[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07613281":3,"trial-entities:NCT07613281":115,"trial-summary:NCT07613281":118},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":43,"secondary_outcomes":48,"sex":55,"minimum_age":56,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":57,"std_ages":72,"locations":75,"central_contacts":107,"overall_officials":112,"references":113,"see_also_links":114},"NCT07613281","TESTING-055","Serene Sleep Palatal Implant System Clinical Confirmatory Trial in Participants Who Snore or Are Diagnosed With Mild-to-moderate Obstructive Sleep Apnea (OSA).","A Prospective, Non-Randomized, Multi-Center, Two-Arm Study Evaluating the Serene Sleep Palatal Implant System","NOT_YET_RECRUITING","2026-10","2026-05","2026-06-01","2026-06","Serene Sleep, Inc.","INDUSTRY",false,"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.\n\nThe 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\u002For mild-to-moderate OSA.\n\nThe 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.",null,[19,20],"Snoring","OSA - Obstructive Sleep Apnea",[19,22,23,24,25,26,27],"Obstructive Sleep Apnea","Sleep Apnea","Hypopnea","Sleep-Disordered Breathing","Sleep Implant","Airway Support Implant","INTERVENTIONAL","TREATMENT",[31],"NA",{"count":33,"type":34},26,"ESTIMATED",[36],{"type":37,"name":38,"description":39,"armGroupLabels":40},"DEVICE","Palatal Implant System","Serene Sleep Palatal Implant System",[41,42],"Mild to Moderate OSA Group","Snoring Group",[44],{"measure":45,"description":46,"timeFrame":47},"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\u002For mild-to-moderate OSA.","From baseline to 30 days post-procedure",[49,52],{"measure":50,"description":51,"timeFrame":47},"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).",{"measure":53,"description":54,"timeFrame":47},"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\u002Fsleep-disordered breathing symptoms.","ALL","18 Years",{"inclusion":58,"exclusion":68,"raw_text":71},[59,60,61,62,63,64,65,66,67],"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 \\\u003C5 would classify the participant as an eligible snoring subject","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.",[69,70],"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\u002For 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","INCLUSION CRITERIA\n\nA potential participant must meet ALL the following criteria to be enrolled into this study:\n\n1. Participant is ≥18 years of age.\n2. Participant has Body Mass Index (BMI) less than or equal to 30 kg\u002Fm²\n3. Participant has a tonsil grade less than or equal to 2\n4. Participant has a Friedman Tongue Position (FTP) I or II\n5. Participant is able to provide voluntary written informed consent.\n\nFor a snoring participant to be selected for the study:\n\n* Confirmed identification of palatal snoring\n\n  * 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.\n* Confirmed elimination of potential sleep apnea diagnosis\n\n  * If the evaluating doctor suspects that the participant may be experiencing OSA, investigators will utilize standard of care clinical assessment methods to confirm OSA.\n  * A resulting AHI \\\u003C5 would classify the participant as an eligible snoring subject\n\nFor an OSA participant to be selected for study:\n\nConfirmed identification of apnea caused by palatal collapse\n\n* Investigators should be able to make this identification through intraoral evaluation in accordance with their standard of care\n* Confirmed mild-to-moderate classification of OSA\n\n  * If the evaluating investigator knows or suspects that the participant may be experiencing OSA, standard of care diagnostic methods will be used as confirmation.\n  * A resulting AHI between 5 and 30 would classify the participant as an eligible OSA subject.\n\nEXCLUSION CRITERIA\n\nA potential participant will be excluded from enrollment if ANY of the following conditions apply:\n\n1. A record of allergic reaction to polyethylene terephthalate (PET) \u002F polyester\n2. An overly sensitive gag reflex\n3. Septal deviation or nasal obstruction\n4. Nasal polyps\n5. Severe seasonal allergies\n6. Soft palate length insufficient to accommodate implants\n7. Prior Diagnosis of Lingual tonsil hypertrophy\n8. Hypopharyngeal obstruction\n9. Previous pharyngeal surgery\n10. Previous upper respiratory tract cancer or radiation therapy\n11. Active respiratory tract infection\n12. Dysphagia or speech disorder\n13. Neurologic disorder\n14. Unstable psychiatric disorder\n15. Pregnant or breastfeeding\n16. History of falling asleep driving or Motor Vehicle Accident (MVA) due to sleepiness\n17. Clinical Presentation that suggests Severe OSAHS (ESS \\>20, participant report of choking or gasping during sleep, etc.)\n18. Marfan's Syndrome, Ehler-Danlos syndromes or other disorders of connective tissue and\u002For muscular tissue\n19. Other sleep disorders\n20. Other significant craniofacial anomaly\n21. Participant is participating in any of the following:\n\n    * A study with the same or similar primary endpoint\n    * Any study in which the investigator determines may interfere with the results of this study\n22. Participant is unwilling to complete all study related assessments and follow-up visits\n23. Participant is unwilling or unable to abstain from all alcohol consumption for 24 hours leading up to the intake sleep study\n24. Participant is unwilling or unable to abstain from all smoking, vaping, and\u002For oral tobacco products for 48 hours following the procedure\n25. Participant has any other medical condition which in the opinion of the Investigator will make participation medically unsafe or interfere with the study results",[73,74],"ADULT","OLDER_ADULT",[76,93],{"facility":77,"city":78,"state":79,"zip":80,"country":81,"contacts":82,"geoPoint":90},"Aesthetic Surgery Center","San Francisco","California","94102","United States",[83,88],{"name":84,"role":85,"phone":86,"email":87},"Michael R Macdonald, MD","CONTACT","415-956-3223","Contactus@drMMacdonald.com",{"name":84,"role":89},"PRINCIPAL_INVESTIGATOR",{"lat":91,"lon":92},37.77493,-122.41942,{"facility":94,"city":95,"state":96,"zip":97,"country":81,"contacts":98,"geoPoint":104},"Augusta ENT","Evans","Georgia","30907",[99,103],{"name":100,"role":85,"phone":101,"email":102},"Jonathan P Lindman, MD","706-868-5676","lindmanresearch@gmail.com",{"name":100,"role":89},{"lat":105,"lon":106},33.53375,-82.13067,[108],{"name":109,"role":85,"phone":110,"email":111},"Chief Technology Officer","415-707-1107","kelsey@serenesleep.com",[],[],[],{"nct_id":4,"conditions":116,"biomarkers":117},[22,19],[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]