KPAP Adherence Crossover Study

Part of paid clinical trials in Murfreesboro, Tennessee.

Sponsor
SleepRes Inc.
Study ID
NCT06413134
Status
Not Yet Recruiting

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Conditions

  • Obstructive Sleep Apnea

Eligibility Criteria

Sex
ALL
Age
20 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • KPAP — DEVICE
    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 — DEVICE
    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.

Study Details

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 Dates

Start date
Jul 1, 2026
Status verified
May 2026
Primary completion
Dec 1, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: 4-weeks breathing on APAP
    Patients will breathe on APAP for 4 weeks simulating normal therapy. Usage, leak, P95/P90 and AHI will be recorded and averaged over the duration.
  • Experimental: 4-weeks breathing on KPAP
    Patients will breathe on TheraPAP for 4 weeks, which is the therapy under evaluation. Usage, leak, P95/P90 and AHI will also be recorded and averaged over the duration.

Primary Outcome Measure

Usage [ Time Frame: Averaged over every night for each 4-week arm ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Sleep Centers of Middle TennesseeMurfreesboroTennessee37129
Craig Salazar
[email protected]
615-893-4896
Bernard Hete, PhD (SUB_INVESTIGATOR)
William H Noah, MD (SUB_INVESTIGATOR)

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By research site
Sleep Centers of Middle Tennessee· Murfreesboro, TN

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