Improving Outcomes for Patients With SDB and Insufficient Sleep (RESTORE)

  • STATUS
    Recruiting
  • End date
    Jul 31, 2024
  • participants needed
    495
  • sponsor
    Wayne State University
Updated on 24 July 2022
apnea
somnolence
self monitoring
sleep-disordered breathing
apnea-hypopnea index
total sleep time
Accepts healthy volunteers

Summary

The purpose of this study is to look at how sleep disordered breathing (SDB) and not getting enough sleep each night contribute to daytime sleepiness. The investigators also want to determine the treatment that works best for improving daytime sleepiness.

In this study, the investigators are comparing 2 programs that may improve symptoms of daytime sleepiness.

Description

Sleep disordered breathing (SDB) is associated with significant adverse health consequences including cardiovascular disease, motor vehicle accidents, daytime functional impairments, and mortality risk. A significant proportion of the populace has mild to moderate SDB.

This study is a randomized control trial (RCT) to test the efficacy of a program combining patient monitoring with behavioral techniques across Positive Airway Pressure (PAP) and sleep education. Screening for sleep apnea will be performed based on a phone screening questionnaire and an initial polysomnography (collected from another clinic or collected by research staff). Both objective (actigraphy, Psychomotor Vigilance Test, 24 hour blood pressure monitoring, office blood pressure, and EndoPATTM) and self-report (questionnaire/diary) sleep measures will be collected, as well as other health-related measures. Participants with an Apnea Hypopnea Index (AHI) between 5 and 30, and who meet all inclusion/exclusion criteria will be randomized to one of two educational programs.

Both groups will receive education about SDB and sleep, but only one group will receive PAP devices. This information will be provided to participants as part of the 4-session intervention. Follow-up assessments will be conducted immediately following the intervention and after 3-months.

Main study outcomes (lapses, daytime sleepiness, endothelial function and ambulatory blood pressure) will be assessed at baseline, post treatment and 3 month. Data will be analyzed using "intention to treat" principles, and appropriate statistical methods for clinical trials.

Details
Condition Sleep Apnea, Insufficient Sleep Syndrome, Sleep, Hypertension
Treatment PAP Treatment, Sleep Education I, Sleep Education II
Clinical Study IdentifierNCT04279834
SponsorWayne State University
Last Modified on24 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Over age 18 years
Diagnosed with mild to moderate sleep disordered breathing (SDB) (Apnea Hypopnea Index of 5-30)
Additional Inclusion Criteria for randomization will be
ESS score >6
Total sleep time <7 hours at least 4 nights per week, based on baseline sleep diary

Exclusion Criteria

Current use of PAP or oral appliance therapy for SDB
Severe respiratory or cardiovascular disease (e.g., ventilatory failure, congestive heart failure)
A recent health event that may affect sleep (e.g. recent surgery or hospitalization)
Current alcohol or substance use disorder (<90 days sobriety) or significant unstable psychiatric comorbidity (e.g., suicidal ideation, psychosis)
Pregnancy or within 6 months post-partum
Commercial drivers and individuals at risk for motor vehicle accidents (MVA) or ESS>18
Significant comorbid sleep disorders (e.g., severe insomnia, narcolepsy); and
Central sleep apnea (defined as central apnea/hypopnea index >5, and >50% of total AHI)
Use of sedative-hypnotic medications higher than the maximal acceptable therapeutic dose range
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note