An interventional study of Palatal Implant System in Snoring and OSA - Obstructive Sleep Apnea, sponsored by Serene Sleep, Inc.. Not yet recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-01.
Sponsored by Serene Sleep, Inc. · Not applicable, Interventional, and Treatment
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.
122 studies on the registry are indexed under Snoring; 15 are open to participants now.
This study's planned enrollment of 26 is below the median of 43 across 95 interventional studies indexed under Snoring.
Browse Snoring studies →This is the only study on the registry with Serene Sleep, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
A potential participant must meet ALL the following criteria to be enrolled into this study:
For a snoring participant to be selected for the study:
Confirmed identification of palatal snoring
Confirmed elimination of potential sleep apnea diagnosis
For an OSA participant to be selected for study:
Confirmed identification of apnea caused by palatal collapse
Confirmed mild-to-moderate classification of OSA
EXCLUSION CRITERIA
A potential participant will be excluded from enrollment if ANY of the following conditions apply:
Participant is participating in any of the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Implant with the Serene Sleep Palatal Implant System
Device: Palatal Implant System
Implant with the Serene Sleep Palatal Implant System
Device: Palatal Implant System
Serene Sleep Palatal Implant System
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.
Time frame: From baseline to 30 days post-procedure
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).
Time frame: 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.
Time frame: From baseline to 30 days post-procedure
Change in daytime Epworth Sleepiness Scale (ESS)
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).
Time frame: From baseline to 30 days post-procedure
Change in Apnea-Hypopnea Index (bAHI3) via Home Sleep Apnea Test
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.
Time frame: From baseline to 30 days post-procedure
Change in Apnea-Hypopnea Index (bAHI4) via Home Sleep Apnea Test
AHI Score calculated using a 4% oxygen desaturation threshold (bAHI4), collected via the Belun Sleep System HSAT device.
Time frame: From baseline to 30 days post-procedure
Change in Minimum Oxygen Saturation (SpO₂) via Home Sleep Apnea Test
Minimum SpO₂ recorded during the sleep study period, collected via the Belun Sleep System HSAT device.
Time frame: From baseline to 30 days post-procedure
Change in Time with Oxygen Saturation ≤90% via Home Sleep Apnea Test
Total cumulative duration during which SpO₂ was recorded at or below 90%, collected via the Belun Sleep System HSAT device.
Time frame: From baseline to 30 days post-procedure
Change in Sleep Efficiency via Home Sleep Apnea Test
Sleep efficiency calculated as the proportion of time in bed spent asleep, collected via the Belun Sleep System HSAT device.
Time frame: From baseline to 30 days post-procedure
Change in Total Sleep Time (TST) via Home Sleep Apnea Test
Total duration of sleep recorded during the study period, collected via the Belun Sleep System HSAT device.
Time frame: From baseline to 30 days post-procedure
Change in Mean Pulse Rate via Home Sleep Apnea Test
Mean pulse rate recorded during the sleep study period, collected via the Belun Sleep System HSAT device.
Time frame: From baseline to 30 days post-procedure
Change in Arrhythmia Ratio via Home Sleep Apnea Test
Ratio of arrhythmic heartbeats to total heartbeats recorded during the sleep study period, collected via the Belun Sleep System HSAT device
Time frame: From baseline to 30 days post-procedure
Change in Auditory Evaluation of Snoring
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.
Time frame: 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
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.
Time frame: Date of procedure to 30 days post-implant
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jun 2026; primary completion for Sep 2026, 3 months later.
Of 45 interventional studies with no phase under Snoring, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 31. This study's planned 3 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.