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Could a Pillow-Like device quiet sleep apnea without drugs?

NCT ID NCT07492420

Symptom relief Sponsor: Amenity Health, 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 2 times

Summary

This study tests the MedCline Sleep System, a device placed on the bed to keep people sleeping on their side. It aims to reduce breathing pauses and snoring in adults with mild obstructive sleep apnea. Researchers will measure changes in apnea and oxygen levels during sleep. The trial involves 35 participants and is currently recruiting.

What this could mean

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

Active substance
MedCline Sleep System (positional therapy device)
What this could lead to
If it works, this device could offer a simple, drug-free way to manage mild sleep apnea at home.
What could go wrong
This is a small early study with only 35 participants. The device may not work for everyone, and results may not apply to more severe cases.

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

40 people

The number who actually took part.

Started

Mar 2026

Finished

Aug 2026

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

18 years and older

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: 1. Diagnosis with mild obstructive sleep apnea (AHI 5-14.9) 2. PSG or HST performed within last 24 months 3. Individuals aged 18 or older 4. Must routinely sleep on a standard mattress and must be able to accommodate the width of the MedCline Sleep System (30") 5. Must be in overall good health, with no significant medical conditions that would interfere with the study procedures or the ability to sleep safely using the MedCline Sleep System 6. Ability to provide written informed consent in accordance with IRB principles 7. Must be stable on any medications for at least 3 months prior to the date of consent Exclusion Criteria: 1. Diagnosis of moderate to severe OSA (AHI \>15) or central sleep apnea 2. Has undergone surgical procedures for sleep apnea within the last six months 3. Clinically significant cardiac or respiratory conditions that may interfere with the study intervention or outcomes. 4. Chronic pain or musculoskeletal disorders, e.g., spinal deformities, scoliosis, kyphosis, back injuries, spinal compressions, or injuries that may affect their ability to sleep comfortably in a lateral position 5. Pregnant or planning to become pregnant during study period 6. Any conditions or circumstances that require frequent night-time awakenings (e.g., nocturia, caregiving responsibilities, or other health issues) 7. Unable or unwilling to use the MedCline Sleep System as required by the study protocol 8. Currently using substances or medications known to significantly alter sleep architecture or respiratory function (e.g., sedatives, narcotics, or alcohol dependency)

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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.

Mild obstructive sleep apnea

Contacts and locations

Locations

  • Clayton Sleep Institute

    St Louis, Missouri, 63123, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.