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KPAP vs AirSense 11 With EPR

NCT07751562 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-08-07

No results posted yet for this study

Summary

The KPAP vs AirSense 11 with EPR study is a randomized, crossover study in which treatment efficacy will be compared between SleepRes APAP + KPAP and ResMed APAP + EPR. Participants will be chosen from those with a formal OSA diagnosis (following an in-lab polysomnogram, a split-night study or a home sleep apnea test) within the past 2 years and on PAP therapy.

Upon signing an informed consent, participants will be randomized to the order of study and which device will be used first: APAP + KPAP (delivered by a SleepRes device) or APAP + EPR (delivered by a ResMed device). Participants will be blinded to the sequence order. They will then be invited to the laboratory for two overnight sleep studies, one on each treatment device, in the order determined by the randomization. Prior to each overnight, they will have to observe withdrawal of their home PAP treatment for 3 nights. The KPAP drop will be set to the maximum level (i.e., 5 cmH2O), while EPR will be set on 3. APAP from both manufacturers will be set on a 5-20 cmH2O pressure range. The next morning of each sleep study, participants will be administered visual analog scale (VAS) questionnaires to examine subjective sleep quality (1=best sleep quality; 10=worst sleep quality) and, after all studies are completed, a device subjective preference (1=APAP+KPAP was extremely better than APAP+EPR; 10=the opposite).

The study will be single blinded with both the participants (the device will be concealed in the laboratory so that participants will not be able to understand what treatment they are on) and the registered technician scoring the polysomnograms (by an independent scoring partner, Sleep Strategies) blinded to treatment allocation.

Conditions

  • Sleep Apnea, Obstructive

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
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2027-02-01
Completion
2027-02-28
FDA Device
Yes

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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 NCT07751562 on ClinicalTrials.gov