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

Официальное название

A Prospective, Non-Randomized, Multi-Center, Two-Arm Study Evaluating the Serene Sleep Palatal Implant System

Обзор

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.

Вмешательства

• Устройство Palatal Implant System
  Serene Sleep Palatal Implant System

Первичные конечные точки

• Proportion of Participants with Implant Extrusion at 30 Days and Absence of Serious Adverse Device Effects (SADEs) [Hybrid Composite Safety Endpoint] [Срок оценки: From baseline to 30 days post-procedure]

Вторичные конечные точки (2)

• Change is Visual Analogue Scale (VAS) Score [Срок оценки: From baseline to 30 days post-procedure]
• Change in Snoring Outcomes Survey (SOS) [Срок оценки: From baseline to 30 days post-procedure]

Критерии участия

Критерии включения

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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Aesthetic Surgery Center — San Francisco
• Augusta ENT — Evans

Идентификаторы

NCT: NCT07613281 · TESTING-055

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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