[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07132307":3,"trial-entities:NCT07132307":228,"trial-summary:NCT07132307":231},{"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":20,"study_type":24,"primary_purpose":14,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":39,"secondary_outcomes":44,"sex":72,"minimum_age":73,"maximum_age":74,"healthy_volunteers":15,"eligibility_criteria":75,"std_ages":97,"locations":100,"central_contacts":115,"overall_officials":124,"references":128,"see_also_links":227},"NCT07132307","202504015","Reducing Obstructive Sleep Apnea After Hypoglossal Nerve Stimulation Through Mandibular Advancement","Reducing Obstructive Sleep Apnea After Hypoglossal Nerve Stimulation Through","RECRUITING","2027-02-01","2026-03","2026-03-19","2025-07-29","Washington University School of Medicine","OTHER",false,"The purpose of this study is to evaluate the effectiveness, feasibility, and safety of mandibular advancement devices (MAD) for treating severe obstructive sleep apnea (OSA) in patients who are CPAP intolerant and have failed hypoglossal nerve stimulation (HGNS).","ROHMA is a pilot\u002Fsingle intervention study aiming to evaluate effectiveness of a mandibular advancement device (MAD) for treating moderate to severe obstructive sleep apnea (OSA) in patients who have failed hypoglossal nerve stimulation therapy (HGNS). Individuals who received a HGNS therapy at Washington University from April 4 2019 to October 20 2024, or were enrolled in a prior study (HRPO #: 202309014) will be recruited for the study.",[19],"Obstructive Sleep Apnea",[21,22,23],"Otolaryngology","Mandibular advancement device","Hypoglossal nerve stimulation","INTERVENTIONAL",[26],"NA",{"count":28,"type":29},30,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":37},"DEVICE","Mandibular advancement device (MAD)","The intervention in this study involves fitting and using a mandibular advancement device (MAD), specifically the ProSomnus Sleep Device, to treat moderate to severe obstructive sleep apnea (OSA) in patients who are intolerant to CPAP and have failed hypoglossal nerve stimulation (HGNS) therapy.",[36],"Mandibular Advancement Device (MAD)",[38],"ProSomnus Sleep Device.",[40],{"measure":41,"description":42,"timeFrame":43},"Proportion of responders","The proportion of responders will be defined as number of participants with more than a 50% reduction in apnea-hypopnea index (AHI) and a final AHI less than 15 (modified Sher criteria) after treatment compared to baseline, divided by the total number of participants treated with mandibular advancement device.\n\nThe AHI is a standardized index used to diagnose and determine the severity of sleep apnea. AHI will be obtained from a home sleep apnea test completed by the participants and reviewed by a trained sleep neurologist.","through study completion on average 8 weeks",[45,48,51,54,57,60,63,66,69],{"measure":46,"description":47,"timeFrame":43},"Magnitude of change in apnea-hypopnea index (AHI).","The magnitude of change in apnea-hypopnea index (AHI) refers to the difference in AHI values measured before and after using the mandibular advancement device (MAD).",{"measure":49,"description":50,"timeFrame":43},"Change in Oxygen desaturation index (ODI)","The ODI is an index used to measure the degree of oxygen desaturation during sleep. The ODI will be obtained from the sleep study results by a trained sleep neurologist.