Device

Intensive CPAP Support for Stroke Patients with Sleep Apnea (SCOUTS3 Trial)

Seattle, WA

N/A

Recruiting

Led By Sandeep Khot, MD, MPH

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Head CT or brain MRI demonstrating an acute ischemic infarction or intraparenchymal hemorrhage within past 30 days

Age 18 years or older

Must not have

Unable to obtain informed consent from participant or LAR in English or Spanish

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if a program that provides intensive support for using a CPAP machine is more effective than the standard care for stroke patients with sleep apnea during rehabilitation. They will have 250 participants

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Who is the study for?

This trial is for stroke patients with obstructive sleep apnea who are currently in inpatient rehabilitation. Participants should be willing to use a CPAP device and engage with various support programs aimed at improving adherence to the therapy.Check my eligibility

What is being tested?

The SCOUTS 3 study tests an intensive CPAP therapy support program against usual care. It involves motivational talks, written materials, phone follow-ups, technical assistance, tailored messages, and myAir app usage to see if these help increase CPAP use during stroke recovery.See study design

What are the potential side effects?

While not explicitly stated here, typical side effects of using a CPAP machine may include discomfort or irritation on the face where the mask sits, dry nose or throat, headaches, bloating and difficulty falling asleep.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I've had a stroke or brain bleed shown on a scan in the last 30 days.

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I am 18 years old or older.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I can give consent in English or Spanish.

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I haven't taken sedatives like benzodiazepines or barbiturates in the last 48 hours.

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I expect to stay in rehab for less than 5 nights.

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I use a ventilator, tracheostomy, or need more than 4L/min of oxygen.

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I have not had brain or spine surgery that could cause a CSF leak or air in the skull in the last 3 months.

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I have a lung condition that makes it hard to use CPAP.

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I have had a stroke due to a tumor, blood vessel abnormality, or bleeding around my brain.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

CPAP Adherence

Secondary study objectives

Stroke recovery measure

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intensive SupportExperimental Treatment7 Interventions

The Intensive Support (IS) group will receive the multicomponent intensive behavioral adherence program, which includes a CPAP technical support intervention, Motivational Enhancement Therapy (MET), and a Mobile Health intervention. Participants assigned to the IS group will also receive the 3 basic supportive treatments, including OSA and CPAP education, respiratory therapy and nursing support during inpatient rehabilitation, and referral to a DME company after inpatient rehabilitation discharge if needed.

Group II: Standard SupportActive Control1 Intervention

Participants assigned to the control group will receive only the 3 basic supportive treatments, including OSA and CPAP education, respiratory therapy and nursing support during inpatient rehabilitation, and referral to a DME company after study completion if needed. CPAP will be set up by the respiratory therapist (or similar personnel) on the inpatient rehabilitation (IPR) unit with standard mask fitting and troubleshooting, if available. Assistance with mask placement will be provided by IPR nurses and respiratory therapy, as needed. The control interventions mimic usual care, which typically entails a setup by respiratory therapy and support for CPAP placement and device maintenance by IPR nurses.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Written Materials

2010

N/A

~1190

Motivational Enhancement Therapy (MET)

2008

Completed Phase 3

~1510