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Clinical Trials/NCT03980158
NCT03980158CompletedNot Applicable

Change in Tongue Strength and Fatigue After Implantation of Upper Airway Stimulation System

Technical University of Munich1 site in 1 country103 target enrollmentStarted: March 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
103
Locations
1
Primary Endpoint
Tongue protrusion strength

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Tongue protrusion strength

Time Frame: Up to 60 months after implanation

Tongue protrusion strength (peak pressure in kPa)

Tongue fatigability

Time Frame: Up to 60 months after implanation

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Technical University of Munich
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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