Tiny implant in the mouth aims to quiet snoring and ease sleep apnea
NCT ID NCT07613281
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 Hide 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.
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.
-
The study's own enquiry address
This study publishes an address for enquiries. See it below .
-
The places running it
2 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
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.
- Can a night of sleep pills ease breathing in sleep apnea?
- Could a smart pillow quiet snoring and boost sleep quality?
- Can a pill replace the CPAP machine for sleep apnea?
- A Parent's smartphone video could be a new tool to screen kids for sleep apnea
- Can a simple questionnaire spot hidden sleep apnea in millions?
- Jaw-Widening device may ease sleep apnea without surgery