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New sleep apnea device aims to keep breathing steady all night

NCT ID NCT07559708

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new device called Elara APAP for people with obstructive sleep apnea. The device delivers air pressure to keep the airway open during sleep. About 55 adults who already use an APAP machine will have one night of sleep monitoring to see if the device reduces breathing pauses. The goal is to find out if the device works well enough to manage the condition.

What this could mean

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

Active substance
Elara APAP device (a machine that delivers air pressure to keep the airway open during sleep)
What this could lead to
If successful, this device could offer an effective way to manage obstructive sleep apnea, reducing breathing interruptions and improving sleep quality.
What could go wrong
This is a small, early-stage study (55 people) with no comparison group, so results may not apply to everyone. The device may not work well for all patients or could be uncomfortable.

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 55 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Jun 2026

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

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. Body weight ≥ 30kg 2. Willing and able to consent, adhere to study requirements and receive mask treatment 3. ≥ 18 years of age 4. Diagnosed with OSA (Total AHI \>15 events/hr) by a practicing physician within the last 6 months. A re-diagnosis may be necessary to establish current baseline AHI in case there has been significant weight change or other co-morbidities since the previous diagnosis (per PI discretion) 5. Currently utilizing an APAP Device for ongoing treatment of OSA Exclusion Criteria: 1. Body weight \< 30kg 2. Female currently bearing a child or intending to become pregnant prior to the sleep study. 3. Have implanted pacemaker, ICD or any other medical device that would interfere with the PSG results or safety of the subject undergoing the study 4. Has pneumothorax, pneumomediastinum 5. Has history of Cerebrospinal fluid leakage, craniocerebral trauma, intracranial trauma or pneumocephalus 6. Ongoing shock from various causes untreated 7. Current epistaxis 8. Non-compliant with APAP usage (\< 4 hours per night on 70% of nights) 9. Upper gastrointestinal bleeding that has not been effectively controlled 10. Has obstructive vocal cord polyps 11. Severe coronary heart disease with left heart failure 12. Acute otitis media inflammation (must be resolved prior to sleep study) 13. Excessive respiratory secretions and cough weakness 14. Weak spontaneous breathing 15. Tracheal intubation (nasal or oral) and tracheotomy 16. Severe nasal congestion from various causes 17. Lung bullae 18. Central sleep apnea index \>5 events/hr 19. Have another significant sleep disorder(s) that in the opinion of the investigator would confound the results of the study (e.g. periodic leg movements \>15/hr or insomnia that would interfere with completing the sleep study).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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 Sleep Disorders Center

    Auburn, Alabama, 36832, United States

More trials for these conditions

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