Improving Outcomes for Patients With SDB and Insufficient Sleep

Completed · Not applicable

Conditions studied: Sleep Apnea, Insufficient Sleep Syndrome, Sleep, Hypertension

In brief

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.

Key facts

Study ID

NCT04279834

Run by

Wayne State University

People needed

558

Starts

2020-10-16

Expected to finish

2025-08-11

Last updated by the study team

2025-12-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• 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.

Where it is running

• Wayne State University — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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