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

Acute Coronary Syndrome Clinical Trial

— RICAOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02494648
• Other study ID #: 1408189
• Secondary ID: 2015-A00030-49
• Status: Completed
• Phase: N/A
• Start date: May 22, 2015
• Est. completion date: June 21, 2021

Study information

• Verified date: February 2022
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 21, 2021
• Est. primary completion date: June 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Apnea
• Respiratory Aspiration
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

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).

Other:
• Control

Locations

Country	Name	City	State
France	CHU de Saint-Etienne	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AHI Variation	It is the difference between the AHI at the inclusion et the AHI at 6 weeks	At 6 weeks
Secondary	Circumference of the neck in centimetre	in centimetre	At 6 weeks
Secondary	Epworth questionnaire to evaluate the deficit of sleep	This questionnaire evaluates the deficit of sleep	at 6 weeks
Secondary	Pittsburgh questionnaire to evaluate the quality of sleep	This questionnaire evaluates the quality of sleep	At 6 weeks
Secondary	SF12 questionnaire to evaluate the quality of life	This questionnaire evaluates the quality of life	At 6 weeks