Actively Recruiting
Optimizing Adherence to the Treatment of Sleep Apnea Among Patients With Stroke Undergoing Inpatient Rehabilitation
Led by University of Washington · Updated on 2026-03-30
250
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of an intensive support program for Continuous Positive Airway Pressure (CPAP) therapy compared to usual care in stroke patients who have obstructive sleep apnea (OSA) during inpatient rehabilitation. This multicenter randomized controlled trial involves about 250 participants recruited over approximately three years from two inpatient rehabilitation centers. The study aims to see if the intensive support program improves CPAP use and stroke recovery as measured by adherence and the modified Rankin Scale. Participants with OSA are randomly assigned to either an Intensive Support group or a Standard Support group. The Intensive Support group receives a multicomponent behavioral adherence program including CPAP technical support, Motivational Enhancement Therapy, a mobile health app called myAir, tailored text messaging, and educational materials. Both groups receive basic supportive treatments such as CPAP education, respiratory therapy, nursing support during rehabilitation, and referral to durable medical equipment companies as needed. CPAP therapy is started during inpatient rehabilitation and is continued for three months. During the study, CPAP use is electronically measured to track average nightly use over the 90-day period. Stroke recovery is evaluated with the Modified Rankin Scale at three months by phone. Participants receive monthly phone follow-ups for adherence support, and researchers monitor CPAP use, recovery, and safety outcomes. The total participation includes inpatient rehabilitation and a three-month treatment period with ongoing assessments.
CONDITIONS
Brief Title
Stroke and CPAP Outcome Study 3 Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Acute ischemic infarction or intraparenchymal hemorrhage confirmed by head CT or brain MRI within the past 30 days
- Ability to provide consent in English or Spanish, either by the patient or legally authorized representative
You will not qualify if you...
- Unable to obtain informed consent in English or Spanish from participant or legally authorized representative
- Incarcerated individuals
- Known pregnancy
- Current mechanical ventilation, tracheostomy, or supplemental oxygen use over 4 liters per minute
- Use of positive airway pressure within 14 days prior to stroke
- History of pneumothorax, bullous emphysema, or other serious conditions limiting CPAP use
- Stroke caused by tumors, vascular malformations, or subarachnoid hemorrhage
- Active use of sedative drugs interfering with sleep apnea testing within 48 hours prior to sleep study
- Anticipated inpatient rehabilitation length of stay less than 5 nights
- Co-morbid conditions limiting sleep apnea testing or CPAP use as judged by study team
- Recent cranial or spinal surgery with possible cerebrospinal fluid leak within past 3 months
- Significant risk of aspiration making CPAP use unsafe as determined by site principal investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - Up to 30 days prior to inpatient rehabilitation admission
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for sleep apnea testing
Duration - Inpatient rehabilitation stay (minimum 5 nights)
Participants start using an automatically-adjusting CPAP device during inpatient rehabilitation with technical support, mask fitting, and training provided by study staff.
Daily support visits during inpatient rehabilitation
Duration - 3 months
Participants continue CPAP use at home for 3 months, receiving behavioral adherence support including motivational therapy, tailored messages, phone follow-ups, and access to a self-tracking app.
Monthly phone calls and ongoing remote support; additional sessions as needed
Duration - At 3 months
Participants are assessed for stroke recovery and CPAP adherence approximately 3 months after starting treatment, primarily through phone contact.
1 follow-up phone visit
Trial Site Locations
Total: 2 locations
1
Rancho Research Institute
Downey, California, United States, 90242
Actively Recruiting
2
University of Washington - Harborview Medical Center
Seattle, Washington, United States, 98104
Actively Recruiting
Research Team
M
Morgan Aurelio, DNP, MPH, ARNP-CNM
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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