RECRUITING

Stroke and CPAP Outcome Study 3 Randomized Controlled Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The SCOUTS 3 study aims to test the effectiveness of an intensive CPAP (Continuous Positive Airway Pressure) therapy support program compared to usual care in stroke patients with obstructive sleep apnea (OSA) during inpatient rehabilitation (IPR). The study is a multicenter randomized controlled trial (RCT) involving recruitment of about 250 participants across two institutions and randomization of about 200 participants. It compares an intensive support (IS) program for CPAP use with standard support (SS) to evaluate the effectiveness of the IS intervention in increasing CPAP usage during and after stroke rehabilitation. The Intensive Support (IS) group will receive a multicomponent intensive behavioral adherence program, which includes a CPAP technical support intervention, Motivational Enhancement Therapy (MET), and a Mobile Health intervention. Outcomes measured include CPAP adherence as measured by average nightly use in minutes between randomization and 3 months and the modified Rankin Scale (mRS-9Q) to evaluate stroke recovery.

Official Title

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

Quick Facts

Study Start:2025-01-15
Study Completion:2028-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06722755

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Sofia Grande
CONTACT
206-543-7589
grands@uw.edu

Principal Investigator

Sandeep Khot, MD, MPH
PRINCIPAL_INVESTIGATOR
University of Washington
Devin Brown, MD, MS
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

Rancho Research Institute
Downey, California, 90242
United States
University of Washington - Harborview Medical Center
Seattle, Washington, 98104
United States

Collaborators and Investigators

Sponsor: University of Washington

  • Sandeep Khot, MD, MPH, PRINCIPAL_INVESTIGATOR, University of Washington
  • Devin Brown, MD, MS, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-15
Study Completion Date2028-08-01

Study Record Updates

Study Start Date2025-01-15
Study Completion Date2028-08-01

Terms related to this study

Keywords Provided by Researchers

  • behavioral therapy
  • continuous positive airway pressure
  • stroke recovery
  • self determination
  • sleep apnea

Additional Relevant MeSH Terms

  • Stroke Patients
  • CPAP
  • OSA - Obstructive Sleep Apnea