Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT04279834
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04279834
Study Brief:
Protocol Section:
NCT04279834