Strengthening Inspiratory and Oropharyngeal Muscles in Moderate Obstructive Sleep Apnea Hypopnea Syndrome

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

RECRUITING

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-30

Study Completion Date

2026-08-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Strengthening muscles group

Home training to strengthen Inspiratory and Oropharyngeal muscles

Group Type EXPERIMENTAL

Inspiratory and Oropharyngeal Muscle Strengthening

Intervention Type OTHER

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 training group

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No