item will probably be more accurate than a long thought out response. Instructions for 3 and 6 month assessments: This questionnaire asks about your feelings. Don’t take too long over your replies: your immediate reaction to each item will probably be more accurate than a long thought out response.
Q01 I still enjoy the things I used to enjoy
O 0 = Definitely as much
O 1 = Not quite so much
O 2 = Only a little
O 3 = Not at all
Q02 I can laugh and see the funny side of things
O 0 = As much as I always could
O 1 = Not quite so much now
O 2 = Definitely not so much now
O 3 = Not at all
Q03 I feel cheerful
O 0 = Not at all
O 1 = Not often
O 2 = Sometimes
O 3 = Most of the time
Q04 I feel as if I am slowed down
O 0 = Nearly all the time
O 1 = Very Often
O 2 = Sometimes
O 3 = Not at all
Q05 I have lost interest in my appearance
O 0 = Definitely
O 1 = I don’t take as much care as I should
O 2 = I may not take quite as much care
O 3 = I take just as much care as ever
Q06 I look forward with enjoyment to things
O 0 = As much as I ever did
O 1 = Rather less than I used to
O 2 = Definitely less than I used to
O 3 = Hardly at all
Q07 I can enjoy a good book or radio or TV program
O 0 = Often
O 1 = Sometimes
O 2 = Not Often
O 3 = Very Seldom
General comments
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Form 241: Epworth Sleepiness Scale Page 1 of 1
Sleep SMART Subject: └──┴──┴──┴──┴──┴──┘
Qa Data collected O No O Yes
Qb Date of assessment ___ ___ - ___ ___ ___ - ___ ___ ___ ___ dd - mmm - yyyy
Instructions for Baseline assessment in reference to pre-stroke/TIA state: How likely were you to doze off or fall asleep in the following situations, in contrast to feeling just tired? This refers to your usual way of life in recent times prior to your stroke or TIA. Even if you have not done some of these things recently, try to work out how they would have affected you. Use the following scale to choose the most appropriate number for each situation. Instructions for 3 and 6 month assessments: How likely are you to doze off or fall asleep in the following situations, in contrast to feeling just tired? This refers to your usual way of life in recent times. Even if you have not done some of these things recently, try to work out how they would have affected you. Use the following scale to choose the most appropriate number for each situation.
Q01 Sitting and reading O 0 = would
never doze O 1 = slight
chance of dozing
O 2 =
moderate chance of dozing
O 3 = high
chance of dozing
Q02 Watching TV O 0 = would
never doze O 1 = slight
chance of dozing
O 2 =
moderate chance of dozing
O 3 = high
chance of dozing
Q03 Sitting, inactive in a public place (e.g. a
theater or meeting) O 0 = would
never doze O 1 = slight
chance of dozing
O 2 =
moderate chance of dozing
O 3 = high
chance of dozing
Q04 As a passenger in a car for an hour without a
break O 0 = would
never doze O 1 = slight
chance of dozing
O 2 =
moderate chance of dozing
O 3 = high
chance of dozing
Q05 Lying down to rest in the afternoon when
circumstances permit O 0 = would
never doze O 1 = slight
chance of dozing
O 2 =
moderate chance of dozing
O 3 = high
chance of dozing
Q06 Sitting and talking to someone O 0 = would
never doze O 1 = slight
chance of dozing
O 2 =
moderate chance of dozing
O 3 = high
chance of dozing
Q07 Sitting quietly after lunch without alcohol O 0 = would
never doze O 1 = slight
chance of dozing
O 2 =
moderate chance of dozing
O 3 = high
chance of dozing
Q08 In a car, while stopped for a few minutes in
the traffic O 0 = would
never doze O 1 = slight
chance of dozing
O 2 =
moderate chance of dozing
O 3 = high
chance of dozing
Q09 Respondent O Subject O Proxy
General comments
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Medical University of South Carolina, Data Coordination Unit
Form 143: NIH Stroke Scale Page 1 of 3
Sleep SMART Subject: └──┴──┴──┴──┴──┴──┘
Version 2 (12-Sept-2021)
Qa Data collected O No O Yes
Qb Date of assessment ___ ___ - ___ ___ ___ - ___ ___ ___ ___ dd-mmm-yyyy
Q1a Level of Consciousness
O 0 = Alert; keenly responsive
O 1 = Not alert, but arousable by minor stimulation to obey, answer or respond
O 2 = Not alert, requires repeated stimulation to attend, or is obtunded and requires
strong or painful stimulation to make movements (not stereotyped)
O 3 = Responds only with reflex motor or autonomic effects or totally unresponsive,
flaccid, and areflexic
Q1b LOC Questions
O 0 = Answers both questions correctly
O 1 = Answers one question correctly
O 2 = Answers neither question correctly
Q1c LOC Commands
O 0 = Performs both tasks correctly
O 1 = Performs one task correctly
O 2 = Performs neither task correctly
Q2 Best Gaze
O 0 = Normal
O 1 = Partial gaze palsy; gaze is abnormal in one or both eyes, but forced deviation or
total gaze paresis is not present
O 2 = Forced deviation, or total gaze paresis not overcome by the oculocephalic
maneuver
Q3 Visual
O 0 = No visual loss
O 1 = Partial hemianopia
O 2 = Complete hemianopia
O 3 = Bilateral hemianopia (blind including cortical blindness)
Q4
Facial Palsy
O 0 = Normal symmetrical movement
O 1 = Minor paralysis (flattened nasolabial fold, asymmetry on smiling)
O 2 = Partial paralysis (total or near total paralysis of lower face)
O 3 = Complete paralysis of one or both sides (absence of facial movement in the upper
and lower face)
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Medical University of South Carolina, Data Coordination Unit
Form 143: NIH Stroke Scale Page 2 of 3
Sleep SMART Subject: └──┴──┴──┴──┴──┴──┘
Version 2 (12-Sept-2021)
Q5a Motor Arm Left
O 0 = No drift, limb holds 90 (or 45) degrees for full 10 seconds
O 1 = Drift, limb holds 90 (or 45) degrees, but drifts down before full 10 seconds; does not hit bed or
other support
O 2 = Some effort against gravity, limb cannot get to or maintain (if cued) 90 (or 45) degrees, drifts
down to bed, but has some effort against gravity
O 3 = No effort against gravity, limb falls
O 4 = No movement
O UN= Amputation or joint fusion
Q5aT Motor Arm Left
untestable explain
Q5b Motor Arm Right
O 0 = No drift, limb holds 90 (or 45) degrees for full 10 seconds
O 1 = Drift, limb holds 90 (or 45) degrees, but drifts down before full 10 seconds; does not hit bed or
other support
O 2 = Some effort against gravity, limb cannot get to or maintain (if cued) 90 (or 45) degrees, drifts
down to bed, but has some effort against gravity
O 3 = No effort against gravity, limb falls
O 4 = No movement
O UN= Amputation or joint fusion
Q5bT Motor Arm Right
untestable explain
Q6a Motor Leg Left
O 0 = No drift, leg holds 30 degrees position for full 5 seconds
O 1 = Drift, leg falls by the end of the 5 second period but does not hit bed
O 2 = Some effort against gravity; leg falls to bed by 5 seconds, but has some effort against gravity
O 3 = No effort against gravity; leg falls to bed immediately
O 4 = No movement
O UN= Amputation or joint fusion
Q6aT Motor Leg Left
untestable explain
Q6b Motor Leg Right
O 0 = No drift, leg holds 30 degrees position for full 5 seconds
O 1 = Drift, leg falls by the end of the 5 second period but does not hit bed
O 2 = Some effort against gravity; leg falls to bed by 5 seconds, but has some effort against gravity
O 3 = No effort against gravity; leg falls to bed immediately
O 4 = No movement
O UN= Amputation or joint fusion
Q6bT Motor Leg Right
untestable explain
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Medical University of South Carolina, Data Coordination Unit
Form 143: NIH Stroke Scale Page 3 of 3
Sleep SMART Subject: └──┴──┴──┴──┴──┴──┘
Version 2 (12-Sept-2021)
Q7 Limb Ataxia
O 0 = Absent
O 1 = Present in one limb
O 2 = Present in two limbs
O UN= Amputation or joint fusion
Q7T Limb Ataxia
untestable explain
Q8 Sensory
O 0 = Normal; no sensory loss
O 1 = Mild to moderate sensory loss; patient feels pinprick is less sharp or is dull on the affected side;
or there is a loss of superficial pain with pinprick, but patient is aware of being touched
O 2 = Severe to total sensory loss; patient is not aware of being touched in the face, arm and leg
Q9 Best Language
O 0 = No aphasia, normal
O 1 = Mild to moderate aphasia; some obvious loss of fluency or facility of comprehension, without
significant limitation on ideas expressed or form of expression. Reduction of speech and/or comprehension, however, makes conversation about provided materials difficult or impossible. For example, in conversation about provided materials, examiner can identify picture or naming card content from patient’s response
O 2 = Severe aphasia; all communication is through fragmentary expression; great need for inference,
questioning, and guessing by the listener. Range of information that can be exchanged is limited; listener carries burden of communication. Examiner cannot identify materials provided from patient response
O 3 = Mute, global aphasia; no usable speech or auditory comprehension
Q10 Dysarthria
O 0 = Normal
O 1 = Mild to moderate dysarthria; patient slurs at least some words and, at worst, can be understood
with some difficulty
O 2 = Severe dysarthria; patient’s speech is so slurred as to be unintelligible in the absence of or out
of proportion to any dysphasia, or is mute/anarthric
O UN= Intubated or other physical barrier
Q10T Dysarthria
untestable explain
Q11
Extinction and Inattention
Formerly Neglect.
