Health TrialsbyHealthPanel

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

ConditionObstructive Sleep Apnea
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Saint Etienne

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Inspiratory and Oropharyngeal Muscle Strengthening

    Other intervention

    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.

Treatment groups

38 Participants
are divided into 2 treatment groups
Group A: Strengthening muscles groupExperimental treatment 1 intervention
Group B: No training groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Apnea-Hypopnea Index (AHI)

AHI is measured by polygraphy or polysomnography. It is not a score

Time frame
At 3 months

Secondary outcomes

1

Maximum inspiratory pressure measurement (cmH2O)

Measured by POWERbreathe® K5

Time frame
At 3 and 9 Months
2

Neck circumference (cm)

The neck circumference is measured by Magnetic Resonance Imagery (RMI)

Time frame
At 3 months
3

Epworth sleepiness score

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

Time frame
At 3 and 9 Months
4

Pittsburgh Sleep quality index

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

Time frame
At 3 and 9 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Universitaire de Saint Etienne

Lead sponsor

Association aide à la recherche médicale de proximité (AIRE)

Collaborator

Conseil national de l'ordre des masseurs-kinésithérapeutes

Collaborator

Source ClinicalTrials.gov
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