Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Tiny implant in the mouth aims to quiet snoring and ease sleep apnea

NCT ID NCT07613281

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a small device called the Serene Sleep Palatal Implant, placed in the soft palate to reduce snoring and mild-to-moderate obstructive sleep apnea. About 26 adults will be split into two groups based on their condition. The main goal is to check safety, like whether the implant stays in place and causes no serious side effects, compared to an older implant. Researchers will also track changes in snoring severity and sleep quality.

What this could mean

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

Active substance
Palatal implant system (a small device placed in the soft palate to stiffen tissue and reduce airway collapse)
What this could lead to
If it works, this could offer a simple, one-time procedure to reduce snoring and improve breathing during sleep for people with mild-to-moderate sleep apnea.
What could go wrong
This is a very small, early-stage safety study with only 26 participants. The implant may cause discomfort, extrusion, or fail to improve symptoms. Results may not apply to everyone.

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 26 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Oct 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 A potential participant must meet ALL the following criteria to be enrolled into this study: 1. Participant is ≥18 years of age. 2. Participant has Body Mass Index (BMI) less than or equal to 30 kg/m² 3. Participant has a tonsil grade less than or equal to 2 4. Participant has a Friedman Tongue Position (FTP) I or II 5. Participant is able to provide voluntary written informed consent. For a snoring participant to be selected for the study: * Confirmed identification of palatal snoring * Investigators will utilize standard of care clinical assessment methods to confirm the presence of palatal snoring prior to enrollment. These methods may include patient-reported history, physical examination of the upper airway, and auscultation or audio recordings. * Confirmed elimination of potential sleep apnea diagnosis * If the evaluating doctor suspects that the participant may be experiencing OSA, investigators will utilize standard of care clinical assessment methods to confirm OSA. * A resulting AHI \<5 would classify the participant as an eligible snoring subject For an OSA participant to be selected for study: Confirmed identification of apnea caused by palatal collapse * Investigators should be able to make this identification through intraoral evaluation in accordance with their standard of care * Confirmed mild-to-moderate classification of OSA * If the evaluating investigator knows or suspects that the participant may be experiencing OSA, standard of care diagnostic methods will be used as confirmation. * A resulting AHI between 5 and 30 would classify the participant as an eligible OSA subject. EXCLUSION CRITERIA A potential participant will be excluded from enrollment if ANY of the following conditions apply: 1. A record of allergic reaction to polyethylene terephthalate (PET) / polyester 2. An overly sensitive gag reflex 3. Septal deviation or nasal obstruction 4. Nasal polyps 5. Severe seasonal allergies 6. Soft palate length insufficient to accommodate implants 7. Prior Diagnosis of Lingual tonsil hypertrophy 8. Hypopharyngeal obstruction 9. Previous pharyngeal surgery 10. Previous upper respiratory tract cancer or radiation therapy 11. Active respiratory tract infection 12. Dysphagia or speech disorder 13. Neurologic disorder 14. Unstable psychiatric disorder 15. Pregnant or breastfeeding 16. History of falling asleep driving or Motor Vehicle Accident (MVA) due to sleepiness 17. Clinical Presentation that suggests Severe OSAHS (ESS \>20, participant report of choking or gasping during sleep, etc.) 18. Marfan's Syndrome, Ehler-Danlos syndromes or other disorders of connective tissue and/or muscular tissue 19. Other sleep disorders 20. Other significant craniofacial anomaly 21. Participant is participating in any of the following: * A study with the same or similar primary endpoint * Any study in which the investigator determines may interfere with the results of this study 22. Participant is unwilling to complete all study related assessments and follow-up visits 23. Participant is unwilling or unable to abstain from all alcohol consumption for 24 hours leading up to the intake sleep study 24. Participant is unwilling or unable to abstain from all smoking, vaping, and/or oral tobacco products for 48 hours following the procedure 25. Participant has any other medical condition which in the opinion of the Investigator will make participation medically unsafe or interfere with the study results

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for OSA - obstructive sleep apnea are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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 study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    2 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

  • Aesthetic Surgery Center

    San Francisco, California, 94102, United States

    Contact Email: •••••@•••••

  • Augusta ENT

    Evans, Georgia, 30907, United States

More trials for these conditions

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