Clinical trial NCT06029959: Stroke and CPAP Outcome Study 3
Official title: Optimizing Adherence to the Treatment of Sleep Apnea Among Patients With Stroke Undergoing Inpatient Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Intra Cerebral Hemorrhage
Obstructive Sleep Apnea
Adherence, Treatment
Motivation
Keywords: behavioral therapy
continuous positive airway pressure
rehabilitation therapy
stroke recovery
self determination
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-09-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: In an initial single-arm study, participants with stroke will be tested for OSA and treated with auto-titrating CPAP during inpatient stroke rehabilitation and continued for a 3-month treatment period. Multiple behavioral interventions will be used to improve CPAP use, including intensive CPAP technical support, motivational enhancement therapy, and phone and mobile health automated support. The multicomponent behavioral intervention will be optimized to improve CPAP adherence with the engagement and input of stroke survivors.

Eligibility criteria: 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

Primary outcomes:
measure: CPAP Adherence
timeFrame: From CPAP initiation after study enrollment and sleep apnea testing to 90 days from CPAP initiation
Secondary outcomes:
measure: Stroke Severity
timeFrame: From in-person assessment at enrollment to the end of inpatient rehabilitation
measure: Functional Disability
timeFrame: From in-person assessment at enrollment to follow-up timepoint of 90 +/- 14 days after enrollment
Other outcomes:
measure: CPAP partner burden
timeFrame: At follow-up timepoint of 90 +/- 14 days after enrollment
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Sandeep Khot, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Devin Brown, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: