Strengthening Inspiratory and Oropharyngeal Muscles in Moderate Obstructive Sleep Apnea Hypopnea Syndrome (REMI SAHOS)

January 28, 2025 updated by: Centre Hospitalier Universitaire de Saint Etienne
The Obstructive Sleep Apnea hypopnea Syndrome (OSAS), whose prevalence is 4% of the French population, can lead to serious health consequences (risk of road accidents, onset of cardiovascular disease, etc.). OSAS corresponds to a certain number of interruptions (apneas) or reductions (hypopneas) of ventilation during sleep. The weakening of the tone of the inspiratory and oropharyngeal muscles is one of the main causes of upper airways obstruction during the inspiratory phase.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

For patients with moderate OSAS, with few or no symptoms, without associated cardiovascular comorbidities, there is no recommended treatment. Rehabilitate the inspiratory and oropharyngeal muscles through muscle strengthening seems to be an alternative to this problem. Therefore, this study proposes a complete rehabilitation care evaluating the effectiveness of the strengthening of inspiratory and oropharyngeal muscles in subject with moderate OSAS.

Study Type

Interventional

Enrollment (Estimated)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Grenoble, France, 38000
        • Not yet recruiting
        • CHU de Grenoble
        • Principal Investigator:
          • Sébastien BAILLIEUL, MD
      • Saint-Étienne, France, 42055
        • Recruiting
        • Centre Hospitalier Universitaire
        • Principal Investigator:
          • Amandine ZELLAG, physiotherapist
        • Sub-Investigator:
          • Pierre LABEIX, physiotherapist

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Moderate SAHOS (15 ≤ AHI ≤30);
  • Body Mass Index (BMI) < 35 ;
  • Patient affiliated or entitled to a social security scheme;
  • Patient having signed a consent to participate in the study.

Exclusion Criteria:

  • Excessive daytime sleepiness: Epworth sleepiness score > 10 ;
  • Professional driving and history of accidents related to sleepiness;
  • Severe obstructive or restrictive ventilatory disorders of neuromuscular origin authenticated by respiratory function tests;
  • Patients undergoing treatment for OSAS or requiring immediate initiation of continuous positive airway pressure (CPAP) or a mandibular advancement orthosis;
  • Patients who have stopped CPAP or orthosis treatment in less than one month;
  • Patients undergoing cardiorespiratory exercise rehabilitation or starting regular physical training;
  • Uncompensated heart failure, thoracic sternotomy surgery < 4 months;
  • Marked osteoporosis with history of rib fractures;
  • History of spontaneous pneumothorax;
  • Severe asthma;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Strengthening muscles group
Home training to strengthen Inspiratory and Oropharyngeal muscles
Other: Inspiratory and Oropharyngeal Muscle Strengthening

Patients will conduct the training at home, 5 days a week for 3 months. They will perform 2 sets of 30 inspirations against resistance (POWERbreathe® K5 , Powerbreathe International Limited, UK), equal to 70% Maximum Inspiratory Pressure (MIP). Patients will be guided for oropharyngeal exercises.

The sessions will be supervised by the investigator every 3 weeks. During sessions with the investigator, sessions recorded in the device will be downloaded to verify compliance. A MIP measurement will be performed to adjust the resistance of the device.
No Intervention: No training group
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apnea-Hypopnea Index (AHI)
Time Frame: At 3 months
AHI is measured by polygraphy or polysomnography. It is not a score
At 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum inspiratory pressure measurement (cmH2O)
Time Frame: At 3 and 9 Months
Measured by POWERbreathe® K5
At 3 and 9 Months
Neck circumference (cm)
Time Frame: At 3 months
The neck circumference is measured by Magnetic Resonance Imagery (RMI)
At 3 months
Epworth sleepiness score
Time Frame: At 3 and 9 Months
Sleep quality assessment using the Epworth sleepiness score. From 0 to 24. If score up to 10 then the patient has signs of excessive daytime sleepiness
At 3 and 9 Months
Pittsburgh Sleep quality index
Time Frame: At 3 and 9 Months
Sleep quality assessment using the Pittsburgh Sleep quality index. From 0 to 21. Score 0 = very good sleep quality. Score 21 = very poor sleep quality
At 3 and 9 Months
PICOT fatigue scale
Time Frame: At 3 and 9 Months
Fatigue assessment using the PICOT scale From 0 to 32 If score up to 22 then the patient has signs of excessive sleepiness
At 3 and 9 Months
Quality of life scale : Short Form 12 (SF12)
Time Frame: At 3 and 9 Months
Quality of life assessment using the scale SF12 From 43 to 118 the higher the score, the better the quality of life
At 3 and 9 Months
AHI (Apnea-Hypopnea Index)
Time Frame: At 9 months
AHI is measured by polygraphy or polysomnography It is not a score
At 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Association aide à la recherche médicale de proximité (AIRE)
Conseil national de l'ordre des masseurs-kinésithérapeutes

Investigators

  • Principal Investigator: Amandine Zellag, CHU Saint-étienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 30, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

June 18, 2024

First Submitted That Met QC Criteria

June 18, 2024

First Posted (Actual)

June 24, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 28, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23GI019
  • 2024-A00601-46 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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