KPAP Adherence Crossover Study

Starting soon · Not applicable

Conditions studied: Obstructive Sleep Apnea

In brief

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.

Key facts

Study ID

NCT06413134

Run by

SleepRes Inc.

People needed

30

Starts

2026-07-01

Expected to finish

2026-12-31

Last updated by the study team

2026-05-06

Who can join

Age: 20 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• AHI > 10 on a previous PSG or HST (hypopneas requiring 4% desaturation).
• Central apneas < 25% of events
• PLM (Periodic Limb Movements) arousal index < 15

You may not qualify if…

• 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.
• Excessive alcohol consumption (>14 drinks/week).
• The use of any illegal drug(s).
• Any condition that in the investigator's opinion would present an unreasonable risk to the participant, or which would interfere with their participation in the study or confound study interpretation.

Where it is running

• Sleep Centers of Middle Tennessee — Murfreesboro, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.