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 range
18 Years
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.