Surgical Treatment for Patients With Obstructive Sleep Apnea by Using Da Vinci SP Surgical System
NCT ID: NCT06766760
Last Updated: 2025-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
25 participants
INTERVENTIONAL
2025-01-01
2026-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Treatment of Obstructive Sleep Apnea (OSA) With the da Vinci® SP™ Surgical System
NCT04795817
Transoral Robotic Surgery (TORS) for Sleep Apnea
NCT01187160
Precision Health and Smart Telerehabilitation in OSA
NCT07254026
Myofunctional Training for Obstructive Sleep Apnea Patients After Transoral Robotic Surgery
NCT04876482
Developing a Treatment Clustering System for Obstructive Sleep Apnea Using Polysomnographic Physiological Signals
NCT06512779
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Informed consent will be provided to patient who has an indication of surgical treatment for OSA. Study participants will sign an informed consent before any study procedure begins. Eligibilities will be assessed during screening period (2 weeks) with blood test and other routine assessments. Eligible patient will undergo surgical intervention using da Vinci SP Surgical System. Post-operation follow-up will be performed at 1 week, 1 month, 3 months, and 6 months.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
OSAS with SP Da Vinci
Da Vinci SP Surgical System, Model SP1098
The da Vinci SP Surgical System is intended to assist in the accurate control of the da Vinci SP endoscope and instruments during minimally invasive endoscopic abdominopelvic, thoracoscopic, transoral otolaryngology, and breast surgical procedures. The system is indicated for adult use. It is intended to be used by trained physicians in an operating room environment.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Da Vinci SP Surgical System, Model SP1098
The da Vinci SP Surgical System is intended to assist in the accurate control of the da Vinci SP endoscope and instruments during minimally invasive endoscopic abdominopelvic, thoracoscopic, transoral otolaryngology, and breast surgical procedures. The system is indicated for adult use. It is intended to be used by trained physicians in an operating room environment.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. OSA with AHI ≥ 15
3. Has failed, refuses, or is unable to tolerate CPAP therapy
4. Indication of resection of tongue base with/without other invasive surgical procedure for OSA (i.e. tongue base resection only or multi-level surgery with tongue base resection)
5. ASA physical status classification 1-2 and adequate organ function
6. Patients willing and able to comply with study protocol requirements and follow-up
7. Informed consent
Exclusion Criteria
2. Mouth opening too narrow for TORS or trismus
3. Betel nut chewing
4. Suspicious cancer diagnosis
5. Prior head-and-neck surgery (note: prior invasive therapy for OSA allowed)
6. Other medical condition or anatomical factor not suitable for TORS, including subject with congenital malformations in the larynx, throat or tongue; 1. Subject with an American Society of Anesthesiologists (ASA) score of Grade 4 or above during preoperative evaluation
7. Active infectious disease
8. Can't follow trial-required procedures
9. Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions
* Severe heart disease (NYHA functional class III-IV)
* Severe lung disease (GOLD Group C-D)
10. Long-term use of anti-coagulant
11. Patients with coagulopathy
12. Emergency surgery
13. Subject for whom any additional surgeries are planned for OSA within the study period, after the surgery in which the da Vinci SP System was used
14. Subject is pregnant or suspected to be pregnant
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chang Gung Memorial Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Linkou Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Costantino A, Sampieri C, Meliante PG, De Virgilio A, Kim SH. Transoral robotic surgery in oropharyngeal squamous cell carcinoma: A comparative study between da Vinci Single-Port and da Vinci Xi systems. Oral Oncol. 2024 Jan;148:106629. doi: 10.1016/j.oraloncology.2023.106629. Epub 2023 Nov 14.
Baptista PM, Diaz Zufiaurre N, Garaycochea O, Alcalde Navarrete JM, Moffa A, Giorgi L, Casale M, O'Connor-Reina C, Plaza G. TORS as Part of Multilevel Surgery in OSA: The Importance of Careful Patient Selection and Outcomes. J Clin Med. 2022 Feb 14;11(4):990. doi: 10.3390/jcm11040990.
