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.

Recruiting

• Conditions: obstructieve slaap apneu; obstructive sleep apnea; sleep disorder; 10019190

• Registration Number: NL-OMON56291
• Lead Sponsor: Medisch Centrum Leeuwarden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 50

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

- 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure is a PSG measurement, the apnea-hypopnea index<br /><br>(AHI) at 6 months.</p><br>