Obstructive Sleep Apnea of AdultNCT03980158
Change in Tongue Strength and Fatigue After Upper Airway Stimulation Therapy
An observational study of Obstructive Sleep Apnea of Adult, run by Technical University of Munich at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea of Adult
- How many people
- 103 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2018to 16 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- history of a neuromuscular disorder
- previous tongue surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Change in Tongue Strength and Fatigue After Implantation of Upper Airway Stimulation System
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Upper airway stimulation group | Not described | |
| OSA group with conservative / no treatment | Not described | |
| Test group without OSA | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tongue protrusion strength
Tongue protrusion strength (peak pressure in kPa)
Measured: Up to 60 months after implanation
Tongue fatigability
Time to task failure during 50% of peak pressure contraction in seconds
Measured: Up to 60 months after implanation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start1 Mar 2018
- Primary completion16 Nov 2018
- Study completion16 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea of AdultStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03980158
- Sponsor's protocol ID
- 425/17S
- Status last verified
- Jun 2019
- First submitted
- 26 May 2019
- Last updated
- 10 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31992396
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change in Tongue Strength and Fatigue After Implantation of Upper Airway Stimulation System
- ClinicalTrials.gov ID
- NCT03980158
- Acronym / sponsor ID
- 425/17S
- Conditions
- Obstructive Sleep Apnea of Adult
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 16 Nov 2018 (actual)
- Study completion
- 16 Nov 2018 (actual)
- First posted
- 10 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Upper airway stimulation group | – | – |
| OSA group with conservative / no treatment | – | – |
| Test group without OSA | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- history of a neuromuscular disorder
- previous tongue surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2019.
- Derived from this study: PubMed 31992396Wirth 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea of Adult, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tongue protrusion strength (time frame: Up to 60 months after implanation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03980158, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2019.