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Completed

NCT Number: NCT03980158

Change in Tongue Strength and Fatigue After Upper Airway Stimulation Therapy

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.

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Key information

Conditions

Obstructive Sleep Apnea of Adult

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Ear Nose Throat

Munich, Bavaria, 81675, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Tongue protrusion strength

    Time frame: Up to 60 months after implanation

    Tongue protrusion strength (peak pressure in kPa)

  2. Tongue fatigability

    Time frame: Up to 60 months after implanation

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

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 10, 2019
Registry last updated
Jun 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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