Change in Tongue Strength and Fatigue After Upper Airway Stimulation Therapy

Technical University of Munich103 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

103

Conditions

Obstructive Sleep Apnea of Adult

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Department of Ear Nose Throat

Munich, Bavaria, Germany

Outcomes

Primary Outcomes

Tongue protrusion strength

Tongue protrusion strength (peak pressure in kPa)

Time frame: Up to 60 months after implanation

Tongue fatigability

Time to task failure during 50% of peak pressure contraction in seconds

Time frame: Up to 60 months after implanation

Data from ClinicalTrials.gov

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