Stroke and CPAP Outcome Study 3 Randomized Controlled Trial

Official title

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

Overview

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.

Detailed description

Within an investigator-initiated, phase 2 multicenter randomized controlled trial, we will test the effect of the multicomponent behavioral adherence intervention on 3-months of CPAP use among stroke patients with obstructive sleep apnea (OSA) and continuous positive airway pressure (CPAP) therapy initiated during inpatient rehabilitation (IPR). The study will be conducted at 2 IPR centers, University of Washington (UW) in Seattle, WA., and Rancho Los Amigos National Rehabilitation Center (RLANRC) in Los Angeles, CA. Over a \~3-year period, adult patients recovering from acute stroke within the past 30 days will be recruited upon IPR admission to these centers and tested for OSA through a simple, portable cardiorespiratory study with automated software. Eligible participants with OSA will be randomized to CPAP plus: either the adapted adherence intervention or control. All randomized subjects will be treated with auto-titrating CPAP or aCPAP. CPAP use will be measured electronically. Both groups will continue CPAP for a 3-month treatment period. We anticipate enrolling approximately 250 participants over the \~3 years of recruitment to randomize 200 eligible participants. The primary endpoint will be the average nightly minutes of CPAP use over the 90-day period, objectively measured, and the secondary outcome will be the Modified Rankin Scale-9 questions assessed at 3 months by phone.

Interventions

• Device CPAP device
  Eligible participants with OSA will be started on automatically-adjusting CPAP.
• Behavioral CPAP technical support
  Trained personnel will conduct mask selection and fitting, provide continual troubleshooting, and train participants on CPAP.
• Behavioral Phone follow-up for adherence feedback and self-management skills
  The research coordinator will call participants approximately monthly to provide any needed support.
• Behavioral myAir
  Study personnel will assist participants in registering for and using the myAir (ResMed) self-tracking app. This app also provides a library of how-to videos and provides email updates to participants.
• Behavioral Tailored messages
  Tailored text messages will be sent to participants. Two-way texting messaging will also be available between the study team and participants.
• Behavioral Written Materials
  A binder of written educational materials will be provided to participants.
• Behavioral Motivational Enhancement Therapy (MET)
  A trained sleep coach will conduct up to 5 MET sessions with participants and 2 sessions with a CPAP partner during the study time period.

Primary outcome measures

• CPAP Adherence [Time frame: 3 months]

Secondary outcome measures (1)

• Stroke recovery measure [Time frame: 3 months]

Eligibility criteria

Inclusion criteria include:

• 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 (LAR)) able to be consented in English or Spanish.

Exclusion criteria include:

• Unable to obtain informed consent from participant or LAR in English or Spanish
• Incarcerated
• Known pregnancy-determined by reviewing clinical data
• Current mechanical ventilation, tracheostomy, or supplemental oxygen use > 4L/min
• Use of positive airway pressure 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) including any benzodiazepine, barbiturate, general anesthesia, or conscious sedation within the prior 48 hours of the planned portable sleep apnea study
• Anticipated inpatient rehabilitation length of stay < 5 nights
• Co-morbid conditions that limit OSA testing or CPAP use in the judgement of the study team
• Recent cranial or spinal surgery with known or possible CSF leak or pneumocephalus within past 3 months
• Patients at significant risk of aspiration that could render the patient at risk of harm from use of CPAP, in the opinion of the site PI.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

United States · 2 centers

• Rancho Research Institute — Downey
• University of Washington - Harborview Medical Center — Seattle

Identifiers

NCT: NCT06722755 · STUDY00021430 · R01HL164394-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