\n\nChange in ODI will be calculated as the difference ODI pre and post treatment sleep studies.",{"measure":52,"description":53,"timeFrame":43},"Change in the time spent below oxygen saturation 90%","The time spent below oxygen saturation 90% difference will be defined as the difference of the length of time where participants have an arterial saturation of oxygen below 90% during pre- and post- treatment sleep study.",{"measure":55,"description":56,"timeFrame":43},"Changes in the mean arterial oxygen saturation (SaO2)","The changes in arterial oxygen saturation (SaO2) will be defined as the difference in the mean arterial oxygen saturation recorded during pre- and post- treatment sleep studies.",{"measure":58,"description":59,"timeFrame":43},"Adherence to MAD use","Adherence is defined as using the MAD for at least 4 hours per night on at least 5 out of 7 nights during the entire intervention period.\n\nThe proportion of participants meeting this adherence criterion is calculated and reported to assess feasibility and compliance with the treatment.",{"measure":61,"description":62,"timeFrame":43},"Change in Epworth Sleepiness Scale (ESS)","The Epworth Sleepiness Scale (ESS) is measured by asking participants to rate their likelihood of falling asleep in eight different everyday situations on a scale from 1 (least likely) to 7 (most likely).\n\nThe total ESS score reflects the level of daytime sleepiness, with higher scores indicating greater sleepiness.\n\nChange in the Epworth Sleepiness Scale (ESS) is assessed by comparing participants' ESS scores before starting mandibular advancement device (MAD) therapy (baseline) with their scores after the intervention period.",{"measure":64,"description":65,"timeFrame":43},"Epworth Sleepiness Scale (ESS) improvement","The Epworth Sleepiness Scale (ESS) is measured by asking participants to rate their likelihood of falling asleep in eight different everyday situations on a scale from 1 (least likely) to 7 (most likely).\n\nThe total ESS score reflects the level of daytime sleepiness, with higher scores indicating greater sleepiness.\n\nChange in the Epworth Sleepiness Scale (ESS) is assessed by comparing participants' ESS scores before starting mandibular advancement device (MAD) therapy (baseline) with their scores after the intervention period.\n\nThe proportion of participants with improved ESS will be calculated as number of participants whose ESS score changes exceed the minimal clinically important difference (MCID) of 2.4 points divided by the total number of participants.",{"measure":67,"description":68,"timeFrame":43},"Symptoms of Nocturnal Obstruction and Related Events (SNORE-25)","The Symptoms of Nocturnal Obstruction and Related Events (SNORE-25) is a validated 25-item questionnaire used to assess sleep-disorder related morbidity by capturing the frequency and severity of symptoms associated with obstructive sleep apnea. The total score ranges from 0 to 5, with higher scores indicating a greater health burden related to sleep-disordered breathing.\n\nChange in the Symptoms of Nocturnal Obstruction and Related Events (SNORE-25) scale is assessed by comparing participants' SNORE-25 scores before starting mandibular advancement device (MAD) therapy with their scores after completing the intervention period.",{"measure":70,"description":71,"timeFrame":43},"Clinical Global Impression of Improvement (CGI-I) Scale","The Clinical Global Impression of Improvement (CGI-I) scale is a validated, widely used tool that asks participants to rate their overall response to a treatment-in this case, mandibular advancement device (MAD) therapy for obstructive sleep apnea.