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Change in Tongue Strength and Fatigue After Upper Airway Stimulation Therapy

T

Technical University of Munich

Status

Completed

Conditions

Obstructive Sleep Apnea of Adult

Study type

Observational

Funder types

Other

Identifiers

NCT03980158
425/17S

Details and patient eligibility

About

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.

Enrollment

103 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

103 participants in 3 patient groups

Upper airway stimulation group
OSA group with conservative / no treatment
Test group without OSA

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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