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KPAP vs EPR for Comfort

NCT07530510 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-04-15

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

APAP + KPAP

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)

DEVICE

APAP + EPR

A ResMed device will deliver auto-adjusting positive airway pressure (APAP) + Expiratory Pressure Relief set on level 3

Sponsors & Collaborators

  • SleepRes Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2026-12-01
Completion
2026-12-31
FDA Device
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07530510 on ClinicalTrials.gov