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Could a tiny implant cure your sleep apnea?

NCT ID NCT07243405

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a device called the Lunair Alpha System, a neurostimulator implant that aims to treat moderate to severe sleep disordered breathing. It is for people who cannot use or do not tolerate other treatments like CPAP machines. The trial will check if the device is safe and improves breathing during sleep over 6 to 24 months.

What this could mean

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

Active substance
neurostimulator implant (Lunair Alpha System)
What this could lead to
If it works, this could offer a new treatment option for people with sleep apnea who cannot tolerate standard therapies like CPAP.
What could go wrong
This is an early study with only 45 people, so results may not apply to everyone. The implant requires surgery and carries risks like infection or device-related side effects.

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 45 people

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

Started

Jul 2025

Expected to finish

Dec 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

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: * Subject does not tolerate, not compliant to, or have access to alternative Sleep Disordered Breathing treatments * Subject has moderate to severe sleep disordered breathing as diagnosed by PSG Exclusion Criteria: * Subject is taking opioids, narcotics, sleep or psychotic medications or supplements that may alter consciousness, the pattern of respiration, sleep architecture, or with known effect on sleep-wake function or alertness. * Any reason for which, in the judgement of the investigator, the subject is considered to be a poor study candidate * Subject has previous upper respiratory tract (URT) surgery or procedure (e.g., uvula, soft palate or tonsils) within 60 days prior to Screening PSG. * Subject has a need for chronic supplemental oxygen therapy for any reason * Subject has other sleep disorders or sleep hygiene behaviors that confound functional assessments of sleepiness * Subject has severe chronic kidney disease * Subject exhibits ongoing misuse of alcohol, tobacco, caffeine, or recreational drugs that would impact either the results of or the participation in a sleep study * Subject conducts work or regular activities requiring vigilance * Subject is unwilling or unable to refrain from consumption of alcoholic beverages for 24 hours prior to the start of each PSG study * Subject is unwilling or unable to refrain from sleep disordered breathing treatments or devices * Subject has an active systemic infection at the time of implant * Subject has clinical evidence of immunodeficiency * Any condition likely to require future MRI or diathermy * Subject is pregnant * Subject has severe nasal obstruction that could restrict airflow * Subject has any trauma to the upper airway * Subject has previous surgical resection, prior or current radiation therapy for cancer or congenital malformations in the larynx, tongue, or throat

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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

  • Hospital Paitilla

    RECRUITING

    Panama City, Provincia de Panamá, Panama

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