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:

1. Participant is ≥18 years of age.
2. Participant has Body Mass Index (BMI) less than or equal to 30 kg/m²
3. Participant has a tonsil grade less than or equal to 2
4. Participant has a Friedman Tongue Position (FTP) I or II
5. 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:

1. A record of allergic reaction to polyethylene terephthalate (PET) / polyester
2. An overly sensitive gag reflex
3. Septal deviation or nasal obstruction
4. Nasal polyps
5. Severe seasonal allergies
6. Soft palate length insufficient to accommodate implants
7. Prior Diagnosis of Lingual tonsil hypertrophy
8. Hypopharyngeal obstruction
9. Previous pharyngeal surgery
10. Previous upper respiratory tract cancer or radiation therapy
11. Active respiratory tract infection
12. Dysphagia or speech disorder
13. Neurologic disorder
14. Unstable psychiatric disorder
15. Pregnant or breastfeeding
16. History of falling asleep driving or Motor Vehicle Accident (MVA) due to sleepiness
17. Clinical Presentation that suggests Severe OSAHS (ESS >20, participant report of choking or gasping during sleep, etc.)
18. Marfan's Syndrome, Ehler-Danlos syndromes or other disorders of connective tissue and/or muscular tissue
19. Other sleep disorders
20. Other significant craniofacial anomaly

21. 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
22. Participant is unwilling to complete all study related assessments and follow-up visits
23. Participant is unwilling or unable to abstain from all alcohol consumption for 24 hours leading up to the intake sleep study
24. Participant is unwilling or unable to abstain from all smoking, vaping, and/or oral tobacco products for 48 hours following the procedure
25. Participant has any other medical condition which in the opinion of the Investigator will make participation medically unsafe or interfere with the study results