Change in Tongue Strength and Fatigue After Upper Airway Stimulation Therapy

NCT03980158 | Completed

• 1 other identifier: 425/17S
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea of Adult

Outcome Measures

Primary Outcomes (2)

• Tongue protrusion strength

  Tongue protrusion strength (peak pressure in kPa)

  Up to 60 months after implanation

• Tongue fatigability

  Time to task failure during 50% of peak pressure contraction in seconds

  Up to 60 months after implanation

Study Arms (3)

Upper airway stimulation group

OSA group with conservative / no treatment

Test group without OSA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• history of a neuromuscular disorder
• previous tongue surgery

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Department of Ear Nose Throat

Munich, Bavaria, 81675, Germany

Location

Related Publications (1)

• Wirth M, Unterhuber D, von Meyer F, Hofauer B, Ott A, Edenharter G, Eckert DJ, Heiser C. Hypoglossal nerve stimulation therapy does not alter tongue protrusion strength and fatigability in obstructive sleep apnea. J Clin Sleep Med. 2020 Feb 15;16(2):285-292. doi: 10.5664/jcsm.8184. Epub 2020 Jan 13.

  PMID: 31992396 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2019
• First Posted: June 10, 2019
• Study Start: March 1, 2018
• Primary Completion: November 16, 2018
• Study Completion: November 16, 2018
• Last Updated: June 10, 2019

Record last verified: 2019-06

Locations

DE (1)