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

Inclusion criteria

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.

Exclusion criteria

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
• 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