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Can a new pressure relief mode outperform standard therapy for sleep apnea?

NCT ID NCT07751562

Disease control Sponsor: SleepRes Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 07, 2026 · Last updated Aug 07, 2026

Summary

This study tests whether a new auto-adjusting positive airway pressure (APAP) device with a feature called Kairos PAP (KPAP) works better than a standard APAP device with expiratory pressure relief (EPR) for people with obstructive sleep apnea. Participants, who already use PAP therapy, will try both devices during overnight sleep studies in a random order. Researchers will measure how well each device reduces breathing pauses and improves sleep quality, and participants will share which device they prefer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Automatic positive airway pressure (APAP) with either Kairos PAP (KPAP) or Expiratory Pressure Relief (EPR)
What this could lead to
If KPAP proves more effective than standard EPR, it could offer a more comfortable and efficient way to manage sleep apnea, potentially improving sleep quality and adherence.
What could go wrong
This is a small crossover study (30 participants), so results may not apply to everyone. Individual responses vary, and the study doesn't measure long-term outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

obstructive sleep apnea syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sleep apnea, obstructive

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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