Change in Tongue Strength and Fatigue After Upper Airway Stimulation Therapy

Completed

• Conditions: Obstructive Sleep Apnea of Adult

• Registration Number: NCT03980158
• Lead Sponsor: Technical University of Munich

Brief Summary

Upper airway stimulation (UAS) is an effective surgical alternative for patients with obstructive sleep apnea (OSA) who fail continuous positive airway pressure (CPAP) therapy. This stimulation could lead to alterations in tongue strength and fatigability which could alter treatment outcome. The aim of the study is to investigate if UAS alters tongue strength and fatigability.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-01
• Primary Completion: 2018-11-16
• Study Completion: 2018-11-16
• Study First Submitted: 2019-05-26
• Status Verified: 2019-06
• Study First Submitted QC: 2019-06-06
• Last Update Submitted: 2019-06-06
• Study First Posted: 2019-06-10
• Last Update Posted: 2019-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

• 18 years old or older
• upper airway stimulation group: Upper airway stimulation system implanted at least 4 weeks ago
• OSA group: OSA confirmed by 18-channel inpatient overnight polysomnography (PSG)
• test group: No medical history for OSA and Epworth Sleepiness Scale (ESS) below 11

Exclusion Criteria

• history of a neuromuscular disorder
• previous tongue surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tongue protrusion strength	Up to 60 months after implanation	Tongue protrusion strength (peak pressure in kPa)
Tongue fatigability	Up to 60 months after implanation	Time to task failure during 50% of peak pressure contraction in seconds

Trial Locations

Locations (1)

Department of Ear Nose Throat; 🇩🇪 Munich, Bavaria, Germany