KPAP Adherence Crossover Study (NCT06413134) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
KPAP Adherence Crossover Study
United States30 participantsStarted 2026-07-01
Plain-language summary
A device able to provide less positive airway pressure (PAP) for the entire duration of inspiration and roughly half the duration of expiration, designated KPAP, is being developed by SleepRes for the treatment of obstructive sleep apnea (OSA). In prior studies, the administration of higher inspiratory than expiratory PAP did not substantially increase treatment efficacy or adherence to continuous PAP (CPAP), which remains low. In our recent investigation, we demonstrated that the addition of a resistor to the CPAP circuit to reduce inspiratory PAP increased subjective comfort. In another study, we showed that KPAP improved subjective comfort during wakefulness vs. fixed CPAP, while maintaining treatment efficacy. The present study, KPAP Adherence 1, is a randomized, crossover study designed to examine whether KPAP can improve adherence over APAP as an at home treatment for OSA.
Who can participate
Age range
20 Years – 80 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
. AHI \> 10 on a previous PSG or HST (hypopneas requiring 4% desaturation).
. Central apneas \< 25% of events
. PLM (Periodic Limb Movements) arousal index \< 15
Exclusion criteria
. A female of child-bearing potential that is pregnant or intends to become pregnant.
. Any unstable or severe medical condition of any organ system including congestive heart failure, COPD, renal failure, neuromuscular disease, etc., or at the discretion of the site Principal Investigator (PI).
. Taking medication that may affect sleep, sleepiness, or alertness including hypnotics, sedatives, alerting agents, stimulants, anticonvulsants, etc.
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.
What they're measuring
1
Usage
Timeframe: Averaged over every night for each 4-week arm