Status:
COMPLETED
Improving Outcomes for Patients With SDB and Insufficient Sleep
Lead Sponsor:
Wayne State University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Sleep Apnea
Insufficient Sleep Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 trea...
Detailed Description
Sleep disordered breathing (SDB) is associated with significant adverse health consequences including cardiovascular disease, motor vehicle accidents, daytime functional impairments, and mortality ris...
Eligibility Criteria
Inclusion
- Inclusion Criteria for enrollment are:
- 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.
Exclusion
Key Trial Info
Start Date :
October 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 11 2025
Estimated Enrollment :
558 Patients enrolled
Trial Details
Trial ID
NCT04279834
Start Date
October 16 2020
End Date
August 11 2025
Last Update
December 3 2025
Active Locations (1)
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1
Wayne State University
Detroit, Michigan, United States, 48201