Obstructive Sleep Apnea Clinical Trial
— SCOUTS3Official title:
Optimizing Adherence to the Treatment of Sleep Apnea Among Patients With Stroke Undergoing Inpatient Rehabilitation
A problem with breathing during sleep, called obstructive sleep apnea (OSA), likely increases the risk of stroke and is common in people who have had a stroke, present in about 2/3 of stroke survivors. There is also evidence that OSA predicts worse outcome after stroke. The question being addressed in the Stroke and CPAP Outcome Study 3 (SCOUTS3) is how to improve use of continuous positive airway pressure (CPAP) therapy to treat OSA when started during intensive stroke rehabilitation.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | June 30, 2028 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age 18 years or older - Head CT or brain MRI demonstrating an acute ischemic infarction or intraparenchymal hemorrhage within past 30 days - Person providing consent (patient or legally authorized representative) able to be consented in English or Spanish Exclusion Criteria: - Unable to obtain informed consent from participant or surrogate - Incarcerated - Known pregnancy - Current mechanical ventilation, tracheostomy or supplemental oxygen use > 4L/min - Current use of positive airway pressure or use within 14 days prior to stroke - History of pneumothorax, bullous emphysema or other serious co-morbid conditions which limit CPAP use - Stroke related to tumors, vascular malformations or subarachnoid hemorrhage - Active use of sedative drugs that can interfere with testing for obstructive sleep apnea (OSA) - Anticipated inpatient rehabilitation length of stay < 3 nights |
Country | Name | City | State |
---|---|---|---|
United States | University of Washington | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | CPAP partner burden | Zarit Burden Interview (ZBI) [range 0-28; higher scores indicate greater caregiver burden] | At follow-up timepoint of 90 +/- 14 days after enrollment | |
Primary | CPAP Adherence | Mean hours of nightly CPAP use during and after inpatient rehabilitation over 3 months | From CPAP initiation after study enrollment and sleep apnea testing to 90 days from CPAP initiation | |
Secondary | Stroke Severity | National Institutes of Health Stroke Scale (NIHSS) [range 0-42; higher scores indicate greater neurologic impairment] | From in-person assessment at enrollment to the end of inpatient rehabilitation | |
Secondary | Functional Disability | Modified Rankin Score-9 Questions (mRS-9Q) [range 0-5; higher scores indicate lower level of function in neurological disease] | From in-person assessment at enrollment to follow-up timepoint of 90 +/- 14 days after enrollment |
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