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Mattress gadget could Fine-Tune sleep apnea therapy at home

NCT ID NCT07186725

Knowledge-focused Sponsor: Isabel Moreno Hay Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests if a special pad placed under the mattress can help doctors better adjust a mouthpiece used to treat obstructive sleep apnea. About 70 adults with sleep apnea will use the device at home while their treatment is fine-tuned. The goal is to see if the device accurately tracks breathing and oxygen levels, making it easier to find the right mouthpiece setting without repeated clinic visits.

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 70 people

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

Started

Jan 2026

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 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: * Diagnosis of Obstructive Sleep Apnea demonstrated with a sleep study polysomnography or home sleep study (PSG or HSAT), manually scored by a sleep physician according to the 2017 American Academy of Sleep medicine scoring guidelines. * Willingness to commute to the OFP clinic every 2 weeks during MAD titration period. * Consent to partake in the study. Exclusion Criteria: * Diagnosis of central or mixed sleep apnea. * Neurocognitive disease. * Concomitant therapy with PAP therapy. * Allergic to the appliance material (Polyamide 12). * Presence of active dental decay, ill-fitting dental restorations, or crown to root ratio unfavorable. * Inadequate English language comprehension. * Lack of coordination or dexterity to insert/remove the MAD intraorally. * Inability to tolerate digital dental impressions. * Patients with concomitant diagnosed sleep disorders, including narcolepsy, restless leg syndrome, rapid eye movement sleep behavior disorder).

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Conditions

The condition(s) this trial relates to.

obstructive sleep apnea syndrome sleep apnea syndrome

As listed by the trial registrant

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

Obstructive sleep apnea (OSAS) Obstructive sleep apnea (SAOS)

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • University of Kentucky

    RECRUITING

    Lexington, Kentucky, 40506, United States

More trials for these conditions

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