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

Centre Hospitalier Universitaire de Saint Etienne

Status: Completed

Conditions: Acute Coronary Syndrome; Sleep Apnea, Obstructive

Treatments: Device: POWERbreathe Fitness Plus, (POWERbreathe International Ltd, UK) [Inspiratory muscles strengthening]; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT02494648

1408189

2015-A00030-49 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 48 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups, including a placebo group

Inspiratory muscles strengthening

Experimental group

Description:

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).

Treatment:

Device: POWERbreathe Fitness Plus, (POWERbreathe International Ltd, UK) [Inspiratory muscles strengthening]

Control

Placebo Comparator group

Description:

No intervention

Treatment:

Other: Control