Transoral robot surgery of the tongue base vs. Continuous positive airway pressure or mandibular advancement device as a treatment for moderate to severe obstructive sleep apnea.

Transoral robot surgery of the tongue base vs. Continuous positive airway pressure or mandibular advancement device as a treatment for moderate to severe obstructive sleep apnea. - RAPID

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON56291

Enrollment

Registered

2023-09-27

Start date

2024-07-24

Completion date

Unknown

Last updated

2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

obstructieve slaap apneu obstructive sleep apnea sleep disorder

Interventions

Group 1 will contain 25 patients that will receive TORS as treatment of OSA. Group 2 will contain 25 patients that will receive standard treatment via CPAP or MAD depending on what patient and physi

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Participant has to be 18 years or older. - Participant should understand study protocol. - Apnea hypopnea index (AHI) during polysomnography (PSG) equal to 15 or higher. - During physical examination tongue tonsil of Friedman grade 3 or 4. - During sleep endoscopy collaps of tongue base level grade 2.

Exclusion criteria

Exclusion criteria: - BMI of 32 or higher. - During sleep endoscopy concentric collaps. - Symptoms of central sleep apnea syndrome (CSAS). - Participants with ASA score of 4. - Excessive use of opiates and benzodiazepines. - History of treatment with CPAP or not tolerating of MAD.

Design outcomes

Primary

Measure	Time frame
The primary outcome measure is a PSG measurement, the apnea-hypopnea index (AHI) at 6 months.	—

Secondary

Measure	Time frame
Secundary study parameters: • To establish whether TORS long term outcomes of 12 months are superior to CPAP and MAD in terms of AHI. • To compare other outcomes of the PSG such as ODI 4% at 6 and 12 months in TORS and CPAP/MAD patients. • To compare functional outcome of sleep after TORS to CPAP and MAD through ESS questionnaire at 12 months. • To evaluate surgical complications after TORS. • To evaluate health related quality of life in TORS group versus CPAP/MAD group via FOSQ, EQ-5D-5L and GBI questionnaires. • To assess costs of TORS and CPAP and MAD treatment. • To assess CPAP and MAD compliance via read out of CPAP and consultations via pulmonologist and maxilla facial oral surgeon. • To systematically measure and analyse relevant surgical parameters such as operative time, length of hospital stay and to evaluate the effectiveness and efficiency of TORS and thereby optimizing surgical practices. • To assess post-operative pain levels after TORS via VAS pain scores at baseline, after surgery, day 1, day 3 or 4 and the day of discharge. • To assess swallowing quality after TORS via VAS scores for swallowing, swallowing questionnaires at baseline, 3, 6 and 12 months and via assessment by language speech pathologist at baseline, 2 days post-surgery and 6 weeks. • To determine differences in VAS scores for snoring, tiredness and globus at baseline, 3, 6 and 12 months between TORS group and CPAP/MAD group. • To establish baseline descriptive characteristics and variables of the study population in terms of findings during ENT examination, BMI, history of smoking and reflux.	—

Measure

Time frame

Secundary study parameters: • To establish whether TORS long term outcomes of 12 months are superior to CPAP and MAD in terms of AHI. • To compare other outcomes of the PSG such as ODI 4% at 6 and 12 months in TORS and CPAP/MAD patients. • To compare functional outcome of sleep after TORS to CPAP and MAD through ESS questionnaire at 12 months. • To evaluate surgical complications after TORS. • To evaluate health related quality of life in TORS group versus CPAP/MAD group via FOSQ, EQ-5D-5L and GBI questionnaires. • To assess costs of TORS and CPAP and MAD treatment. • To assess CPAP and MAD compliance via read out of CPAP and consultations via pulmonologist and maxilla facial oral surgeon. • To systematically measure and analyse relevant surgical parameters such as operative time, length of hospital stay and to evaluate the effectiveness and efficiency of TORS and thereby optimizing surgical practices. • To assess post-operative pain levels after TORS via VAS pain scores at baseline, after surgery, day 1, day 3 or 4 and the day of discharge. • To assess swallowing quality after TORS via VAS scores for swallowing, swallowing questionnaires at baseline, 3, 6 and 12 months and via assessment by language speech pathologist at baseline, 2 days post-surgery and 6 weeks. • To determine differences in VAS scores for snoring, tiredness and globus at baseline, 3, 6 and 12 months between TORS group and CPAP/MAD group. • To establish baseline descriptive characteristics and variables of the study population in terms of findings during ENT examination, BMI, history of smoking and reflux.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 11, 2026