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

Part of paid clinical trials in San Francisco, California.

Sponsor
Serene Sleep, Inc.
Study ID
NCT07613281
Status
Not Yet Recruiting

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Conditions

  • OSA - Obstructive Sleep Apnea
  • Snoring

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Palatal Implant System — DEVICE
    Serene Sleep Palatal Implant System

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Sep 30, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
26 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Snoring Group
    Implant with the Serene Sleep Palatal Implant System
  • Experimental: Mild to Moderate OSA Group
    Implant with the Serene Sleep Palatal Implant System

Primary Outcome Measure

Proportion of Participants with Implant Extrusion at 30 Days and Absence of Serious Adverse Device Effects (SADEs) [Hybrid Composite Safety Endpoint] [ Time Frame: From baseline to 30 days post-procedure ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Aesthetic Surgery CenterSan FranciscoCalifornia94102
Michael R Macdonald, MD
[email protected]
415-956-3223
Michael R Macdonald, MD (PRINCIPAL_INVESTIGATOR)
Augusta ENTEvansGeorgia30907
Jonathan P Lindman, MD
[email protected]
706-868-5676
Jonathan P Lindman, MD (PRINCIPAL_INVESTIGATOR)

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