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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
Diagnosed with mild to moderate sleep disordered breathing (SDB) (Apnea Hypopnea Index of 5-30)
Over age 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-months after randomization
Awards & highlights

RESTORE Trial 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.Check my eligibility
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.See study design
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.

RESTORE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with a mild to moderate sleep breathing issue.
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I am over 18 years old.

RESTORE Trial 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

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

RESTORE 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
307 Previous Clinical Trials
108,284 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,820 Previous Clinical Trials
47,298,942 Total Patients Enrolled
15 Trials studying Sleep Apnea
5,063 Patients Enrolled for Sleep Apnea
M. Safwan Badr, MD, MBAPrincipal InvestigatorWayne State University

Media Library

PAP Treatment Clinical Trial Eligibility Overview. Trial Name: NCT04279834 — N/A
Sleep Apnea Research Study Groups: Sleep Education I, PAP Treatment
Sleep Apnea 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are allowed to participate in this experiment?

"The trial is still recruiting patients, according to the latest information available on clinicaltrials.gov. This particular study was posted on October 16th 2020 and edited as recently as July 13th 2022. They are looking for 495 individuals total, across 1 location."

Answered by AI

Are there any current openings for patients who want to participate in this research?

"That is accurate. The clinical trial was originally posted on 10/16/2020 and was last edited on 7/13/2022, as indicated by clinicaltrials.gov. This study is searching for 495 participants between 1 locations."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
What site did they apply to?
Wayne State University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

I’ve tried numerous sleep aid meds to no avail and I believe some of my sleeping issues are from my BiPAP usage.
PatientReceived 2+ prior treatments
~0 spots leftby Apr 2024