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

Not Applicable

Completed

• Conditions: Sleep Apnea, Obstructive; Acute Coronary Syndrome
• Interventions: Device: POWERbreathe Fitness Plus, (POWERbreathe International Ltd, UK) [Inspiratory muscles strengthening]; Other: Control

• Registration Number: NCT02494648
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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

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).

Study Timeline

• Study Start: 2015-05-22
• Study First Submitted: 2015-07-08
• Study First Submitted QC: 2015-07-09
• Study First Posted: 2015-07-10
• Primary Completion: 2021-06-21
• Study Completion: 2021-06-21
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-10
• Last Update Posted: 2022-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inspiratory muscles strengthening	POWERbreathe Fitness Plus, (POWERbreathe International Ltd, UK) [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).
Control	Control	No intervention

Primary Outcome Measures

Name	Time	Method
AHI Variation	At 6 weeks	It is the difference between the AHI at the inclusion et the AHI at 6 weeks

Secondary Outcome Measures

Name	Time	Method
Circumference of the neck in centimetre	At 6 weeks	in centimetre
Epworth questionnaire to evaluate the deficit of sleep	at 6 weeks	This questionnaire evaluates the deficit of sleep
Pittsburgh questionnaire to evaluate the quality of sleep	At 6 weeks	This questionnaire evaluates the quality of sleep
SF12 questionnaire to evaluate the quality of life	At 6 weeks	This questionnaire evaluates the quality of life

Trial Locations

Locations (1)

CHU de Saint-Etienne; 🇫🇷 Saint-etienne, France