Lin HC, Friedman M. Transoral robotic OSA surgery. Auris Nasus Larynx. 2021 Jun;48(3):339-346. doi: 10.1016/j.anl.2020.08.025. Epub 2020 Sep 8.
Park YM, Kim DH, Kang MS, Lim JY, Choi EC, Koh YW, Kim SH. The First Human Trial of Transoral Robotic Surgery Using a Single-Port Robotic System in the Treatment of Laryngo-Pharyngeal Cancer. Ann Surg Oncol. 2019 Dec;26(13):4472-4480. doi: 10.1245/s10434-019-07802-0. Epub 2019 Sep 9.
Holsinger FC. A flexible, single-arm robotic surgical system for transoral resection of the tonsil and lateral pharyngeal wall: Next-generation robotic head and neck surgery. Laryngoscope. 2016 Apr;126(4):864-9. doi: 10.1002/lary.25724. Epub 2015 Oct 28.
Chen MM, Orosco RK, Lim GC, Holsinger FC. Improved transoral dissection of the tongue base with a next-generation robotic surgical system. Laryngoscope. 2018 Jan;128(1):78-83. doi: 10.1002/lary.26649. Epub 2017 Jul 6.
Maurice MJ, Kaouk JH. Single-Port Robot-Assisted Perineal Prostatectomy and Pelvic Lymphadenectomy: Step-by-Step Technique in a Cadaveric Model. J Endourol. 2018 May;32(S1):S93-S96. doi: 10.1089/end.2017.0707.
Chan JYK, Tsang RK, Holsinger FC, Tong MCF, Ng CWK, Chiu PWY, Ng SSM, Wong EWY. Prospective clinical trial to evaluate safety and feasibility of using a single port flexible robotic system for transoral head and neck surgery. Oral Oncol. 2019 Jul;94:101-105. doi: 10.1016/j.oraloncology.2019.05.018. Epub 2019 May 28.
Holsinger FC, Magnuson JS, Weinstein GS, Chan JYK, Starmer HM, Tsang RKY, Wong EWY, Rassekh CH, Bedi N, Hong SSY, Orosco R, O'Malley BW Jr, Moore EJ. A Next-Generation Single-Port Robotic Surgical System for Transoral Robotic Surgery: Results From Prospective Nonrandomized Clinical Trials. JAMA Otolaryngol Head Neck Surg. 2019 Nov 1;145(11):1027-1034. doi: 10.1001/jamaoto.2019.2654.
Berry RB, Brooks R, Gamaldo C, Harding SM, Lloyd RM, Quan SF, Troester MT, Vaughn BV. AASM Scoring Manual Updates for 2017 (Version 2.4). J Clin Sleep Med. 2017 May 15;13(5):665-666. doi: 10.5664/jcsm.6576. No abstract available.
Sundaram S, Bridgman SA, Lim J, Lasserson TJ. Surgery for obstructive sleep apnoea. Cochrane Database Syst Rev. 2005 Oct 19;(4):CD001004. doi: 10.1002/14651858.CD001004.pub2.
Semelka M, Wilson J, Floyd R. Diagnosis and Treatment of Obstructive Sleep Apnea in Adults. Am Fam Physician. 2016 Sep 1;94(5):355-60.
Hao W, Wang X, Fan J, Zeng Y, Ai H, Nie S, Wei Y. Association between apnea-hypopnea index and coronary artery calcification: a systematic review and meta-analysis. Ann Med. 2021 Dec;53(1):302-317. doi: 10.1080/07853890.2021.1875137.
Reutrakul S, Mokhlesi B. Obstructive Sleep Apnea and Diabetes: A State of the Art Review. Chest. 2017 Nov;152(5):1070-1086. doi: 10.1016/j.chest.2017.05.009. Epub 2017 May 17.
Punjabi NM. The epidemiology of adult obstructive sleep apnea. Proc Am Thorac Soc. 2008 Feb 15;5(2):136-43. doi: 10.1513/pats.200709-155MG.
