NCT03980158CompletedNot Applicable
Change in Tongue Strength and Fatigue After Implantation of Upper Airway Stimulation System
Technical University of Munich1 site in 1 country103 target enrollmentStarted: March 1, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 103
- Locations
- 1
- Primary Endpoint
- Tongue protrusion strength
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Effect of Upper Airway Stimulation in Patients With Obstructive Sleep ApneaObstructive Sleep ApneaNCT03760328Technical University of Munich100
Completed
Not Applicable
Tongue Advancement for Obstructive Sleep ApneaSleep Apnea, ObstructiveNCT00490984Aspire Medical60
Completed
Not Applicable
Tongue Morphology and Posterior Airway Space as Predictors of Response in Patientswith Hypoglossal Nerve Stimulation TherapyObstructive Sleep ApneaSleep-Disordered BreathingNCT06154577Cantonal Hosptal, Baselland65
Unknown
Not Applicable
Clinical Study of Customized Adjustable Oral in Treatment of Patients With Obstructive Sleep Apnea SyndromeObstructive Sleep Apnea SyndromeNCT03729895Affiliated Hospital to Academy of Military Medical Sciences24
Unknown
Phase 1
Upper Airway Toning for Improve the Compliance of CPAPSleep Apnea, ObstructiveNCT01936038Fisiolistic110