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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

Tracking Information
First Submitted Date May 26, 2019
First Posted Date June 10, 2019
Last Update Posted Date June 10, 2019
Actual Study Start Date March 1, 2018
Actual Primary Completion Date November 16, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 6, 2019)
  • 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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Change in Tongue Strength and Fatigue After Upper Airway Stimulation Therapy
Official Title Change in Tongue Strength and Fatigue After Implantation of Upper Airway Stimulation System
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Obstructive Sleep Apnea of Adult
Intervention Not Provided
Study Groups/Cohorts
  • Upper airway stimulation group
  • OSA group with conservative / no treatment
  • Test group without OSA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 6, 2019)
103
Original Actual Enrollment Same as current
Actual Study Completion Date November 16, 2018
Actual Primary Completion Date November 16, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT03980158
Other Study ID Numbers 425/17S
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Technische Universität München
Study Sponsor Technische Universität München
Collaborators Not Provided
Investigators Not Provided
PRS Account Technische Universität München
Verification Date June 2019