Serene Sleep Palatal Implant System Clinical Confirmatory Trial in Participants Who Snore or Are Diagnosed With Mild-to-moderate Obstructive Sleep Apnea (OSA).

This clinical investigation is a prospective, non-randomized, parallel-group clinical investigation conducted at two (2) investigative sites. Study participants will be assigned to one of two study groups, snoring and obstructive sleep apnea, in a parallel manner based on predefined eligibility criteria. The study aims to evaluate and compare outcomes between the two groups under investigation. 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. The design allows for the concurrent enrollment and follow-up of participants in both arms, enabling direct observation of differences in safety across the groups over time.

NCT Number	NCT07613281
Lead Sponsor	Serene Sleep, Inc.
Conditions	Snoring, OSA - Obstructive Sleep Apnea
Enrollment	26 participants
Start Date	2026-06
Primary Completion	2026-09 (estimated)
Study Completion	2026-10 (estimated)
Updated on ClinicalTrials.gov	2026-06-01