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Change in Tongue Strength and Fatigue After Upper Airway Stimulation Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03980158
Recruitment Status : Completed
First Posted : June 10, 2019
Last Update Posted : June 10, 2019
Information provided by (Responsible Party):
Technische Universität München

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.

Condition or disease
Obstructive Sleep Apnea of Adult

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Study Type : Observational
Actual Enrollment : 103 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Change in Tongue Strength and Fatigue After Implantation of Upper Airway Stimulation System
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : November 16, 2018
Actual Study Completion Date : November 16, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

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

Primary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study population consists of three groups: the first group comprises of patients that have been implanted with selective hypoglossal nerve stimulation system (Inspire II Upper Airway Stimulation System, Inspire Medical Systems, Maple Grove, USA). The second group consists of confirmed OSA patients either being treated conservatively or without treatment. The test group consists of participants with no medical history for OSA and Epworth Sleepiness Scale (ESS) below 11.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03980158

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Department of Ear Nose Throat
Munich, Bavaria, Germany, 81675
Sponsors and Collaborators
Technische Universität München

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Technische Universität München Identifier: NCT03980158    
Other Study ID Numbers: 425/17S
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Signs and Symptoms