NCT04279834

Improving Outcomes for Patients With SDB and Insufficient Sleep

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 558 (actual)
• Sponsor: Wayne State University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Sleep Apnea
• Insufficient Sleep Syndrome
• Sleep
• Hypertension

Interventions

Type	Name	Description
BEHAVIORAL	PAP Treatment	Motivational enhancement plus remote-monitoring and participant self-monitoring of PAP use.
BEHAVIORAL	Sleep Education I	Motivational enhancement plus participant self-monitoring of sleep.

Timeline

• Start date: 2020-10-16
• Primary completion: 2025-08-11
• Completion: 2025-08-11
• First posted: 2020-02-21
• Last updated: 2025-12-03

Locations

1 site across 1 country: United States