Clinical trial NCT04130503: The Recovery in Stroke Using PAP Study
Official title: The Recovery in Stroke Using PAP Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic Stroke
Obstructive Sleep Apnea
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Hartford HealthCare
First posted: 2019-10-17
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to usual care or PAP- acute and subacute patients will receive different PAP treatments (non-randomized).
Primary purpose: TREATMENT

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.

Detailed description: This study has 4 aims: 3 main aims and an additional exploratory aim.

Specific aim 1: Test whether PAP treatment for OSA in ischemic stroke improves stroke severity, post-stroke symptoms, post-stroke functional recovery (primary outcome), and quality of life.

Specific aim 2: Determine whether acute vs. subacute initiation of PAP in ischemic stroke results in greater improvement in post-stroke outcomes (stroke severity, symptoms, stroke recovery, quality of life).

Specific Aim 3: Conduct in-depth qualitative interviews with 25-30 stroke patients, family members, and acute care providers to elicit their experience with PAP use, including factors that influence adherence.

Exploratory aim: Evaluate whether polysomnographic measures have prognostic utility in understanding the variability in stroke recovery.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Modified Rankin Scale (mRS)
timeFrame: 6 months
measure: Change in Katz Scale
timeFrame: Randomization date, 3 months, 6 months
Secondary outcomes:
measure: NIH Stroke Scale (NIHSS)
timeFrame: 1 month
measure: NIH Stroke Scale (NIHSS)
timeFrame: 3 months
measure: Epworth Sleepiness Scale (ESS)
timeFrame: 6 months
measure: Medical Outcomes Survey-Short Form 36 (MOS-SF36)
timeFrame: 6 months
measure: Patient Health Questionnaire-8 (PHQ-8)
timeFrame: 6 months
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 6 months
measure: Stroke Specific Quality of Life (SS-QOL)
timeFrame: 6 months
measure: The Calgary Sleep Apnea Quality of Life Index (SAQLI)
timeFrame: 6 months
measure: Formative Adherence Evaluation
timeFrame: 3 months
measure: Change in Berg Balance Scale
timeFrame: 3 and 6 months
measure: Fall Events
timeFrame: Up to 6 months
measure: Change in Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Randomization date, 3 months, 6 months
measure: Change in Insomnia Severity Index (ISI) Severity Index
timeFrame: Randomization date, 3 months, 6 months
measure: Change in PROMIS Pain Interference - Short Form 6b V1.0
timeFrame: Randomization date, 3 months, 6 months
measure: Change in PROMIS Pain Intensity - Short Form 3a V1.0
timeFrame: Randomization date, 3 months, 6 months
measure: Change in PROMIS Short Form v1.0 Sleep Disturbance 8a
timeFrame: day 7
measure: Change in PROMIS Short Form v1.0 Sleep-Related Impairment 8a
timeFrame: day 7
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Klar Yaggi, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: