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KPAP Adherence Crossover Study
Sponsor: SleepRes Inc.
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.
Official title: A Prospective, Randomized, Crossover Study of Therapy Adherence With Kairos Positive Airway Pressure (KPAP) Compared to Automatic Adjusting Positive Airway Pressure (APAP) for the Treatment of Obstructive Sleep Apnea (OSA)
Key Details
Gender
All
Age Range
20 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-07-01
Completion Date
2026-12-31
Last Updated
2026-05-06
Healthy Volunteers
No
Conditions
Interventions
KPAP
TheraPAP is a novel CPAP-based therapy in which pressure is dropped as much as 5 cmH2O starting at the beginning of inspiration and extending through the end of expiration where it rises back up to the true therapy pressure for a short period. It improves comfort by providing pressure only when it is needed and maintaining it at a low level the rest of the time. Normal CPAP/APAP therapy keeps pressure at the therapy level during the entire breath cycle, except with some alternate approaches where pressure is decreased but only during the expiratory phase.
APAP
Standard CPAP therapy where therapy pressure is automatically adjusted to prevent respiratory events from occurring. The TheraPAP prototype device will be used to operate in the APAP mode in addition to the TheraPAP intervention mode.
Locations (1)
Sleep Centers of Middle Tennessee
Murfreesboro, Tennessee, United States