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

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-etienne, France, 42000
    • CHU de Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; No intervention	Other: Control

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: David HUPIN, MD, CHU de Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2015
• Primary Completion (Actual): June 21, 2021
• Study Completion (Actual): June 21, 2021

Study Registration Dates

• First Submitted: July 8, 2015
• First Submitted That Met QC Criteria: July 9, 2015
• First Posted (Estimate): July 10, 2015

Study Record Updates

• Last Update Posted (Actual): February 28, 2022
• Last Update Submitted That Met QC Criteria: February 10, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Coronary artery disease; Obstructive sleep apnea; Cardiac rehabilitation; Resistive inspiratory muscle training
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome; Respiratory Aspiration; Apnea; Acute Coronary Syndrome
• Other Study ID Numbers: 1408189; 2015-A00030-49 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No