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

May 29, 2026 updated by: Serene Sleep, Inc.

A Prospective, Non-Randomized, Multi-Center, Two-Arm Study Evaluating the Serene Sleep Palatal Implant System

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94102
        • Aesthetic Surgery Center
        • Contact:
        • Principal Investigator:
          • Michael R Macdonald, MD
    • Georgia
      • Evans, Georgia, United States, 30907
        • Augusta ENT
        • Contact:
        • Principal Investigator:
          • Jonathan P Lindman, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Snoring Group
Implant with the Serene Sleep Palatal Implant System
Device: Palatal Implant System
Serene Sleep Palatal Implant System
Experimental: Mild to Moderate OSA Group
Implant with the Serene Sleep Palatal Implant System
Device: Palatal Implant System
Serene Sleep Palatal Implant System

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change is Visual Analogue Scale (VAS) Score
Time Frame: From baseline to 30 days post-procedure
The change in subjective snoring severity as measured by a 10 cm Visual Analogue Scale (VAS), scored 0-10, where 0 = no snoring and 10 = extremely annoying snoring (higher scores indicate worse outcome).
From baseline to 30 days post-procedure
Change in Snoring Outcomes Survey (SOS)
Time Frame: From baseline to 30 days post-procedure
The change in subjective snoring as measured by the Snoring Outcomes Survey (SOS), an 8-item validated instrument assessing intensity, duration, frequency, and impact of snoring/sleep-disordered breathing symptoms.
From baseline to 30 days post-procedure

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in daytime Epworth Sleepiness Scale (ESS)
Time Frame: From baseline to 30 days post-procedure
The change in daytime sleepiness as measured by the Epworth Sleepiness Scale (ESS), a validated 8-item questionnaire scored 0-24, where 0 = no daytime sleepiness and 24 = severe daytime sleepiness (higher scores indicate worse outcome).
From baseline to 30 days post-procedure
Change in Apnea-Hypopnea Index (bAHI3) via Home Sleep Apnea Test
Time Frame: From baseline to 30 days post-procedure
AHI Score calculated using a 3% oxygen desaturation threshold (bAHI3), collected via the Belun Sleep System HSAT device. Data will be anonymized; complete reports will be utilized as exploratory data.
From baseline to 30 days post-procedure
Change in Apnea-Hypopnea Index (bAHI4) via Home Sleep Apnea Test
Time Frame: From baseline to 30 days post-procedure
AHI Score calculated using a 4% oxygen desaturation threshold (bAHI4), collected via the Belun Sleep System HSAT device.
From baseline to 30 days post-procedure
Change in Minimum Oxygen Saturation (SpO₂) via Home Sleep Apnea Test
Time Frame: From baseline to 30 days post-procedure
Minimum SpO₂ recorded during the sleep study period, collected via the Belun Sleep System HSAT device.
From baseline to 30 days post-procedure
Change in Time with Oxygen Saturation ≤90% via Home Sleep Apnea Test
Time Frame: From baseline to 30 days post-procedure
Total cumulative duration during which SpO₂ was recorded at or below 90%, collected via the Belun Sleep System HSAT device.
From baseline to 30 days post-procedure
Change in Sleep Efficiency via Home Sleep Apnea Test
Time Frame: From baseline to 30 days post-procedure
Sleep efficiency calculated as the proportion of time in bed spent asleep, collected via the Belun Sleep System HSAT device.
From baseline to 30 days post-procedure
Change in Total Sleep Time (TST) via Home Sleep Apnea Test
Time Frame: From baseline to 30 days post-procedure
Total duration of sleep recorded during the study period, collected via the Belun Sleep System HSAT device.
From baseline to 30 days post-procedure
Change in Mean Pulse Rate via Home Sleep Apnea Test
Time Frame: From baseline to 30 days post-procedure
Mean pulse rate recorded during the sleep study period, collected via the Belun Sleep System HSAT device.
From baseline to 30 days post-procedure
Change in Arrhythmia Ratio via Home Sleep Apnea Test
Time Frame: From baseline to 30 days post-procedure
Ratio of arrhythmic heartbeats to total heartbeats recorded during the sleep study period, collected via the Belun Sleep System HSAT device
From baseline to 30 days post-procedure
Change in Auditory Evaluation of Snoring
Time Frame: From baseline to 30 days post-procedure

Outcome 6a: "Change in Objective Snoring Volume (decibels) via Audio Recording" - the change in mean snoring volume (dB) captured by at-home overnight audio recording.

Outcome 6b: "Change in Objective Snoring Frequency (Hz) via Audio Recording" - the change in dominant snoring frequency captured by at-home overnight audio recording.
From baseline to 30 days post-procedure
Proportion of Participants with Implant Migration or Trend Toward Extrusion as Assessed by Oropharyngeal Examination at 30 Days
Time Frame: Date of procedure to 30 days post-implant
At each post-procedure visit (Day 7 and Day 30), the physician will conduct a standardized oropharyngeal examination to evaluate and document whether implant location has changed from the original placement position or is trending toward extrusion. Findings will be recorded as a binary outcome (yes/no change in location) and summarized descriptively.
Date of procedure to 30 days post-implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Serene Sleep, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TESTING-055

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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