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PAP Treatment and Sleep Education for Sleep Apnea (RESTORE Trial)

N/A
Recruiting
Led By M. Safwan Badr, MD, MBA
Research Sponsored by Wayne State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Over age 18 years
Be older than 18 years old
Must not have
Commercial drivers and individuals at risk for motor vehicle accidents (MVA) or ESS>18
Severe respiratory or cardiovascular disease (e.g., ventilatory failure, congestive heart failure)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-months after randomization
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying how sleep disordered breathing and not getting enough sleep each night contribute to daytime sleepiness and whether 2 programs may improve symptoms of daytime sleepiness.

Who is the study for?
This trial is for adults over 18 with mild to moderate sleep disordered breathing (SDB) and who often get less than 7 hours of sleep. They should feel sleepy during the day, but not be at high risk for falling asleep in dangerous situations like driving. People using certain sleep medications or treatments, those with severe health issues, substance use disorders, or other major sleep conditions can't join.
What is being tested?
The study aims to see which of two programs—PAP Treatment or Sleep Education I—is better at reducing daytime sleepiness for people with SDB and insufficient nightly sleep. Participants will try one of these approaches to find out how it affects their alertness during the day.
What are the potential side effects?
While specific side effects are not listed here, PAP treatment may cause discomfort such as nasal congestion or dryness, while educational interventions typically do not have physical side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am a commercial driver or at high risk for car accidents.
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I do not have severe lung or heart disease.
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I am currently using a device at night to help with my sleep breathing problem.
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I have been diagnosed with central sleep apnea.
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I do not have severe sleep disorders like insomnia or narcolepsy.
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I use sleep or anxiety medication more than the recommended dose.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-months after randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-months after randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Epworth Sleepiness Scale (ESS)
Secondary study objectives
24-hours Ambulatory Blood Pressure
Fatigue Severity Scale (FSS)
Psychomotor Vigilance Test (PVT)
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Sleep Education IActive Control1 Intervention
Participants will attend four weekly sessions to receive education about strategies to improve sleep.
Group II: PAP TreatmentActive Control1 Intervention
Participants will receive a PAP device and will attend four weekly sessions to receive education about this treatment.

Find a Location

Who is running the clinical trial?

Wayne State UniversityLead Sponsor
314 Previous Clinical Trials
110,402 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,935 Previous Clinical Trials
47,791,836 Total Patients Enrolled
M. Safwan Badr, MD, MBAPrincipal InvestigatorWayne State University

Media Library

PAP Treatment Clinical Trial Eligibility Overview. Trial Name: NCT04279834 — N/A
High Blood Pressure Research Study Groups: Sleep Education I, PAP Treatment
High Blood Pressure Clinical Trial 2023: PAP Treatment Highlights & Side Effects. Trial Name: NCT04279834 — N/A
PAP Treatment 2023 Treatment Timeline for Medical Study. Trial Name: NCT04279834 — N/A
~46 spots leftby May 2025
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