The Recovery in Stroke Using PAP Study (RISE-UP)

Yale University

Status: Enrolling

Conditions: Ischemic Stroke; Obstructive Sleep Apnea

Treatments: Behavioral: HLE; Device: PAP

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04130503

1R01NR018335-01 (U.S. NIH Grant/Contract)

2000024512

Details and patient eligibility

About

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.

Full description

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

Specific aim 1 or Aim A: 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 or Aim D: 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 or Aim B: 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 or Aim C: Evaluate whether polysomnographic measures have prognostic utility in understanding the variability in stroke recovery.

With regard to projected recruitment scenarios, investigators will use an appropriate Aim scenario as described below:

In case of low post-randomization losses with symmetrical distribution between mild and no OSA/SAS (sleep apnea syndrome) and more severe OSA/SAS - Aims labeled with numbers will be used.

In case of high post randomization losses with asymmetrical distribution between mild and no OSA/SAS (sleep apnea syndrome) and more severe OSA/SAS - the same Aims labeled with letters will be used.

Enrollment: 360 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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360 participants in 4 patient groups

PAP treatment- Acute

Experimental group

Description:

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.

Treatment:

Behavioral: HLE

Device: PAP

Usual Care (HLE)

Active Comparator group

Description:

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.

Treatment:

Behavioral: HLE

PAP treatment- Subacute

Experimental group

Description:

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.

Treatment:

Behavioral: HLE

Device: PAP

Exploratory arm

Other group

Description:

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.

Treatment:

Behavioral: HLE