O 0 = No abnormality
O 1 = Visual, tactile, auditory, spatial, or personal inattention or extinction to bilateral simultaneous
stimulation in one of the sensory modalities
O 2 = Profound hemi-inattention or extinction to more than one modality; does not recognize own hand
or orients to only one side of space
Q12 Assessor calculated
total score __ __
Q13 NIHSS total score
Derived by WebDCU. __ __
Qd1 Assessor first name └──┴──┴──┴──┴──┴──┴──┴──┴──┴──┴──┴──┴──┴──┴──┘
Qd2 Assessor last name └──┴──┴──┴──┴──┴──┴──┴──┴──┴──┴──┴──┴──┴──┴──┘
General comments
Visit: Baseline
If this is a source document, sign and date: ___________________________________________
Signature
__ __-__ __ __ - __ __ __ __
dd-mmm-yyyy
_______________________________
Print name Sourc
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Medical University of South Carolina, Data Coordination Unit
Form 143: NIH Stroke Scale Page 4 of 3
Sleep SMART Subject: └──┴──┴──┴──┴──┴──┘
Version 2 (12-Sept-2021)
Visit: Baseline
If this is a source document, sign and date: ___________________________________________
Signature
__ __-__ __ __ - __ __ __ __
dd-mmm-yyyy
_______________________________
Print name Sourc
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Medical University of South Carolina, Data Coordination Unit
Form 143: NIH Stroke Scale Page 5 of 3
Sleep SMART Subject: └──┴──┴──┴──┴──┴──┘
Version 2 (12-Sept-2021)
Visit: Baseline
If this is a source document, sign and date: ___________________________________________
Signature
__ __-__ __ __ - __ __ __ __
dd-mmm-yyyy
_______________________________
Print name Sourc
e: N
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Medical University of South Carolina, Data Coordination Unit
Form 143: NIH Stroke Scale Page 6 of 3
Sleep SMART Subject: └──┴──┴──┴──┴──┴──┘
Version 2 (12-Sept-2021)
Visit: Baseline
If this is a source document, sign and date: ___________________________________________
Signature
__ __-__ __ __ - __ __ __ __
dd-mmm-yyyy
_______________________________
Print name Sourc
e: N
IHS
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Medical University of South Carolina, Data Coordination Unit
Form 143: NIH Stroke Scale Page 7 of 3
Sleep SMART Subject: └──┴──┴──┴──┴──┴──┘
Version 2 (12-Sept-2021)
Visit: Baseline
If this is a source document, sign and date: ___________________________________________
Signature
__ __-__ __ __ - __ __ __ __
dd-mmm-yyyy
_______________________________
Print name
Medical University of South Carolina, Data Coordination Unit
Form 506: aCPAP Run-In Night Page 1 of 1 Version 4 (28-JUL-2021)
Sleep SMART Subject: └──┴──┴──┴──┴──┴──┘
Q01
Run-in night conducted
Conducted is defined as aCPAP device turned on and applied to subject, irrespective of the duration of aCPAP use.
O No O Yes
Q02
If Q01 is ‘No’
Reason aCPAP run-in night not performed
A subject refusing to participate in either the Nox T3 or run-in night, including due to mask fit, should be marked as
’Subject declined to attempt run-in night’.
O Nox T3 attempted, but no results
O Nox T3 results show AHI less than 10 or CAI greater
than 50% of AHI
O Subject declined to attempt run-in night
O Subject discharged prior to ability to perform run-in
O Other
Q02T Specify reason aCPAP run-in night not conducted
Q09 If Q01 is
‘Yes’
Run-in night was repeated
Final run-in night should be the one reported in Q03-Q08. O No O Yes
Q10 If Q09 is
‘Yes’
Initial run-in night was interrupted by clinical activity
Interruption by clinical activity means that the initial aCPAP run-in night was interrupted and limited by clinical care or
was poorly tolerated because of a specific situation that will not likely re-occur, and for this reason does not meet the ≥4-
hour criterion.
O No O Yes
Q03 If Q01 is
‘Yes’
Date of run-in night
Final run-in night if more than one.
___ ___ - ___ ___ ___ - ___ ___ ___ ___ dd-mmm-yyyy
Q04
If Q01 is ‘Yes’
PAP device usage
PAP device reading for ‘Usage Hours’ on morning after run-in night (total hours of use).
______________ hours
Q05
PAP device pressure
PAP device ‘Pressure’ reading (95th percentile pressure administered) on morning after run-in night.
______________ cmH2o
Q06
PAP device leak
PAP device ‘Leak’ reading (95th percentile leak) on morning after run-in night.
