Obstructive Sleep ApneaNCT06766760
Surgical Treatment for Patients With Obstructive Sleep Apnea by Using Da Vinci SP Surgical System
A study testing Da Vinci SP Surgical System, Model SP1098 in people with Obstructive Sleep Apnea, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This prospective, interventional, non-randomized, single arm, clinical trial will investigate feasibility and safety of trans-oral robotic surgery using da Vinci SP Surgical System in Taiwan for the surgical treatment of OSA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Da Vinci SP Surgical System, Model SP1098
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or more.
- OSA with AHI ≥ 15
- Has failed, refuses, or is unable to tolerate CPAP therapy
- 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)
- ASA physical status classification 1-2 and adequate organ function
- Patients willing and able to comply with study protocol requirements and follow-up
- Informed consent
Who cannot join
- BMI>35
- Mouth opening too narrow for TORS or trismus
- Betel nut chewing
- Suspicious cancer diagnosis
- Prior head-and-neck surgery (note: prior invasive therapy for OSA allowed)
- 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
Show all 16Show fewer
- Active infectious disease
- Can't follow trial-required procedures
- 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)
- Long-term use of anti-coagulant
- Patients with coagulopathy
- Emergency surgery
- 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
- Subject is pregnant or suspected to be pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Single-port Robot-assisted Surgery Using da Vinci SP Surgical System for the Surgical Treatment for Patients With Obstructive Sleep Apnea
This prospective, interventional, non-randomized, single arm, clinical trial will investigate feasibility and safety of trans-oral robotic surgery using da Vinci SP Surgical System in Taiwan for the surgical treatment of OSA. All the investigators are well trained and have received proof of training after completing the training program for da Vinci SP system provided by Intuitive.
Read the detailed description
This study will be conducted in Chang Gung Memorial Hospital at Linkou.
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
- Obstructive Sleep Apnea
- Being tested
- Da Vinci SP Surgical System, Model SP1098
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Da Vinci SP Surgical System, Model SP1098Device
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.
| Study group | Role | What they receive |
|---|---|---|
| OSAS with SP Da Vinci | Experimental | Not described Receives: Device: Da Vinci SP Surgical System, Model SP1098 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion rate
Success of tongue base resection without conversion to alternative surgery
Measured: 3 months (+60 days) post-surgery
Apena Hypopnea Index
Type I PSG measurements demonstrating Apena Hypopnea Index (AHI) reduction. An AHI of < 20 events/hour and a reduction in AHI of 50% or greater from baseline levels will be defined as success, when evaluated at 3 months (+60 days) post-surgery. Although it does not meet these criteria, it can be interpreted as an "improved" result when AHI is improved after surgery.
Measured: 3 months (+60 days) post-surgery
Secondary outcomes (15)
Multi-level surgery
Multi-level surgery (procedure used)
Measured: Intraoperative
Snoring Scale
Snoring VAS
Measured: 3 months (+60 days) post-surgery
Operative time
Operative time (first skin incision to closure of wound)
Measured: Intraoperative
Console time
Console time
Measured: 3 months (+60 days) post-surgery
Transfusion and estimated blood loss
Transfusion and estimated blood loss
Measured: 3 months (+60 days) post-surgery
Length of hospital stay
Length of hospital stay
Measured: 3 months (+60 days) post-surgery
Complication rate
Rate, intraoperative and/or postoperative, Clavien system
Measured: 30 days
Readmission rate
Readmission rate
Measured: 30 days
Reoperation rate
Reoperation rate
Measured: 30 days
Perioperative mortality
Perioperative mortality
Measured: 30 days
Volume of resected tissue
measured using the volume displacement method
Measured: 3 months (+60 days) post-surgery
Pain score
Pain score (VAS)
Measured: 3 months (+60 days) post-surgery
Sleepiness Scale
Epworth Sleepiness Scale (ESS) and Stanford Sleepiness Scale (SSS) at 3 months (+60 days) post-surgery compared to baseline
Measured: 3 months (+60 days) post-surgery
Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index (PSQI) at 1, 3, 6 months post-surgery compared to baseline.
Measured: at 1, 3, 6 months post-surgery
Adverse Events
Assessment of all reported adverse events (AE) within 3 months, (+60 days) post-surgery. Summarizing the incidence and frequency of all reported adverse events and categorizing them using CTCAE.
Measured: within 3 months (+60 days) post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start1 Jan 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766760
- Sponsor's protocol ID
- 113-01382A3
- Status last verified
- Aug 2024
- First submitted
- 17 Dec 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 37972462Baptista 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.
PubMed 35207264Lin 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.
PubMed 32917413Park 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.
PubMed 31502020Holsinger 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.
PubMed 26509920Chen 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.
PubMed 28681924Maurice 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.
PubMed 29774808Chan 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.
