KPAP vs AirSense 11 With EPR

August 3, 2026 updated by: SleepRes Inc.

A Randomized Crossover Study of Automatic Positive Airway Pressure (APAP) Treatment Efficacy: Kairos APAP (With KPAP) Versus ResMed AirSense APAP With EPR

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • BMI above 18 kg/m2, inclusive
  • Diagnosis of OSA meeting all the following criteria: AHI4 > 10 on a previous PSG or HST (within the past 2 years), central apneas < 25% of events, PLM arousal index < 15 if recorded
  • Current treatment with PAP of any nightly duration.
  • Subject is fluent in English and subject understands the study protocol and is willing and able to comply with study requirements and sign informed consent.
  • Participant voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB)-approved informed consent prior to performing any of the study-related procedures.

Exclusion Criteria

  • 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).
  • The presence of a psychiatric disorder, including attempted suicide within 1 year prior to screening, or current suicidal ideation.
  • A serious illness or infection in the past 30 days.
  • Prior/Concomitant Therapy including: chronic nocturnal oxygen therapy, mandibular advancement device, active hypoglossal nerve stimulation implant.
  • Excessive alcohol consumption (>21 drinks/week).
  • The use of any illegal drug(s).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: APAP + KPAP
Auto-adjusting positive airway pressure + Kairos PAP
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)
Active Comparator: APAP + EPR
Auto-adjusting positive airway pressure + Expiratory Pressure Relief
Device: APAP + EPR
A ResMed device will deliver auto-adjusting positive airway pressure (APAP) + Expiratory Pressure Relief set on level 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment efficacy
Time Frame: This outcome will be evaluated after one night of treatment
Per residual apnea hypopnea 4 (AHI4) index determined through an in-laboratory polysomnography
This outcome will be evaluated after one night of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Leak
Time Frame: This outcome will be evaluated after one night of treatment
Per leak calculated by and downloaded from the device
This outcome will be evaluated after one night of treatment
Next-morning subjective sleep quality
Time Frame: This outcome will be evaluated after one night of treatment
Per 10-point Visual Analog Scale
This outcome will be evaluated after one night of treatment
Total sleep time
Time Frame: This outcome will be evaluated after one night of treatment
Amount of sleep in min determined through an in-laboratory polysomnography
This outcome will be evaluated after one night of treatment
Sleep efficiency
Time Frame: This outcome will be evaluated after one night of treatment
Time asleep divided by time in bed determined through an in-laboratory polysomnography
This outcome will be evaluated after one night of treatment
AHI3a
Time Frame: This outcome will be evaluated after one night of treatment
Residual apnea hypopnea index (calculated with hypopnea associated with 3% desaturations or occurrence of an arousal) determined through an in-laboratory polysomnography
This outcome will be evaluated after one night of treatment
Next-morning device preference
Time Frame: This outcome will be evaluated after one night of treatment
Per 10-point Visual Analog Scale
This outcome will be evaluated after one night of treatment
P95
Time Frame: This outcome will be evaluated after one night of treatment
Pressure that is delivered by the device for 95% of the usage time
This outcome will be evaluated after one night of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SleepRes Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 28, 2027

Study Registration Dates

First Submitted

August 3, 2026

First Submitted That Met QC Criteria

August 3, 2026

First Posted (Actual)

August 7, 2026

Study Record Updates

Last Update Posted (Actual)

August 7, 2026

Last Update Submitted That Met QC Criteria

August 3, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ext 0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We only plan to share the results after we publish them

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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