\n\nParticipants select one of seven response options: Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse, or Very Much Worse. The proportion of participants reporting improvement is defined as those who choose \"Much Improved\" or \"Very Much Improved\" divided by the total number of participants completing the study.","ALL","18 Years","70 Years",{"inclusion":76,"exclusion":84,"raw_text":96},[77,78,79,80,81,82,83],"Age ≥ 18 years.","Ability to read, write, speak, and understand English.","Failure of hypoglossal nerve stimulation (HGNS) therapy, defined as intolerance to HGNS or insufficient AHI reduction based on modified Sher criteria while using HGNS.","Ability to insert and remove the mandibular advancement device (MAD) independently.","Ability to complete all study assessments and evaluations, including home sleep apnea tests (HSAT).","Ability to abstain from any other treatment for obstructive sleep apnea (OSA) during the entire study duration.","Access to an internet-connected device (phone, tablet, or laptop) with a camera.",[85,86,87,88,89,90,91,92,93,94,95],"Age over 70 years.","Inability to use a mandibular advancement device (MAD), defined as having fewer than 9 healthy teeth per dental arch.","Prior intolerance to MAD therapy.","Previous participation in a trial involving the use of oral appliances.","Chronic nasal obstruction.","Dependence on or frequent use of medications that alter consciousness, respiration, or alertness.","Insomnia and\u002For use of medications to treat insomnia.","Sleep disorders such as narcolepsy, insomnia, restless leg syndrome, or other disorders affecting sleep, and\u002For use of medications to treat such disorders.","Substance abuse.","Unstable psychiatric disorders.","Current use of a GLP-1 receptor agonist (e.g., Zepbound, Wegovy, Ozempic, Mounjaro) with ongoing, active weight loss at the time of enrollment, or recent dose escalation within the prior 8 weeks.","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Ability to read, write, speak, and understand English.\n* Failure of hypoglossal nerve stimulation (HGNS) therapy, defined as intolerance to HGNS or insufficient AHI reduction based on modified Sher criteria while using HGNS.\n* Ability to insert and remove the mandibular advancement device (MAD) independently.\n* Ability to complete all study assessments and evaluations, including home sleep apnea tests (HSAT).\n* Ability to abstain from any other treatment for obstructive sleep apnea (OSA) during the entire study duration.\n* Access to an internet-connected device (phone, tablet, or laptop) with a camera.\n\nExclusion Criteria:\n\n* Age over 70 years.\n* Inability to use a mandibular advancement device (MAD), defined as having fewer than 9 healthy teeth per dental arch.\n* Prior intolerance to MAD therapy.\n* Previous participation in a trial involving the use of oral appliances.\n* Chronic nasal obstruction.\n* Dependence on or frequent use of medications that alter consciousness, respiration, or alertness.\n* Insomnia and\u002For use of medications to treat insomnia.\n* Sleep disorders such as narcolepsy, insomnia, restless leg syndrome, or other disorders affecting sleep, and\u002For use of medications to treat such disorders.\n* Substance abuse.\n* Unstable psychiatric disorders.\n* Current use of a GLP-1 receptor agonist (e.g., Zepbound, Wegovy, Ozempic, Mounjaro) with ongoing, active weight loss at the time of enrollment, or recent dose escalation within the prior 8 weeks.",[98,99],"ADULT","OLDER_ADULT",[101],{"facility":13,"status":8,"city":102,"state":103,"zip":104,"country":105,"contacts":106,"geoPoint":112},"St Louis","Missouri","63110","United States",[107],{"name":108,"role":109,"phone":110,"email":111},"Sara Kukuljan, BS, RN","CONTACT","314-362-7563","kukuljans@ent.wustl.edu",{"lat":113,"lon":114},38.62727,-90.19789,[116,120],{"name":117,"role":109,"phone":118,"email":119},"Jay F Piccirillo, MD","314-362-8641","piccirj@wustl.edu",{"name":121,"role":109,"phone":122,"email":123},"Sara Kukuljan","314-362-7653","kukuljas@wustl.edu",[125],{"name":126,"affiliation":13,"role":127},"Jay Piccirillo, MD","PRINCIPAL_INVESTIGATOR",[129,133,136,139,142,145,148,151,154,157,160,163,166,169,172,175,178,181,184,187,190,193,196,199,202,205,208,211,214,217,220,223],{"pmid":130,"type":131,"citation":132},"31999308","BACKGROUND","Skirko