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

Who can take part

• 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
• 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 take part

• Soft palate length insufficient to accommodate implants
• Prior Diagnosis of Lingual tonsil hypertrophy
• Previous pharyngeal surgery
• Previous upper respiratory tract cancer or radiation therapy
• 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
• Severe seasonal allergies
• Active respiratory tract infection
• Dysphagia or speech disorder
• Neurologic disorder
• Unstable psychiatric disorder
• History of falling asleep driving or Motor Vehicle Accident (MVA) due to sleepiness
• Marfan's Syndrome, Ehler-Danlos syndromes or other disorders of connective tissue and/or muscular tissue
• Other sleep disorders
• Participant has any other medical condition which in the opinion of the Investigator will make participation medically unsafe or interfere with the study results
• An overly sensitive gag reflex
• Septal deviation or nasal obstruction
• Nasal polyps
• Hypopharyngeal obstruction
• Pregnant or breastfeeding
• Clinical Presentation that suggests Severe OSAHS (ESS >20, participant report of choking or gasping during sleep, etc.)
• 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