Reinforcement of Upper Airway Muscles in Patients With OSAS
Primary Purpose
Obstructive Sleep Apnea Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
IOPI
EMT threshold
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea Syndrome
Eligibility Criteria
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
Sites / Locations
- Ligue Pulmonaire Genevoise
- Haute Ecole de Santé Vaud (HESAV)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Study Group
Control group
Arm Description
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
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03846349
First Posted
January 21, 2019
Last Updated
October 25, 2019
Sponsor
Haute Ecole de Santé Vaud
1. Study Identification
Unique Protocol Identification Number
NCT03846349
Brief Title
Reinforcement of Upper Airway Muscles in Patients With OSAS
Official Title
Non-invasive Reinforcement of the Upper Airway Dilator Muscles as an Alternative Approach to Treat Patients With Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Anticipated)
Study Completion Date
July 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Haute Ecole de Santé Vaud
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study Group
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
IOPI
Intervention Description
IOPI is a portable device with a tongue bulb used to reinforce upper airway muscles.
Intervention Type
Device
Intervention Name(s)
EMT threshold
Intervention Description
EMT threshold is a small portable device producing a positive expiratory pressure when the patient is exhaling.
Primary Outcome Measure Information:
Title
Change in AHI (apnea-hypopnea index) on polygraphy
Description
Evolution of the number of apnea-hypopnea events (AHI) over 6 weeks. The AHI value at discharge will be compared with the baseline value.
Time Frame
Baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Change in tongue strength using the IOPI device
Description
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.
Time Frame
Baseline and 6 weeks
Title
Change in tongue endurance using the IOPI device
Description
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.
Time Frame
Baseline and 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olivier Contal, PhD
Phone
+41213168122
Email
olivier.contal@hesav.ch
First Name & Middle Initial & Last Name or Official Title & Degree
William Poncin, PhD
Email
william.poncin@uclouvain.be
Facility Information:
Facility Name
Ligue Pulmonaire Genevoise
City
Genève
ZIP/Postal Code
1205
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Contal, PhD
Phone
+41213168122
Email
olivier.contal@hesav.ch
Facility Name
Haute Ecole de Santé Vaud (HESAV)
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Contal, PhD
Phone
+41213168122
Email
olivier.contal@uclouvain.be
First Name & Middle Initial & Last Name & Degree
William Poncin, PhD
12. IPD Sharing Statement
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Reinforcement of Upper Airway Muscles in Patients With OSAS
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