Surgical Treatment for Patients With Obstructive Sleep Apnea by Using Da Vinci SP Surgical System

Not Applicable

Not yet recruiting

• Conditions: Obstructive Sleep Apnea

• Registration Number: NCT06766760
• Lead Sponsor: Chang Gung Memorial Hospital

Brief 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. 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 Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-12-17
• Study Start: 2025-01-01
• Study First Submitted QC: 2025-01-08
• Last Update Submitted: 2025-01-08
• Study First Posted: 2025-01-09
• Last Update Posted: 2025-01-09
• Primary Completion: 2025-12-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Age 18 years or more.
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

1. BMI>35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Conversion rate	3 months (+60 days) post-surgery	Success of tongue base resection without conversion to alternative surgery
Apena Hypopnea Index	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.

Secondary Outcome Measures

Name	Time	Method
Multi-level surgery	Intraoperative	Multi-level surgery (procedure used)
Operative time	Intraoperative	Operative time (first skin incision to closure of wound)
Readmission rate	30 days	Readmission rate
Snoring Scale	3 months (+60 days) post-surgery	Snoring VAS
Console time	3 months (+60 days) post-surgery	Console time
Transfusion and estimated blood loss	3 months (+60 days) post-surgery	Transfusion and estimated blood loss
Length of hospital stay	3 months (+60 days) post-surgery	Length of hospital stay
Complication rate	30 days	Rate, intraoperative and/or postoperative, Clavien system
Reoperation rate	30 days	Reoperation rate
Perioperative mortality	30 days	Perioperative mortality
Volume of resected tissue	3 months (+60 days) post-surgery	measured using the volume displacement method
Pain score	3 months (+60 days) post-surgery	Pain score (VAS)
Sleepiness Scale	3 months (+60 days) post-surgery	Epworth Sleepiness Scale (ESS) and Stanford Sleepiness Scale (SSS) at 3 months (+60 days) post-surgery compared to baseline
Pittsburgh Sleep Quality Index (PSQI)	at 1, 3, 6 months post-surgery	Pittsburgh Sleep Quality Index (PSQI) at 1, 3, 6 months post-surgery compared to baseline.
Adverse Events	within 3 months (+60 days) post-surgery	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.

Trial Locations

Locations (1)

Linkou Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan