Effects of Inspiratory Muscles Strengthening Among Coronary Patients on the Sleep Apnea Obstructive Syndrome

Study Overview
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Brief Summary
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Obstructive sleep apnea (OSA) syndrome affects up to 5% of the general population. The prevalence is multiplied by 13 in coronary artery disease (CAD) patients. Many studies have shown that OSA syndrome was the main risk factor for cardiovascular morbidity and mortality (RR = 9.1 [95%, 2.6 to 31.2]). If the value of treatment with Continuous Positive Airway Pressure (CPAP) in symptomatic CAD patients (daytime sleepiness and/or 2 clinical symptoms with Apnea Hypopnea Index (AHI) ≥ 20) appears to be established, treatment with CPAP in asymptomatic CAD patients (with AHI> 30) may be too demanding. Alternative treatments are rare and results are highly variable. Therefore, it would be interesting to suggest other treatment modalities with moderate coronary and/or minimally symptomatic OSA syndrome.

Detailed Description
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This study aims to assess the relevance of inspiratory muscles strengthening on reducing AHI in CAD patients with moderate OSA (AHI between 15 and 30).

Official Title
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Effects of Inspiratory Muscles Strengthening Among Coronary Patients on the Sleep Apnea Obstructive Syndrome (SAOS)

Conditions
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Sleep Apnea, Obstructive, Acute Coronary Syndrome

Intervention / Treatment
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* Device: POWERbreathe Fitness Plus, (POWERbreathe International Ltd, UK) [Inspiratory muscles strengthening]
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with moderate OSA (15 <AHI <30) Period between acute coronary syndrome and inclusion <60 days Patients included in cardiac rehabilitation Exclusion Criteria: Obstructive lung disease with Tiffeneau index less than 70%. Restrictive lung disease with a reduction of total lung capacity (TLC) Treatment for OSA or clinical context (comorbidity) justifying CPAP Congestive heart failure, thoracic surgery by sternotomy Spontaneous pneumothorax Severe Asthma Ruptured eardrum, or another disease of the middle ear, or acute sinusitis

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inspiratory muscles strengthening<br>The device used is : POWERbreathe Fitness Plus, (POWERbreathe International Ltd, UK). Class I, CE labelled. POWERbreathe fitness Plus uses the technique of training against resistance to increase the strength, the power and the endurance of the respiratory muscles (diaphragm and rib cage). | Device: POWERbreathe Fitness Plus, (POWERbreathe International Ltd, UK) [Inspiratory muscles strengthening]<br>* CAD patients participated in a 6-week (20 sessions of training) resistive inspiratory muscle training (RIMT) program for 10 minutes twice daily at a training intensity of 70% of maximum inspiratory pressure (MIP).<br>|
| Placebo Comparator: Control<br>No intervention | Other: Control<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AHI Variation | It is the difference between the AHI at the inclusion et the AHI at 6 weeks | At 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circumference of the neck in centimetre | in centimetre | At 6 weeks | 
| Epworth questionnaire to evaluate the deficit of sleep | This questionnaire evaluates the deficit of sleep | at 6 weeks | 
| Pittsburgh questionnaire to evaluate the quality of sleep | This questionnaire evaluates the quality of sleep | At 6 weeks | 
| SF12 questionnaire to evaluate the quality of life | This questionnaire evaluates the quality of life | At 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obstructive sleep apnea, Resistive inspiratory muscle training, Coronary artery disease, Cardiac rehabilitation