Treatment of Obstructive Sleep Apnea (OSA) With the da Vinci® SP™ Surgical System

An observational study of Obstructive Sleep Apnea, run by Intuitive Surgical at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

It is a prospective, single center, single-arm clinical study to enroll a maximum of 25 subjects. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Obstructive Sleep Apnea
What is being tested?: Transoral Robotic Surgery
Type of treatment: Medical device
How many people: 25 participants
Where: 1 siteSouth Korea
Study dates: 27 Jan 2021to 25 Jan 2023
Phase: Observational
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 to 80 years
All sexes
Adult, Older adult

Study population: * Subject who has failed or is unable to tolerate CPAP therapy * Subject who is diagnosed with OSA due to redundant base of tongue tissue * Subject who has moderate to severe sleep apnea, defined as 15 or more AHI events/hour * Subject who has planned a tongue base resection surgery

Who may be able to join

Subject is between 18 and 80 years old
Subject with BMI ≤ 35
Subject with moderate to severe sleep apnea, defined as 15 or more AHI events/hour
Subject who has failed or is unable to tolerate CPAP therapy
Subject diagnosed with OSA due to redundant base of tongue tissue
Subject must be a suitable candidate for base of tongue resection surgery
Subject who is willing and able to provide written informed consent
Subject who is willing and able to comply with the study protocol requirements

Who cannot join

Subject with a poor mouth opening or trismus
Subject with evidence of any primary cancers or metastatic disease, other than skin cancers
Subject who has had a surgical resection and/or chemoradiation therapy for oropharyngeal cancer
Subject with congenital malformations in the larynx, throat or tongue
Subject with an American Society of Anesthesiologists (ASA) score of Grade 4 or above during preoperative evaluation
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 who is mentally handicapped or with a psychological disorder or severe systemic illness, that would preclude compliance with study requirements or ability to provide informed consent
Subject is pregnant or suspected to be pregnant

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Severance Hospital, Yonsei University Health System
Seoul, 03722

Other trials in South Korea

About this study

Official title: A Prospective Single Center Investigation of the da Vinci® SP™ Surgical System for Transoral Robotic Surgery (TORS) for Treatment of Obstructive Sleep Apnea (OSA)

It is a prospective, single center, single-arm clinical study to enroll a maximum of 25 subjects.

Read the detailed description

It is a prospective, single center, single-arm clinical study to enroll a maximum of 25 subjects. The objective of this study is to evaluate the clinical utility of the da Vinci® SP™ Surgical System, instruments and accessories in TORS benign base of tongue resection procedures for the treatment of moderate to severe OSA. da Vinci® SP™ Surgical System, instruments and accessories are the approved medical device product by MFDS (Ministry of Food and Drug Safety, Republic of Korea).

Conditions: Obstructive Sleep Apnea
Being tested: Transoral Robotic Surgery
Keywords: OSA
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.

Transoral Robotic SurgeryDevice
Subjects will undergo TORS benign base of tongue resection procedures (i.e., partial glossectomy, epiglottoplasty, epiglottectomy, and/or lingual tonsillectomy) for the treatment of OSA. Concomitant non-robotic surgical procedures may also be performed as part of the subject's treatment for OSA, and can include one or more of the following: uvulopalatopharyngoplasty (UPPP), lateral pharyngoplasty, expansion sphincter pharyngoplasty, palatine tonsillectomy, or a modified uvulopalatoplasty. Nasal surgery such as septoplasty or turbinoplasty can be combined if it is needed.

Study groups in NCT04795817
Study group	Role	What they receive
Single arm		Subjects will undergo TORS benign base of tongue resection procedures (i.e., partial glossectomy, epiglottoplasty, epiglottectomy, and/or lingual tonsillectomy) for the treatment of OSA Receives: Device: Transoral Robotic Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

Type 1 Polysomnography (PSG)
Type I PSG measurements demonstrating Apnea Hypopnea Index (AHI) reduction.
Measured: Pre-operative (within 12 months prior to surgery)
Type 1 Polysomnography (PSG)
Type I PSG measurements demonstrating Apnea Hypopnea Index (AHI) reduction.
Measured: 90-150 days after surgery

Secondary outcomes (19)

