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 range20 Years – 80 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
✓. 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.
✕. The presence of any other sleep disorder (insomnia, periodic limb movement disorder, etc).
✕. Prior therapy or treatment for OSA.
✕. Chronic oxygen therapy.
What they're measuring
1
Usage
Timeframe: Averaged over every night for each 4-week arm