Lee JJ, Sundar KM. Evaluation and Management of Adults with Obstructive Sleep Apnea Syndrome. Lung. 2021 Apr;199(2):87-101. doi: 10.1007/s00408-021-00426-w. Epub 2021 Mar 13.
Heinzer R, Vat S, Marques-Vidal P, Marti-Soler H, Andries D, Tobback N, Mooser V, Preisig M, Malhotra A, Waeber G, Vollenweider P, Tafti M, Haba-Rubio J. Prevalence of sleep-disordered breathing in the general population: the HypnoLaus study. Lancet Respir Med. 2015 Apr;3(4):310-8. doi: 10.1016/S2213-2600(15)00043-0. Epub 2015 Feb 12.
Epstein LJ, Kristo D, Strollo PJ Jr, Friedman N, Malhotra A, Patil SP, Ramar K, Rogers R, Schwab RJ, Weaver EM, Weinstein MD; Adult Obstructive Sleep Apnea Task Force of the American Academy of Sleep Medicine. Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults. J Clin Sleep Med. 2009 Jun 15;5(3):263-76.
Cirignotta F. Classification and definition of respiratory disorders during sleep. Minerva Med. 2004 Jun;95(3):177-85.
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/sleep/19.2.156.
Berg LM, Ankjell TKS, Sun YQ, Trovik TA, Rikardsen OG, Sjogren A, Moen K, Hellem S, Bugten V. Health-Related Quality of Life and Sleep Quality after 12 Months of Treatment in Nonsevere Obstructive Sleep Apnea: A Randomized Clinical Trial with Continuous Positive Airway Pressure and Mandibular Advancement Splints. Int J Otolaryngol. 2020 Jun 30;2020:2856460. doi: 10.1155/2020/2856460. eCollection 2020.
Sin DD, Mayers I, Man GC, Pawluk L. Long-term compliance rates to continuous positive airway pressure in obstructive sleep apnea: a population-based study. Chest. 2002 Feb;121(2):430-5. doi: 10.1378/chest.121.2.430.
Weaver TE, Grunstein RR. Adherence to continuous positive airway pressure therapy: the challenge to effective treatment. Proc Am Thorac Soc. 2008 Feb 15;5(2):173-8. doi: 10.1513/pats.200708-119MG.
Vicini C, Montevecchi F. Transoral Robotic Surgery for Obstructive Sleep Apnea: Past, Present, and Future. Sleep Med Clin. 2019 Mar;14(1):67-72. doi: 10.1016/j.jsmc.2018.10.008. Epub 2018 Nov 30.
Vicini C, Montevecchi F, Campanini A, Dallan I, Hoff PT, Spector ME, Thaler E, Ahn J, Baptista P, Remacle M, Lawson G, Benazzo M, Canzi P. Clinical outcomes and complications associated with TORS for OSAHS: a benchmark for evaluating an emerging surgical technology in a targeted application for benign disease. ORL J Otorhinolaryngol Relat Spec. 2014;76(2):63-9. doi: 10.1159/000360768. Epub 2014 Apr 23.
Lin HC, Friedman M, Chang HW, Gurpinar B. The efficacy of multilevel surgery of the upper airway in adults with obstructive sleep apnea/hypopnea syndrome. Laryngoscope. 2008 May;118(5):902-8. doi: 10.1097/MLG.0b013e31816422ea.
Lan WC, Chang WD, Tsai MH, Tsou YA. Trans-oral robotic surgery versus coblation tongue base reduction for obstructive sleep apnea syndrome. PeerJ. 2019 Oct 2;7:e7812. doi: 10.7717/peerj.7812. eCollection 2019.
Tsou YA, Hsu CC, Shih LC, Lin TC, Chiu CJ, Tien VH, Tsai MH, Chang WD. Combined Transoral Robotic Tongue Base Surgery and Palate Surgery in Obstructive Sleep Apnea Syndrome: Modified Uvulopalatopharyngoplasty versus Barbed Reposition Pharyngoplasty. J Clin Med. 2021 Jul 18;10(14):3169. doi: 10.3390/jcm10143169.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
113-01382A3
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.