Reinforcement of Upper Airway Muscles in Patients With OSAS

NCT ID: NCT03846349

Last Updated: 2019-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2020-07-01

Brief Summary

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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

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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

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Obstructive Sleep Apnea Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Study Group

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

Group Type EXPERIMENTAL

IOPI

Intervention Type DEVICE

IOPI is a portable device with a tongue bulb used to reinforce upper airway muscles.

Control group

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.

Group Type SHAM_COMPARATOR

EMT threshold

Intervention Type DEVICE

EMT threshold is a small portable device producing a positive expiratory pressure when the patient is exhaling.

Interventions

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IOPI

IOPI is a portable device with a tongue bulb used to reinforce upper airway muscles.

Intervention Type DEVICE

EMT threshold

EMT threshold is a small portable device producing a positive expiratory pressure when the patient is exhaling.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Moderate obstructive sleep apnea syndrome (AHI between 15 and 30 events per hour)
* Poor adherence to continuous positive airway pressure (\< 4h per night)

Exclusion Criteria

* Craniofacial malformation
* Use of hypnotic medication
* Had stroke in the past
* Present a concurrent neuromuscular or severe obstructive nasal disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Haute Ecole de Santé Vaud

OTHER

Sponsor Role lead

Responsible Party

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Olivier Contal

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ligue Pulmonaire Genevoise

Geneva, , Switzerland

Site Status NOT_YET_RECRUITING

Haute Ecole de Santé Vaud (HESAV)

Lausanne, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Olivier Contal, PhD

Role: CONTACT

+41213168122

William Poncin, PhD

Role: CONTACT

Facility Contacts

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Olivier Contal, PhD

Role: primary

+41213168122

Olivier Contal, PhD

Role: primary

+41213168122

Other Identifiers

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UAW strenghtening in OSAS

Identifier Type: -

Identifier Source: org_study_id

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