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.
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
A record of allergic reaction to polyethylene terephthalate (PET) / polyester
An overly sensitive gag reflex
Septal deviation or nasal obstruction
Nasal polyps
Parallel
Palatal Implant System
DeviceSerene 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.
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).
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.
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).
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.
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.
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.
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