JR, James KT, Garrison LP, Weaver EM. Development of a Sleep Apnea-Specific Health State Utility Algorithm. JAMA Otolaryngol Head Neck Surg. 2020 Mar 1;146(3):270-277. doi: 10.1001\u002Fjamaoto.2019.4469.",{"pmid":134,"type":131,"citation":135},"30255301","Wojda M, Kostrzewa-Janicka J, Sliwinski P, Bielen P, Jurkowski P, Wojda R, Mierzwinska-Nastalska E. Mandibular Advancement Devices in Obstructive Sleep Apnea Patients Intolerant to Continuous Positive Airway Pressure Treatment. Adv Exp Med Biol. 2019;1150:35-42. doi: 10.1007\u002F5584_2018_275.",{"pmid":137,"type":131,"citation":138},"34381578","Abbasi A, Gupta SS, Sabharwal N, Meghrajani V, Sharma S, Kamholz S, Kupfer Y. A comprehensive review of obstructive sleep apnea. Sleep Sci. 2021 Apr-Jun;14(2):142-154. doi: 10.5935\u002F1984-0063.20200056.",{"pmid":140,"type":131,"citation":141},"26380759","Franklin KA, Lindberg E. Obstructive sleep apnea is a common disorder in the population-a review on the epidemiology of sleep apnea. J Thorac Dis. 2015 Aug;7(8):1311-22. doi: 10.3978\u002Fj.issn.2072-1439.2015.06.11.",{"pmid":143,"type":131,"citation":144},"32344992","Woo HJ, Lim JH, Ahn JC, Lee YJ, Kim DY, Kim HJ, Rhee CS, Won TB. Characteristics of Obstructive Sleep Apnea Patients With a Low Body Mass Index: Emphasis on the Obstruction Site Determined by Drug-Induced Sleep Endoscopy. Clin Exp Otorhinolaryngol. 2020 Nov;13(4):415-421. doi: 10.21053\u002Fceo.2019.00794. Epub 2020 Apr 29.",{"pmid":146,"type":131,"citation":147},"32511760","Wong SJ, Luitje ME, Karelsky S. Patterns of Obstruction on DISE in Adults With Obstructive Sleep Apnea Change With BMI. Laryngoscope. 2021 Jan;131(1):224-229. doi: 10.1002\u002Flary.28777. Epub 2020 Jun 8.",{"pmid":149,"type":131,"citation":150},"37230968","Lv R, Liu X, Zhang Y, Dong N, Wang X, He Y, Yue H, Yin Q. Pathophysiological mechanisms and therapeutic approaches in obstructive sleep apnea syndrome. Signal Transduct Target Ther. 2023 May 25;8(1):218. doi: 10.1038\u002Fs41392-023-01496-3.",{"pmid":152,"type":131,"citation":153},"35273554","Kazemeini E, Van de Perck E, Dieltjens M, Willemen M, Verbraecken J, Op de Beeck S, Vanderveken OM. Critical to Know Pcrit: A Review on Pharyngeal Critical Closing Pressure in Obstructive Sleep Apnea. Front Neurol. 2022 Feb 22;13:775709. doi: 10.3389\u002Ffneur.2022.775709. eCollection 2022.",{"pmid":155,"type":131,"citation":156},"27542595","Rotenberg BW, Murariu D, Pang KP. Trends in CPAP adherence over twenty years of data collection: a flattened curve. J Otolaryngol Head Neck Surg. 2016 Aug 19;45(1):43. doi: 10.1186\u002Fs40463-016-0156-0.",{"pmid":158,"type":131,"citation":159},"21061864","Aurora RN, Casey KR, Kristo D, Auerbach S, Bista SR, Chowdhuri S, Karippot A, Lamm C, Ramar K, Zak R, Morgenthaler TI; American Academy of Sleep Medicine. Practice parameters for the surgical modifications of the upper airway for obstructive sleep apnea in adults. Sleep. 2010 Oct;33(10):1408-13. doi: 10.1093\u002Fsleep\u002F33.10.1408.",{"pmid":161,"type":131,"citation":162},"31520484","Thaler E, Schwab R, Maurer J, Soose R, Larsen C, Stevens S, Stevens D, Boon M, Huntley C, Doghramji K, Waters T, Kominsky A, Steffen A, Kezirian E, Hofauer B, Sommer U, Withrow K, Strohl K, Heiser C. Results of the ADHERE upper airway stimulation registry and predictors of therapy efficacy. Laryngoscope. 2020 May;130(5):1333-1338. doi: 10.1002\u002Flary.28286. Epub 2019 Sep 14.",{"pmid":164,"type":131,"citation":165},"33572156","Mashaqi S, Patel SI, Combs D, Estep L, Helmick S, Machamer J, Parthasarathy S. The Hypoglossal Nerve Stimulation as a Novel Therapy for Treating Obstructive Sleep Apnea-A Literature Review. Int J Environ Res Public Health. 