Total operative time
defined as the time the patient spends in the operating room (OR), i.e. OR "In and Out" time. This includes the patient prep time, anesthesia time, robotic docking time, robotic procedure time and time taken for non-robotic concomitant procedures, which are part of the multi-level surgical treatment approach for that particular patient.
Measured: Intra-Operative Assessment
Robotic procedure time
defined as time from docking the robot at the initiation of surgery to undocking at the completion of surgery.
Measured: Intra-Operative Assessment
Estimated blood loss (EBL)
defined as the estimated amount of blood loss
Measured: Intra-Operative Assessment
Postoperative hemorrhage
categorized using the Common Terminology Criteria for Adverse Events (CTCAE) v4.03
Measured: Intra-Operative Assessment
Blood transfusions
defined as whether a blood transfusion was applied or not.
Measured: Intra-Operative Assessment
Length of hospital stay (LOS)
Duration of hospital say(from admission to discharge)
Measured: Admission to the hospital to discharge from the hospital (check out time), up to an approximate of one week
Volume of resected tissue
measured using the volume displacement method
Measured: Immediately after surgery
Conversion rate
from da Vinci SP surgery to any alternate method required to complete the indicated procedure.
Measured: Intra-Operative Assessment
Change in Apnea index (AI)
at 3 months (+60 days) post-surgery compared to baseline
Measured: Pre-operative Assessments & Post-Operative (3 months +60 days) Assessment
Change in Hypopnea index (HI)
at 3 months (+60 days) post-surgery compared to baseline
Measured: Pre-operative Assessments & Post-Operative (3 months +60 days) Assessment
Change in Percentages of sleep stages (N1, N2, N3, R)
at 3 months (+60 days) post-surgery compared to baseline
Measured: Pre-operative Assessments & Post-Operative (3 months +60 days) Assessment
Change in Lowest oxygen saturation (LSAT)
at 3 months (+60 days) post-surgery compared to baseline
Measured: Pre-operative Assessments & Post-Operative (3 months +60 days) Assessment
Change in Percent sleep time below 90 percent oxygen saturation (ST90)
at 3 months (+60 days) post-surgery compared to baseline
Measured: Pre-operative Assessments & Post-Operative (3 months +60 days) Assessment
Change in Epworth Sleepiness Scale (ESS)
at 3 months (+60 days) post-surgery compared to baseline
Measured: Pre-operative Assessments & Post-Operative (3 months +60 days) Assessment
Change in Stanford Sleepiness Scale (SSS)
at 3 months (+60 days) post-surgery compared to baseline
Measured: Pre-operative Assessments & Post-Operative (3 months, +60 days) Assessment
Change in Berlin Questionnaire
at 3 months (+60days) compared to baseline
Measured: Pre-operative Assessments & Post-Operative (3 months, +60 days) Assessment
Change in MDADI (MD Anderson Dysphagia Inventory)
at 3 months (+60days) compared to baseline
Measured: Pre-operative Assessments & Post-Operative (3 months, +60 days) Assessment
Adverse Events (AE)
Assessment of all reported adverse events (AE) within 3 months +60 days (90-150 days) post-surgery. Summarizing the incidence and frequency of all reported adverse events and categorizing them using CTCAE v4.03
Measured: Through study conclusion (3 month follow up +60 days)
Change in Upper airway volume
measured by CT scan as optional
Measured: Pre-operative Assessment, Post-operative (within 30days ±14 days from surgery) Assessment & Post-Operative (3 months, +60 days) Assessment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Jan 202125 Jan 2023

First posted12 Mar 2021
Study start27 Jan 2021
Primary completion25 Jan 2023
Study completion25 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)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 Intuitive SurgicalThe 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04795817
Sponsor's protocol ID: dV SP-TORS OSA
Status last verified: May 2023
First submitted: 1 Feb 2021
Last updated: 31 May 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Jeong Y, Rha MS, Kim CH, Cho HJ. First Prospective Study on Single-Port Robotic Tongue Base Resection for Sleep Apnea. Head Neck. 2025 Apr;47(4):1071-1078. doi: 10.1002/hed.28007. Epub 2024 Nov 22.
PubMed 39576059

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea

All Obstructive Sleep Apnea trials

Study at a glance

From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Single Center Investigation of the da Vinci® SP™ Surgical System for Transoral Robotic Surgery (TORS) for Treatment of Obstructive Sleep Apnea (OSA)
ClinicalTrials.gov ID: NCT04795817
Acronym / sponsor ID: dV SP-TORS OSA
Conditions: Obstructive Sleep Apnea
Keywords: OSA
Study type: Observational
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Intuitive SurgicalIndustry (pharma, biotech, devices)
Study start: 27 Jan 2021 (actual)
Primary completion: 25 Jan 2023 (actual)
Study completion: 25 Jan 2023 (actual)
First posted: 12 Mar 2021 (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.

