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PAP Treatment and Sleep Education for Sleep Apnea (RESTORE Trial)
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.
RESTORE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowRESTORE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.RESTORE Trial Design
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Who is running the clinical trial?
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- I am a commercial driver or at high risk for car accidents.Your ESS score is greater than 6.You usually sleep less than 7 hours for at least 4 nights every week, as recorded in your sleep diary.I do not have severe lung or heart disease.I am currently using a device at night to help with my sleep breathing problem.I have been diagnosed with central sleep apnea.I have been diagnosed with a mild to moderate sleep breathing issue.I do not have severe sleep disorders like insomnia or narcolepsy.You sleep less than 7 hours for at least 4 nights a week, as recorded in your sleep diary.You have struggled with alcohol or drug addiction in the last three months, or have serious mental health issues like thinking about hurting yourself or having trouble telling what's real and what's not.I use sleep or anxiety medication more than the recommended dose.I am over 18 years old.I recently had surgery or was hospitalized, which may affect my sleep.Your ESS score is higher than 6.
- Group 1: Sleep Education I
- Group 2: PAP Treatment
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
Why did patients apply to this trial?
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