2021 Feb 9;18(4):1642. doi: 10.3390\u002Fijerph18041642.",{"pmid":167,"type":131,"citation":168},"24033656","Kezirian EJ, Goding GS Jr, Malhotra A, O'Donoghue FJ, Zammit G, Wheatley JR, Catcheside PG, Smith PL, Schwartz AR, Walsh JH, Maddison KJ, Claman DM, Huntley T, Park SY, Campbell MC, Palme CE, Iber C, Eastwood PR, Hillman DR, Barnes M. Hypoglossal nerve stimulation improves obstructive sleep apnea: 12-month outcomes. J Sleep Res. 2014 Feb;23(1):77-83. doi: 10.1111\u002Fjsr.12079. Epub 2013 Sep 4.",{"pmid":170,"type":131,"citation":171},"23674933","Vanderveken OM, Maurer JT, Hohenhorst W, Hamans E, Lin HS, Vroegop AV, Anders C, de Vries N, Van de Heyning PH. Evaluation of drug-induced sleep endoscopy as a patient selection tool for implanted upper airway stimulation for obstructive sleep apnea. J Clin Sleep Med. 2013 May 15;9(5):433-8. doi: 10.5664\u002Fjcsm.2658.",{"pmid":173,"type":131,"citation":174},"35371398","Manetta IP, Ettlin D, Sanz PM, Rocha I, Meira E Cruz M. Mandibular advancement devices in obstructive sleep apnea: an updated review. Sleep Sci. 2022 Apr-Jun;15(Spec 2):398-405. doi: 10.5935\u002F1984-0063.20210032.",{"pmid":176,"type":131,"citation":177},"20299246","Chung JW, Enciso R, Levendowski DJ, Morgan TD, Westbrook PR, Clark GT. Treatment outcomes of mandibular advancement devices in positional and nonpositional OSA patients. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 May;109(5):724-31. doi: 10.1016\u002Fj.tripleo.2009.11.031. Epub 2010 Mar 17.",{"pmid":179,"type":131,"citation":180},"25142766","Dieltjens M, Braem MJ, Van de Heyning PH, Wouters K, Vanderveken OM. Prevalence and clinical significance of supine-dependent obstructive sleep apnea in patients using oral appliance therapy. J Clin Sleep Med. 2014 Sep 15;10(9):959-64. doi: 10.5664\u002Fjcsm.4024.",{"pmid":182,"type":131,"citation":183},"15078734","Marklund M, Stenlund H, Franklin KA. Mandibular advancement devices in 630 men and women with obstructive sleep apnea and snoring: tolerability and predictors of treatment success. Chest. 2004 Apr;125(4):1270-8. doi: 10.1378\u002Fchest.125.4.1270.",{"pmid":185,"type":131,"citation":186},"34165074","Vecchierini MF, Attali V, Collet JM, d'Ortho MP, Goutorbe F, Kerbrat JB, Leger D, Lavergne F, Monaca C, Monteyrol PJ, Mullens E, Pigearias B, Martin F, Khemliche H, Lerousseau L, Meurice JC. Mandibular advancement device use in obstructive sleep apnea: ORCADES study 5-year follow-up data. J Clin Sleep Med. 2021 Aug 1;17(8):1695-1705. doi: 10.5664\u002Fjcsm.9308.",{"pmid":188,"type":131,"citation":189},"8855039","Sher AE, Schechtman KB, Piccirillo JF. The efficacy of surgical modifications of the upper airway in adults with obstructive sleep apnea syndrome. Sleep. 1996 Feb;19(2):156-77. doi: 10.1093\u002Fsleep\u002F19.2.156.",{"pmid":191,"type":131,"citation":192},"30518456","Rosen IM, Kirsch DB, Carden KA, Malhotra RK, Ramar K, Aurora RN, Kristo DA, Martin JL, Olson EJ, Rosen CL, Rowley JA, Shelgikar AV; American Academy of Sleep Medicine Board of Directors. Clinical Use of a Home Sleep Apnea Test: An Updated American Academy of Sleep Medicine Position Statement. J Clin Sleep Med. 2018 Dec 15;14(12):2075-2077. doi: 10.5664\u002Fjcsm.7540.",{"pmid":194,"type":131,"citation":195},"33693939","Malhotra A, Ayappa I, Ayas N, Collop N, Kirsch D, Mcardle N, Mehra R, Pack AI, Punjabi N, White DP, Gottlieb DJ. Metrics of sleep apnea severity: beyond the apnea-hypopnea index. Sleep. 2021 Jul 9;44(7):zsab030. doi: 10.1093\u002Fsleep\u002Fzsab030.",{"pmid":197,"type":131,"citation":198},"10718409","Piccirillo JF. Outcomes research and obstructive sleep apnea. Laryngoscope. 2000 Mar;110(3 Pt 3):16-20. doi: 10.1097\u002F00005537-200003002-00005.",{"pmid":200,"type":131,"citation":201},"29988275","Temirbekov D, Gunes S, Yazici ZM, Sayin I. The Ignored Parameter in the Diagnosis of Obstructive Sleep Apnea Syndrome: The Oxygen Desaturation Index. Turk Arch Otorhinolaryngol. 