It is a prospective, single center, single-arm clinical study to enroll a maximum of 25 subjects.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Single arm	–	Device: Transoral Robotic SurgerySubjects will undergo TORS benign base of tongue resection procedures (i.e., partial glossectomy, epiglottoplasty, epiglottectomy, and/or lingual tonsillectomy) for the treatment of OSA

Who may qualify

Ages: 18 to 80 years
Sex: All
Age groups: Adult, Older adult
Study population: * Subject who has failed or is unable to tolerate CPAP therapy * Subject who is diagnosed with OSA due to redundant base of tongue tissue * Subject who has moderate to severe sleep apnea, defined as 15 or more AHI events/hour * Subject who has planned a tongue base resection surgery

Key inclusion criteria (8 listed)

Subject is between 18 and 80 years old
Subject with BMI ≤ 35
Subject with moderate to severe sleep apnea, defined as 15 or more AHI events/hour
Subject who has failed or is unable to tolerate CPAP therapy
Subject diagnosed with OSA due to redundant base of tongue tissue

Key exclusion criteria (8 listed)

Subject with a poor mouth opening or trismus
Subject with evidence of any primary cancers or metastatic disease, other than skin cancers
Subject who has had a surgical resection and/or chemoradiation therapy for oropharyngeal cancer
Subject with congenital malformations in the larynx, throat or tongue
Subject with an American Society of Anesthesiologists (ASA) score of Grade 4 or above during preoperative evaluation

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
Transoral Robotic SurgerySubjects will undergo TORS benign base of tongue resection procedures (i.e., partial glossectomy, epiglottoplasty, epiglottectomy, and/or lingual tonsillectomy) for the treatment of OSA. Concomitant non-robotic surgical procedures may also be performed as part of the subject's treatment for OSA, and can include one or more of the following: uvulopalatopharyngoplasty (UPPP), lateral pharyngoplasty, expansion sphincter pharyngoplasty, palatine tonsillectomy, or a modified uvulopalatoplasty. Nasal surgery such as septoplasty or turbinoplasty can be combined if it is needed.	Device	Single arm

Primary outcome

Type 1 Polysomnography (PSG)
Time frame: Pre-operative (within 12 months prior to surgery)
Type I PSG measurements demonstrating Apnea Hypopnea Index (AHI) reduction.
Type 1 Polysomnography (PSG)
Time frame: 90-150 days after surgery
Type I PSG measurements demonstrating Apnea Hypopnea Index (AHI) reduction.

19 secondary outcomes

Total operative time
Time frame: Intra-Operative Assessment
Robotic procedure time
Time frame: Intra-Operative Assessment
Estimated blood loss (EBL)
Time frame: Intra-Operative Assessment
Postoperative hemorrhage
Time frame: Intra-Operative Assessment
Blood transfusions
Time frame: Intra-Operative Assessment
Length of hospital stay (LOS)
Time frame: Admission to the hospital to discharge from the hospital (check out time), up to an approximate of one week
Volume of resected tissue
Time frame: Immediately after surgery
Conversion rate
Time frame: Intra-Operative Assessment
Change in Apnea index (AI)
Time frame: Pre-operative Assessments & Post-Operative (3 months +60 days) Assessment
Change in Hypopnea index (HI)
Time frame: Pre-operative Assessments & Post-Operative (3 months +60 days) Assessment
Change in Percentages of sleep stages (N1, N2, N3, R)
Time frame: Pre-operative Assessments & Post-Operative (3 months +60 days) Assessment
Change in Lowest oxygen saturation (LSAT)
Time frame: Pre-operative Assessments & Post-Operative (3 months +60 days) Assessment
Change in Percent sleep time below 90 percent oxygen saturation (ST90)
Time frame: Pre-operative Assessments & Post-Operative (3 months +60 days) Assessment
Change in Epworth Sleepiness Scale (ESS)
Time frame: Pre-operative Assessments & Post-Operative (3 months +60 days) Assessment
Change in Stanford Sleepiness Scale (SSS)
Time frame: Pre-operative Assessments & Post-Operative (3 months, +60 days) Assessment
Change in Berlin Questionnaire
Time frame: Pre-operative Assessments & Post-Operative (3 months, +60 days) Assessment
Change in MDADI (MD Anderson Dysphagia Inventory)
Time frame: Pre-operative Assessments & Post-Operative (3 months, +60 days) Assessment
Adverse Events (AE)
Time frame: Through study conclusion (3 month follow up +60 days)
Change in Upper airway volume
Time frame: Pre-operative Assessment, Post-operative (within 30days ±14 days from surgery) Assessment & Post-Operative (3 months, +60 days) Assessment

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
Derived from this study: PubMed 39576059Jeong Y, Rha MS, Kim CH, Cho HJ. First Prospective Study on Single-Port Robotic Tongue Base Resection for Sleep Apnea. Head Neck. 2025 Apr;47(4):1071-1078. doi: 10.1002/hed.28007. Epub 2024 Nov 22.
Individual participant dataSharing planned: Undecided

Related trials for Obstructive Sleep Apnea

RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea

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.

HyungJu Cho, M.D., Ph.D. principal investigator

Severance Hospital, Yonsei University Health System

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Obstructive Sleep Apnea, run by Intuitive Surgical at 1 site in South Korea.

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 8 inclusion and 8 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: finished, as of the sponsor's last update on 31 May 2023. 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 South Korea. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Type 1 Polysomnography (PSG) (time frame: Pre-operative (within 12 months prior to 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 NCT04795817, which also lists 1 linked publication.

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 31 May 2023.