Change in Tongue Strength and Fatigue After Upper Airway Stimulation Therapy

Obstructive Sleep Apnea of Adult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03980158
• Other study ID #: 425/17S
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: November 16, 2018

Study information

• Verified date: June 2019
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: November 16, 2018
• Est. primary completion date: November 16, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Obstructive Sleep Apnea of Adult
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Germany	Department of Ear Nose Throat	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tongue protrusion strength	Tongue protrusion strength (peak pressure in kPa)	Up to 60 months after implanation
Primary	Tongue fatigability	Time to task failure during 50% of peak pressure contraction in seconds	Up to 60 months after implanation