______________ L/min
Q07 PAP device AHI
PAP device ‘AHI’ reading on morning after run-in night.
_______________
Q08 PAP device central AI
PAP device ‘Central AI’ reading on morning after run-in night.
_______________
General comments
Visit: Baseline
If this is a source document, sign and date: ___________________________________________
Signature
__ __-__ __ __ - __ __ __ __
dd-mmm-yyyy
_______________________________
Print name
Medical University of South Carolina, Data Coordination Unit
Form 104: Adverse Event Page 1 of 2 Version 5 (25-SEP-2021)
Sleep SMART Subject: └──┴──┴──┴──┴──┴──┘
This CRF is optional and should only be completed if the subject experiences a reportable Adverse Event. Reportable AEs include:
Between the time of consent and randomization, sites need only to report clinical outcome events, all SAEs deemed by the site to be possibly or definitely related to the T3 sleep apnea test or aCPAP run-in, and AEs of special interest that are deemed by the site to be possibly or definitely related to the T3 sleep apnea test or aCPAP run-in. Between randomization and end of the subject’s participation in the study, all SAEs, clinical outcomes, and AEs of special interest must be reported by the clinical site investigator. Note that newly discovered atrial fibrillation is considered an SAE even if no treatment is rendered. Additionally, a chronic medical condition (e.g. carotid stenosis) resulting in a significant procedure (e.g. carotid stenting) that has a risk of causing serious morbidity should be reported as an SAE.
Clinical outcomes include ischemic stroke, hemorrhagic stroke, and acute coronary syndrome.
AEs of special interest include pneumonia, respiratory failure, pneumothorax, car crashes or other physical injury related to sleepiness, skin infection on face caused by CPAP mask that requires treatment, and positive PCR test for COVID-19.
Q01 Adverse Event Name
Brief description of the event
LLT AE MedDRA Term
Refer to Common Terminology Criteria for Adverse Events (CTCAE). The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline:
Grade 1 - Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.
Grade 2 - Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living.
Grade 3 - Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting
self care Activities of Daily Living.
Grade 4 - Life-threatening consequences; urgent intervention indicated.
Grade 5 - Death related to AE.
Q02 Grade
O Grade 1
O Grade 2
O Grade 3
O Grade 4
O Grade 5
Q03 Serious O No O Yes
Q04 Relatedness to study intervention
O Unrelated
O Unlikely
O Reasonable possibility
O Definitely
Q05 Date of onset ___ ___ - ___ ___ ___ - ___ ___ ___ ___ dd-mmm-yyyy
Q07 Outcome
O Resolved
O Resolved w/ sequelae
O Continuing (Follow up is required)
O Continuing at end of study (No follow up is required)
O Continuing at time of death
O Unknown
Q08
If Q07 is ‘Resolved’ or ‘Resolved w/
sequelae’
Date of resolution ___ ___ - ___ ___ ___ - ___ ___ ___ ___ dd-mmm-yyyy
Visit: Baseline
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Signature
__ __-__ __ __ - __ __ __ __
dd-mmm-yyyy
_______________________________
Print name
Medical University of South Carolina, Data Coordination Unit
Form 104: Adverse Event Page 2 of 2 Version 5 (25-SEP-2021)
Sleep SMART Subject: └──┴──┴──┴──┴──┴──┘
Q12
Type of event
Acute coronary syndrome is unstable angina, non-ST segment elevation MI, and ST-segment elevation MI defined by ECG, diagnostic biomarker, and cardiac
symptoms or signs.
O Ischemic Stroke
O Hemorrhagic stroke
O Acute coronary syndrome
O Pneumonia
O Respiratory failure
O Pneumothorax
O Car crashes or other physical injury related to sleepiness
O Skin infection on face caused by CPAP mask that
requires treatment
O Other AE/SAE
Q13 Date of first knowledge of event __ __ - __ __ __ - __ __ __ __ dd-mmm-yyyy
Q21 O No
COVID-19 diagnosis with positive PCR test associated with this event
Includes symptomatic and asymptomatic O Yes
Q15
Describe the event or problem
If pneumonia, then include the likelihood of aspiration.
If increased intracranial pressure, include any treatment given and if the subject was transferred to ICU.
If physical injury due to car crash, describe how it was related to subject’s
sleepiness.
Indicate if a hemicraniectomy/suboccipital craniectomy was performed for the event.
Q16 Relevant tests / laboratory data, including dates
Q17 Other relevant history, including pre-existing medical conditions
Q18 Last name of reporting site investigator
Q19 Date of reporting site investigator signature ___ ___ - ___ ___ ___ - ___ ___ ___ ___ dd-mmm-yyyy
Q20
If Q12 is ‘Pneumonia’ or
‘Respiratory failure’
Intubated due to an AE O No O Yes
General comments
Visit: Baseline
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