The Recovery in Stroke Using PAP Study

Overview

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 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.

Interventions

• Device PAP
  Positive airway pressure (PAP) treatment of obstructive sleep apnea (OSA).
• Behavioral HLE
  All patients (randomized and non-randomized) will receive a healthy lifestyle education (HLE) intervention focused on secondary stroke prevention.

Primary outcome measures

• Modified Rankin Scale (mRS) [Time frame: 6 months]
• Change in Katz Scale [Time frame: Randomization date, 3 months, 6 months]

Secondary outcome measures (12)

• NIH Stroke Scale (NIHSS) [Time frame: 1 month]
• NIH Stroke Scale (NIHSS) [Time frame: 3 months]
• Epworth Sleepiness Scale (ESS) [Time frame: 6 months]
• Medical Outcomes Survey-Short Form 36 (MOS-SF36) [Time frame: 6 months]
• Patient Health Questionnaire-8 (PHQ-8) [Time frame: 6 months]
• Montreal Cognitive Assessment (MoCA) [Time frame: 6 months]
• Stroke Specific Quality of Life (SS-QOL) [Time frame: 6 months]
• The Calgary Sleep Apnea Quality of Life Index (SAQLI) [Time frame: 6 months]
• Formative Adherence Evaluation [Time frame: 3 months]
• Change in Berg Balance Scale [Time frame: 3 and 6 months]
• Fall Events [Time frame: Up to 6 months]
• Change in Pittsburgh Sleep Quality Index (PSQI) [Time frame: Randomization date, 3 months, 6 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Yale University — New Haven

Identifiers

NCT: NCT04130503 · 2000024512 · 1R01NR018335-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