2018 Mar;56(1):1-6. doi: 10.5152\u002Ftao.2018.3025. Epub 2018 Mar 1.",{"pmid":203,"type":131,"citation":204},"32333683","Rashid NH, Zaghi S, Scapuccin M, Camacho M, Certal V, Capasso R. The Value of Oxygen Desaturation Index for Diagnosing Obstructive Sleep Apnea: A Systematic Review. Laryngoscope. 2021 Feb;131(2):440-447. doi: 10.1002\u002Flary.28663. Epub 2020 Apr 25.",{"pmid":206,"type":131,"citation":207},"35613672","Jacobowitz O, Schwartz AR, Lovett EG, Ranuzzi G, Malhotra A. Design and rationale for the treating Obstructive Sleep Apnea using Targeted Hypoglossal Nerve Stimulation (OSPREY) trial. Contemp Clin Trials. 2022 Aug;119:106804. doi: 10.1016\u002Fj.cct.2022.106804. Epub 2022 May 22.",{"pmid":209,"type":131,"citation":210},"36536636","Scharf MT. Reliability and Efficacy of the Epworth Sleepiness Scale: Is There Still a Place for It? Nat Sci Sleep. 2022 Dec 13;14:2151-2156. doi: 10.2147\u002FNSS.S340950. eCollection 2022.",{"pmid":212,"type":131,"citation":213},"1798888","Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093\u002Fsleep\u002F14.6.540.",{"pmid":215,"type":131,"citation":216},"33326914","De Meyer MMD, Vanderveken OM, De Weerdt S, Marks LAM, Carcamo BA, Chavez AM, Matamoros FA, Jacquet W. Use of mandibular advancement devices for the treatment of primary snoring with or without obstructive sleep apnea (OSA): A systematic review. Sleep Med Rev. 2021 Apr;56:101407. doi: 10.1016\u002Fj.smrv.2020.101407. Epub 2020 Nov 29.",{"pmid":218,"type":131,"citation":219},"17921053","Smith SS, Oei TP, Douglas JA, Brown I, Jorgensen G, Andrews J. Confirmatory factor analysis of the Epworth Sleepiness Scale (ESS) in patients with obstructive sleep apnoea. Sleep Med. 2008 Oct;9(7):739-44. doi: 10.1016\u002Fj.sleep.2007.08.004. Epub 2007 Oct 24.",{"pmid":221,"type":131,"citation":222},"20526405","Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007 Jul;4(7):28-37.",{"pmid":224,"type":225,"citation":226},"33039197","RESULT","Hsu YB, Lan MY, Huang YC, Huang TT, Lan MC. The correlation between drug-induced sleep endoscopy findings and severity of obstructive sleep apnea. Auris Nasus Larynx. 2021 Jun;48(3):434-440. doi: 10.1016\u002Fj.anl.2020.09.018. Epub 2020 Oct 7.",[],{"nct_id":4,"conditions":229,"biomarkers":230},[19],[],{"nct_id":4,"found":232,"summary":233,"prompt_version":243},true,{"design":234,"status":235,"heading":236,"summary":237,"follow_up":238,"word_count":239,"commitments":240,"compensation":241,"drugs_mentioned":242},"This is a pilot study involving 30 participants. It is a single-intervention study, meaning all participants will receive the mandibular advancement device.","completed","Mandibular Advancement for Obstructive Sleep Apnea After Failed Hypoglossal Nerve Stimulation","This study is looking at how well a device called a mandibular advancement device (MAD), specifically the ProSomnus Sleep Device, works for people with moderate to severe obstructive sleep apnea (OSA). This is for individuals who haven't found relief with CPAP (continuous positive airway pressure) and whose hypoglossal nerve stimulation (HGNS) therapy has not been successful. The study aims to see if the MAD can effectively treat OSA in these patients. You might be able to join if you are 18 or older, can speak English, and have failed HGNS therapy. Success in this study will be measured by the proportion of participants who respond to the treatment, typically over about 8 weeks. The current recruitment status is unclear.","The primary outcome will be measured through study completion, on average 8 weeks after starting the intervention.",119,"The intervention involves fitting and using a mandibular advancement device. Participants must be able to insert and remove the device independently.","Not stated in the trial record.",[33],"v2"]