PubMed 31178203Holsinger 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.
PubMed 31536129Berry 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.
PubMed 28416048Sundaram S, Bridgman SA, Lim J, Lasserson TJ. Surgery for obstructive sleep apnoea. Cochrane Database Syst Rev. 2005 Oct 19;2005(4):CD001004. doi: 10.1002/14651858.CD001004.pub2.
PubMed 16235277Semelka M, Wilson J, Floyd R. Diagnosis and Treatment of Obstructive Sleep Apnea in Adults. Am Fam Physician. 2016 Sep 1;94(5):355-60.
PubMed 27583421Hao 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.
PubMed 33522282Reutrakul 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.
PubMed 28527878Punjabi 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.
PubMed 18250205
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Single-port Robot-assisted Surgery Using da Vinci SP Surgical System for the Surgical Treatment for Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT06766760
- Acronym / sponsor ID
- 113-01382A3
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective, interventional, non-randomized, single arm, clinical trial will investigate feasibility and safety of trans-oral robotic surgery using da Vinci SP Surgical System in Taiwan for the surgical treatment of OSA. All the investigators are well trained and have received proof of training after completing the training program for da Vinci SP system provided by Intuitive.
Detailed description
This study will be conducted in Chang Gung Memorial Hospital at Linkou.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OSAS with SP Da Vinci | Experimental | Device: Da Vinci SP Surgical System, Model SP1098 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years or more.
- OSA with AHI ≥ 15
- Has failed, refuses, or is unable to tolerate CPAP therapy
- 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)
- ASA physical status classification 1-2 and adequate organ function
Key exclusion criteria (16 listed)
- BMI>35
- Mouth opening too narrow for TORS or trismus
- Betel nut chewing
- Suspicious cancer diagnosis
- Prior head-and-neck surgery (note: prior invasive therapy for OSA allowed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Da Vinci SP Surgical System, Model SP1098The 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. | Device | OSAS with SP Da Vinci |
Primary outcome
Conversion rate
Time frame: 3 months (+60 days) post-surgery
Success of tongue base resection without conversion to alternative surgery
Apena Hypopnea Index
Time frame: 3 months (+60 days) post-surgery
Type I PSG measurements demonstrating Apena Hypopnea Index (AHI) reduction. An AHI of < 20 events/hour and a reduction in AHI of 50% or greater from baseline levels will be defined as success, when evaluated at 3 months (+60 days) post-surgery. Although it does not meet these criteria, it can be interpreted as an "improved" result when AHI is improved after surgery.
15 secondary outcomes
Multi-level surgery
Time frame: Intraoperative
Snoring Scale
Time frame: 3 months (+60 days) post-surgery
Operative time
Time frame: Intraoperative
Console time
Time frame: 3 months (+60 days) post-surgery
Transfusion and estimated blood loss
Time frame: 3 months (+60 days) post-surgery
Length of hospital stay
Time frame: 3 months (+60 days) post-surgery
Complication rate
Time frame: 30 days
Readmission rate
Time frame: 30 days
Reoperation rate
Time frame: 30 days
Perioperative mortality
Time frame: 30 days
Volume of resected tissue
Time frame: 3 months (+60 days) post-surgery
Pain score
Time frame: 3 months (+60 days) post-surgery
Sleepiness Scale
Time frame: 3 months (+60 days) post-surgery
Pittsburgh Sleep Quality Index (PSQI)
Time frame: at 1, 3, 6 months post-surgery
Adverse Events
Time frame: within 3 months (+60 days) post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Results publication: PubMed 37972462Costantino 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.
- Results publication: PubMed 35207264Baptista 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.
- Results publication: PubMed 32917413Lin 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.
- Results publication: PubMed 31502020Park 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.
- Results publication: PubMed 26509920Holsinger 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.
- Results publication: PubMed 28681924Chen 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.
- Results publication: PubMed 29774808Maurice 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.
- Results publication: PubMed 31178203Chan 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.
- Results publication: PubMed 31536129Holsinger 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.
- Results publication: PubMed 28416048Berry 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.
- Results publication: PubMed 16235277Sundaram S, Bridgman SA, Lim J, Lasserson TJ. Surgery for obstructive sleep apnoea. Cochrane Database Syst Rev. 2005 Oct 19;2005(4):CD001004. doi: 10.1002/14651858.CD001004.pub2.
- Results publication: PubMed 27583421Semelka M, Wilson J, Floyd R. Diagnosis and Treatment of Obstructive Sleep Apnea in Adults. Am Fam Physician. 2016 Sep 1;94(5):355-60.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Da Vinci SP Surgical System, Model SP1098 in people with Obstructive Sleep Apnea, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tuan-Jen Fang (+886-3-32801200 ext. 3971, fang3109@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conversion rate (time frame: 3 months (+60 days) post-surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06766760, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.