Effects of Inspiratory Muscles Strengthening Among Coronary Patients on the Sleep Apnea Obstructive Syndrome (RICAOS)
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|ClinicalTrials.gov Identifier: NCT02494648|
Recruitment Status : Recruiting
First Posted : July 10, 2015
Last Update Posted : February 19, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea, Obstructive Acute Coronary Syndrome||Device: POWERbreathe Fitness Plus, (POWERbreathe International Ltd, UK) [Inspiratory muscles strengthening] Other: Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Inspiratory Muscles Strengthening Among Coronary Patients on the Sleep Apnea Obstructive Syndrome (SAOS)|
|Actual Study Start Date :||May 22, 2015|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||March 2020|
Experimental: Inspiratory muscles strengthening
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]
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).
Placebo Comparator: Control
- AHI Variation [ Time Frame: At 6 weeks ]It is the difference between the AHI at the inclusion et the AHI at 6 weeks
- Circumference of the neck in centimetre [ Time Frame: At 6 weeks ]in centimetre
- Epworth questionnaire to evaluate the deficit of sleep [ Time Frame: at 6 weeks ]This questionnaire evaluates the deficit of sleep
- Pittsburgh questionnaire to evaluate the quality of sleep [ Time Frame: At 6 weeks ]This questionnaire evaluates the quality of sleep
- SF12 questionnaire to evaluate the quality of life [ Time Frame: At 6 weeks ]This questionnaire evaluates the quality of life
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02494648
|Contact: David HUPIN, MD||(0)477829109 ext +firstname.lastname@example.org|
|CHU de Saint-Etienne||Recruiting|
|Saint-etienne, France, 42000|
|Principal Investigator: David HUPIN, MD|
|Sub-Investigator: Frédéric ROCHE, MD-PhD|
|Sub-Investigator: Frédéric COSTES, MD|
|Sub-Investigator: Jean-Claude BARTHELEMY, MD-PhD|
|Principal Investigator:||David HUPIN, MD||CHU de Saint-Etienne|