Obstructive Sleep Apnea SyndromeNCT03846349
Reinforcement of Upper Airway Muscles in Patients With OSAS
A study testing IOPI and EMT threshold in people with Obstructive Sleep Apnea Syndrome, run by Haute Ecole de Santé Vaud at 2 sites in Switzerland.
Trial summary
This study will investigate the effectiveness of a simple and quick myofunctional reeducation protocol of the tongue in reducing the obstructive sleep apnea syndrome (OSAS) severity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- What is being tested?
- IOPI and EMT threshold
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Aug 2019to 1 Jul 2020
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate obstructive sleep apnea syndrome (AHI between 15 and 30 events per hour)
- Poor adherence to continuous positive airway pressure (< 4h per night)
Who cannot join
- Craniofacial malformation
- Use of hypnotic medication
- Had stroke in the past
- Present a concurrent neuromuscular or severe obstructive nasal disease
Trial locations and contacts
2 sites in 1 country.
William Poncin, PhD contact
Switzerland2 sites, 2 recruiting
- Not yet recruiting
Ligue Pulmonaire Genevoise
Geneva, 1205
Olivier Contal, PhD, +41213168122, olivier.contal@hesav.ch
- Recruiting
Haute Ecole de Santé Vaud (HESAV)
Lausanne, 1011
Olivier Contal, PhD, +41213168122, olivier.contal@uclouvain.be
William Poncin, PhD
About this study
Official title: Non-invasive Reinforcement of the Upper Airway Dilator Muscles as an Alternative Approach to Treat Patients With Obstructive Sleep Apnea
This study will investigate the effectiveness of a simple and quick myofunctional reeducation protocol of the tongue in reducing the obstructive sleep apnea syndrome (OSAS) severity.
Read the detailed description
This is a randomized controlled study. Participants with moderate OSAS severity will be either allocated to receive a myofunctional reeducation protocol (study group) or a sham protocol (control group). Apnea-hypopnea index (AHI) will be measured before and at the end (6 weeks) of the protocol. Participants from the study group will follow an upper airway reinforcement regimen using the IOPI (Iowa Oral Performance Instrument) device over 6 weeks while participants from the control group will perform a sham reeducation protocol using an "EMT threshold" at minimal resistance.
- Conditions
- Obstructive Sleep Apnea Syndrome
- Being tested
- IOPI, EMT threshold
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOPIDevice
IOPI is a portable device with a tongue bulb used to reinforce upper airway muscles.
EMT thresholdDevice
EMT threshold is a small portable device producing a positive expiratory pressure when the patient is exhaling.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Participants from the study group will follow an upper airway reinforcement regimen using the IOPI device over 6 weeks. The reinforcement protocol will be adapted each week to improve Percentage of initial strength Exercises will be adapted each week Receives: Device: IOPI |
| Control group | Sham comparator | Participants from the control group will perform a sham reeducation protocol using an "EMT threshold" at minimal resistance. The expiratory pressure will remain unchanged over the weeks. Receives: Device: EMT threshold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in AHI (apnea-hypopnea index) on polygraphy
Evolution of the number of apnea-hypopnea events (AHI) over 6 weeks. The AHI value at discharge will be compared with the baseline value.
Measured: Baseline and 6 weeks
Secondary outcomes (2)
Change in tongue strength using the IOPI device
Evolution of tongue strength over 6 weeks. Tongue strength will be measured by asking the participants to squeeze the tongue bulb of IOPI as much as possible over 3 seconds. Three trials are accepted and the best value will be recorded (Pmax). Pmax at discharge will be compared with Pmax at baseline.
Measured: Baseline and 6 weeks
Change in tongue endurance using the IOPI device
Evolution of tongue endurance over 6 weeks. Tongue endurance will be measured by asking the participants to sustain a tongue pressure against the IOPI bulb at 50% of Pmax. Endurance will be assessed by measuring the holding duration of 50% of Pmax. Holding duration at discharge will be compared with the value at baseline.
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start1 Aug 2019
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea SyndromeStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haute Ecole de Santé Vaud
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivier Contal, Haute Ecole de Santé Vaud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03846349
- Sponsor's protocol ID
- UAW strenghtening in OSAS
- Status last verified
- Sep 2019
- First submitted
- 21 Jan 2019
- Last updated
- 28 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Reinforcement of the Upper Airway Dilator Muscles as an Alternative Approach to Treat Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT03846349
- Acronym / sponsor ID
- UAW strenghtening in OSAS
- Conditions
- Obstructive Sleep Apnea Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Haute Ecole de Santé VaudUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 19 Feb 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.
This study will investigate the effectiveness of a simple and quick myofunctional reeducation protocol of the tongue in reducing the obstructive sleep apnea syndrome (OSAS) severity.
Detailed description
This is a randomized controlled study. Participants with moderate OSAS severity will be either allocated to receive a myofunctional reeducation protocol (study group) or a sham protocol (control group). Apnea-hypopnea index (AHI) will be measured before and at the end (6 weeks) of the protocol. Participants from the study group will follow an upper airway reinforcement regimen using the IOPI (Iowa Oral Performance Instrument) device over 6 weeks while participants from the control group will perform a sham reeducation protocol using an "EMT threshold" at minimal resistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Device: IOPIParticipants from the study group will follow an upper airway reinforcement regimen using the IOPI device over 6 weeks. The reinforcement protocol will be adapted each week to improve Percentage of initial strength Exercises will be adapted each week |
| Control group | Sham comparator | Device: EMT thresholdParticipants from the control group will perform a sham reeducation protocol using an "EMT threshold" at minimal resistance. The expiratory pressure will remain unchanged over the weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Moderate obstructive sleep apnea syndrome (AHI between 15 and 30 events per hour)
- Poor adherence to continuous positive airway pressure (< 4h per night)
Key exclusion criteria (4 listed)
- Craniofacial malformation
- Use of hypnotic medication
- Had stroke in the past
- Present a concurrent neuromuscular or severe obstructive nasal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IOPIIOPI is a portable device with a tongue bulb used to reinforce upper airway muscles. | Device | Study Group |
| EMT thresholdEMT threshold is a small portable device producing a positive expiratory pressure when the patient is exhaling. | Device | Control group |
Primary outcome
Change in AHI (apnea-hypopnea index) on polygraphy
Time frame: Baseline and 6 weeks
Evolution of the number of apnea-hypopnea events (AHI) over 6 weeks. The AHI value at discharge will be compared with the baseline value.
2 secondary outcomes
Change in tongue strength using the IOPI device
Time frame: Baseline and 6 weeks
Change in tongue endurance using the IOPI device
Time frame: Baseline and 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2019.
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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.
William Poncin, PhD contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IOPI and EMT threshold in people with Obstructive Sleep Apnea Syndrome, run by Haute Ecole de Santé Vaud at 2 sites in Switzerland.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 28 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivier Contal, PhD (+41213168122, olivier.contal@hesav.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in AHI (apnea-hypopnea index) on polygraphy (time frame: Baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2019.