NCT07613281
Serene Sleep Palatal Implant System Clinical Confirmatory Trial in Participants Who Snore or Are Diagnosed With Mild-to-moderate Obstructive Sleep Apnea (OSA).
Not Yet Recruiting
NAAges 18+InterventionalTreatmentSerene Sleep, Inc.
~26 participants
Updated 2026-06-01 on ClinicalTrials.gov
What's tested:Palatal Implant System
At a glance
Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of Participants with Implant Extrusion at 30 Days and Absence of Serious Adverse Device Effects (SADEs) [Hybrid Composite Safety Endpoint]
Measured over From baseline to 30 days post-procedure
Conditions
Where it's being run
2 sites across 2 statesCalifornia1
Georgia1
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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
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
What this trial measures
- Proportion of Participants with Implant Extrusion at 30 Days and Absence of Serious Adverse Device Effects (SADEs) [Hybrid Composite Safety Endpoint]From baseline to 30 days post-procedure
The primary endpoint for this study is to evaluate the adverse event profile of the Serene Sleep Palatal Implants, in comparison to those observed with the previously marketed Pillar Palatal Implants, in subjects treated for snoring and/or mild-to-moderate OSA.