Change in Tongue Strength and Fatigue After Upper Airway Stimulation Therapy

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03980158

Enrollment

103

Registered

2019-06-10

Start date

2018-03-01

Completion date

2018-11-16

Last updated

2019-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea of Adult

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Countries

Germany

Outcome results