Stroke and CPAP Outcome Study 3

Obstructive Sleep Apnea Clinical Trial

— SCOUTS3  

Official title:

Optimizing Adherence to the Treatment of Sleep Apnea Among Patients With Stroke Undergoing Inpatient Rehabilitation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06029959
• Other study ID #: STUDY00016907
• Secondary ID: 1R01HL164394-01A
• Status: Recruiting
• Phase: N/A
• Start date: September 28, 2023
• Est. completion date: June 30, 2028

Study information

• Verified date: November 2023
• Source: University of Washington
• Contact: Sandeep Khot, MD, MPH
• Phone: 206-744-3251
• Email: skhot[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Adherence, Treatment
• Cerebral Hemorrhage
• Hemorrhage
• Intra Cerebral Hemorrhage
• Ischemic Stroke
• Motivation
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Stroke

Intervention

Device:
• Continuous positive airway pressure (CPAP)
Eligible participants with a diagnosis of OSA will be set up with autotitrating CPAP by the study's sleep technologist. The CPAP device includes an auto-titrator that adjusts the delivered pressure between 5 to 15 cm of water to eliminate obstructive events.

Behavioral:
• CPAP technical support intervention
SCOUTS 3 sleep technologists (ST) will make mask type/size or device adjustments, as needed, and provide training to participants and CPAP partners to improve skills involved with mask placement and device maintenance. For participants with non-acceptance of CPAP over the first night, a standardized desensitization program will be implemented. Persistent problems with CPAP use or mask fit, or any high residual respiratory events will be discussed between the sleep technologist and the study's board-certified sleep medicine physician.
• Motivational Enhancement Therapy (MET)
In-person Motivational Enhancement Therapy (MET) sessions by a trained sleep coach will occur within a week of starting CPAP and, with permission, conducted with a CPAP partner, when available. The MET session recordings will be uploaded into the HIPAA compliant Lyssn platform for evaluation, including feedback to the sleep coach. The goal will be 5 total MET sessions, either in-person or by phone, spanning the inpatient and then outpatient settings.
• Mobile Health intervention
Study participants will be assisted in registering for and trained on the ResMed myAir app. Participants will also receive mobile health messages based on Self-Determination Theory.

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   NIH Reporter