KPAP vs EPR for Comfort

Sponsor
SleepRes Inc.
Study ID
NCT07530510
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

  • APAP + KPAP — DEVICE
    A SleepRes device will deliver auto-adjusting positive airway pressure (APAP) + Kairos PAP at the maximum drop (1, 2, 3, 4, 5 cmH2O at background pressures of 6, 7, 8, 9, 10 cmH2O, respectively)
  • APAP + EPR — DEVICE
    A ResMed device will deliver auto-adjusting positive airway pressure (APAP) + Expiratory Pressure Relief set on level 3

Study Details

The KPAP EPR Home is a randomized, crossover study in which subjective comfort will be compared between SleepRes APAP + KPAP and ResMed APAP + EPR. Participants will be individuals with newly diagnosed OSA who have not previously tried any PAP treatment (PAP-naïve). Upon signing an informed consent, participants will be randomized to receiving either APAP + KPAP (delivered by a SleepRes device) or APAP + EPR (delivered by a ResMed device) for home use. Participants will be asked to use the devices (in the order of randomization) for 4 days each, with 3 days of washout in between. Participants will be blinded to the sequence order, even though they will receive machines that are not identical at each treatment. The KPAP drop will be set to the maximum level (i.e., 5 cmH2O), while EPR will be set on 3. APAP will be set on the full pressure range (i.e., 5-20 cmH2O). After each period, each individual will be asked to rate their device preference according to a 10-point visual analog (VAS) scale (i.e., 1=extremely uncomfortable treatment; 10=extremely comfortable treatment). After usage, the devices will be returned to the office and device data will be downloaded.

Key Dates

First listed
Apr 15, 2026
Start date
Jun 1, 2026
Status verified
Apr 2026
Primary completion
Dec 1, 2026
Completion
Dec 31, 2026

Study Design

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

Arms

  • Experimental: APAP + KPAP
    Auto-adjusting positive airway pressure + Kairos positive airway pressure
  • Active Comparator: APAP + EPR
    Auto-adjusting positive airway pressure + Expiratory pressure relief

Primary Outcome Measure

Subjective comfort [ Time Frame: This outcome will be evaluated after 4 days of treatment in each arm ]

Central Contacts

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