The Recovery in Stroke Using PAP Study

NCT04130503 | Recruiting DMC FDA Device

• 2 other identifiers: 20000245121R01NR018335-01
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study is a randomized controlled trial among an anicipated 180 participants with acute ischemic stroke and mod/severe OSA diagnosed by ambulatory polysomnography (PSG) comparing PAP treatment with usual care concerning the primary outcome of functional recovery.

Conditions

Ischemic Stroke; Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (2)

• Modified Rankin Scale (mRS)

  The Modified Rankin Scale is a widely used measure of functional status and is sensitive to the full range of impairment from mild to severe. This objective examination scale with be video recorded by field staff and subsequently scored by the study neurologist blinded to randomization arm. The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 6. The higher the score, the more severe the disability. A score of 6 indicates the patient has expired (during the hospital stay or after discharge from the hospital).

  6 months

• Change in Katz Scale

  The Katz Index of Independence in Activities of Daily Living (KatzADL), is the most appropriate instrument to assess functional status as a measurement of the client's ability to perform Activities of Daily Living independently. The Index ranks adequacy of performance in the 6 functions of bathing, dressing, toileting, transferring, continence, and feeding. Clients are scored yes/no for independence in each of the 6 functions. A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment

  Randomization date, 3 months, 6 months

Secondary Outcomes (17)

• NIH Stroke Scale (NIHSS)

  1 month

• NIH Stroke Scale (NIHSS)

  3 months

• Epworth Sleepiness Scale (ESS)

  6 months

• Medical Outcomes Survey-Short Form 36 (MOS-SF36)

  6 months

• Patient Health Questionnaire-8 (PHQ-8)

  6 months

Study Arms (4)

PAP treatment- Acute

EXPERIMENTAL

Acute intervention patients will start PAP within 1-week poststroke symptom onset, and subacute patients will start PAP 1-month post-symptom onset. Both groups will continue PAP therapy through the duration of the study, reinforced with technical assistance and behavioral support. All patients (randomized and non-randomized) will receive a healthy lifestyle education (HLE) intervention focused on secondary stroke prevention, as well as interim contacts occurring at 1 week, 1 month, and 3 months, post-randomization, where outcome measures and safety assessments will occur.

Device: PAP; Behavioral: HLE

Usual Care (HLE)

ACTIVE COMPARATOR

All patients (randomized and non-randomized) will receive a healthy lifestyle education (HLE) intervention focused on secondary stroke prevention, as well as interim contacts occurring at 1 week, 1 month, and 3 months, post-randomization, where outcome measures and safety assessments will occur.

Behavioral: HLE

PAP treatment- Subacute

EXPERIMENTAL

Acute intervention patients will start PAP within 1-week poststroke symptom onset, and subacute patients will start PAP 1-month post-symptom onset. Both groups will continue PAP therapy through the duration of the study, reinforced with technical assistance and behavioral support. All patients (randomized and non-randomized) will receive a healthy lifestyle education (HLE) intervention focused on secondary stroke prevention, as well as interim contacts occurring at 1 week, 1 month, and 3 months, post-randomization, where outcome measures and safety assessments will occur.

Device: PAP; Behavioral: HLE

Exploratory arm

OTHER

Non-randomized comparison/exploratory group of subjects with ischemic stroke and Apnea-Hypopnea Index (AHI) \<15 (approximately 120 participants) and approximately 60 subjects with ICH (who do not need legally authorized representative for consent - most likely mild form of ICH) and any level of AHI.

Behavioral: HLE

Interventions

PAP DEVICE

Positive airway pressure (PAP) treatment of obstructive sleep apnea (OSA).

PAP treatment- Acute; PAP treatment- Subacute

HLE BEHAVIORAL

All patients (randomized and non-randomized) will receive a healthy lifestyle education (HLE) intervention focused on secondary stroke prevention.

Exploratory arm; PAP treatment- Acute; PAP treatment- Subacute; Usual Care (HLE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having an acute ischemic stroke with brain imaging within 48 hours of symptoms onset;
• Being within 5 days of neurologic symptoms onset;
• Moderate (15 =\< overall AHI \< 30) /severe (overall AHI \>= 30) OSA, thus with an obstructive apnea-hypopnea index AHI \>= 15.

You may not qualify if:

• Past use of prescribed PAP for OSA;
• Suspected sleep disorder other than OSA (e.g., narcolepsy) (because such patients should be referred for a formal PSG in a sleep laboratory);
• Life expectancy is less than 6 months (e.g., hospice patients);
• Patients who require mechanical ventilation (because such patients could not participate in the intervention protocol);
• Non-English language patients (because the intervention strategy involves forming a relationship between the patient and research staff);
• Central sleep apnea with \> 50% of respiratory events classified as central apnea;
• Resting oxygen saturation \< 90%.
• Inability to provide their own informed consent. To enhance the generalizability of our study, all stroke severity will be included. However, we will exclude patients who cannot provide their own consent. This is because patients will need to participate actively in the protocol with a behavioral intervention. An assessment of the patient's competence to provide consent will be made based on published recommendations.

Sponsors & Collaborators

• Yale University: lead
• Hartford HealthCare: collaborator
• National Institute of Nursing Research (NINR): collaborator
• American Academy of Sleep Medicine Foundation (AASM): collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06519, United States

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Study Officials

• Klar Yaggi, MD, MPH

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Radu Radulescu, MD

CONTACT

2033614037; radu.radulescu@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to usual care or PAP- acute and subacute patients will receive different PAP treatments (non-randomized).

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 17, 2019
• Study Start: September 1, 2019
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)