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Change in Tongue Strength and Fatigue After Upper Airway Stimulation Therapy

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ClinicalTrials.gov Identifier: NCT03980158
Recruitment Status : Completed
First Posted : June 10, 2019
Last Update Posted : June 10, 2019
Sponsor:
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

Group/Cohort
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.
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03980158


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

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Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT03980158     History of Changes
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
Fatigue
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Signs and Symptoms