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

NCT ID: NCT02494648

Last Updated: 2022-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-22
• Study Completion Date: 2021-06-21

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).

Conditions

Sleep Apnea, Obstructive; Acute Coronary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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).

Control

No intervention

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: OTHER

Interventions

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).

Intervention Type: DEVICE

Control

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David HUPIN, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

CHU de Saint-Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

2015-A00030-49

Identifier Type: OTHER

Identifier Source: secondary_id

1408189

Identifier Type: -

Identifier Source: org_study_id