Improving Outcomes for Patients With SDB and Insufficient Sleep (NCT04279834) | Clinical Trial Compass
CompletedNot Applicable
Improving Outcomes for Patients With SDB and Insufficient Sleep
United States558 participantsStarted 2020-10-16
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.