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

NCT07613281 | Not Yet Recruiting FDA Device

• 1 other identifier: TESTING-055
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Snoring; OSA - Obstructive Sleep Apnea

Keywords

Snoring; Obstructive Sleep Apnea; Sleep Apnea; Hypopnea; Sleep-Disordered Breathing; Sleep Implant; Airway Support Implant

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants with Implant Extrusion at 30 Days and Absence of Serious Adverse Device Effects (SADEs) [Hybrid Composite Safety Endpoint]

  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.

  From baseline to 30 days post-procedure

Secondary Outcomes (2)

• Change is Visual Analogue Scale (VAS) Score

  From baseline to 30 days post-procedure

• Change in Snoring Outcomes Survey (SOS)

  From baseline to 30 days post-procedure

Other Outcomes (11)

• Change in daytime Epworth Sleepiness Scale (ESS)

  From baseline to 30 days post-procedure

• Change in Apnea-Hypopnea Index (bAHI3) via Home Sleep Apnea Test

  From baseline to 30 days post-procedure

• Change in Apnea-Hypopnea Index (bAHI4) via Home Sleep Apnea Test

  From baseline to 30 days post-procedure

Study Arms (2)

Snoring Group

EXPERIMENTAL

Implant with the Serene Sleep Palatal Implant System

Device: Palatal Implant System

Mild to Moderate OSA Group

EXPERIMENTAL

Implant with the Serene Sleep Palatal Implant System

Device: Palatal Implant System

Interventions

Palatal Implant System DEVICE

Serene Sleep Palatal Implant System

Mild to Moderate OSA Group; Snoring Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A potential participant must meet ALL the following criteria to be enrolled into this study:
• Participant is ≥18 years of age.
• Participant has Body Mass Index (BMI) less than or equal to 30 kg/m²
• Participant has a tonsil grade less than or equal to 2
• Participant has a Friedman Tongue Position (FTP) I or II
• 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

You may not qualify if:

• A potential participant will be excluded from enrollment if ANY of the following conditions apply:
• A record of allergic reaction to polyethylene terephthalate (PET) / polyester
• An overly sensitive gag reflex
• Septal deviation or nasal obstruction
• Nasal polyps
• Severe seasonal allergies
• Soft palate length insufficient to accommodate implants
• Prior Diagnosis of Lingual tonsil hypertrophy
• Hypopharyngeal obstruction
• Previous pharyngeal surgery
• Previous upper respiratory tract cancer or radiation therapy
• Active respiratory tract infection
• Dysphagia or speech disorder
• Neurologic disorder
• Unstable psychiatric disorder

Sponsors & Collaborators

• Serene Sleep, Inc.: lead

Study Sites (2)

Aesthetic Surgery Center

San Francisco, California, 94102, United States

Location

Augusta ENT

Evans, Georgia, 30907, United States

Location

MeSH Terms

Conditions

Snoring; Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Chief Technology Officer

CONTACT

415-707-1107; kelsey@serenesleep.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2025
• First Posted: May 29, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)