SnoringNCT07613281
Serene Sleep Palatal Implant System Clinical Confirmatory Trial in Participants Who Snore or Are Diagnosed With Mild-to-moderate Obstructive Sleep Apnea (OSA).
A study testing Palatal Implant System in people with Snoring and OSA - Obstructive Sleep Apnea, run by Serene Sleep, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Snoring, OSA - Obstructive Sleep Apnea
- What is being tested?
- Palatal Implant System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2026to Oct 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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
- Pregnant or breastfeeding
- History of falling asleep driving or Motor Vehicle Accident (MVA) due to sleepiness
- Clinical Presentation that suggests Severe OSAHS (ESS >20, participant report of choking or gasping during sleep, etc.)
- Marfan's Syndrome, Ehler-Danlos syndromes or other disorders of connective tissue and/or muscular tissue
- Other sleep disorders
- Other significant craniofacial anomaly
- 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
- Participant is unwilling to complete all study related assessments and follow-up visits
- Participant is unwilling or unable to abstain from all alcohol consumption for 24 hours leading up to the intake sleep study
- Participant is unwilling or unable to abstain from all smoking, vaping, and/or oral tobacco products for 48 hours following the procedure
- Participant has any other medical condition which in the opinion of the Investigator will make participation medically unsafe or interfere with the study results
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Augusta ENT
Evans, Georgia, 30907
Jonathan P Lindman, MD, 706-868-5676, lindmanresearch@gmail.com
Jonathan P Lindman, MD
Aesthetic Surgery Center
San Francisco, California, 94102
Michael R Macdonald, MD, 415-956-3223, Contactus@drMMacdonald.com
Michael R Macdonald, MD
About this study
Official title: 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.
- Conditions
- Snoring, OSA - Obstructive Sleep Apnea
- Being tested
- Palatal Implant System
- Keywords
- Snoring, Obstructive Sleep Apnea, Sleep Apnea, Hypopnea, Sleep-Disordered Breathing, Sleep Implant, Airway Support Implant
- Medical subject headings
- Snoring, Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palatal Implant SystemDevice
Serene Sleep Palatal Implant System
| Study group | Role | What they receive |
|---|---|---|
| Snoring Group | Experimental | Implant with the Serene Sleep Palatal Implant System Receives: Device: Palatal Implant System |
| Mild to Moderate OSA Group | Experimental | Implant with the Serene Sleep Palatal Implant System Receives: Device: Palatal Implant System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 30 days post-procedure
Secondary outcomes (2)
Change is Visual Analogue Scale (VAS) Score
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).
Measured: From baseline to 30 days post-procedure
Change in Snoring Outcomes Survey (SOS)
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.
Measured: From baseline to 30 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study startJun 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SnoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Serene Sleep, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07613281
- Sponsor's protocol ID
- TESTING-055
- Status last verified
- May 2026
- First submitted
- 3 Nov 2025
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No