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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02494648
Acronym
RICAOS
Enrollment
48
Registered
2015-07-10
Start date
2015-05-22
Completion date
2021-06-21
Last updated
2022-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome, Sleep Apnea, Obstructive

Keywords

Obstructive sleep apnea, Resistive inspiratory muscle training, Coronary artery disease, Cardiac rehabilitation

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).

Interventions

DEVICEPOWERbreathe 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).

OTHERControl

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
AHI VariationAt 6 weeksIt is the difference between the AHI at the inclusion et the AHI at 6 weeks

Secondary

MeasureTime frameDescription
Circumference of the neck in centimetreAt 6 weeksin centimetre
Epworth questionnaire to evaluate the deficit of sleepat 6 weeksThis questionnaire evaluates the deficit of sleep
Pittsburgh questionnaire to evaluate the quality of sleepAt 6 weeksThis questionnaire evaluates the quality of sleep
SF12 questionnaire to evaluate the quality of lifeAt 6 weeksThis questionnaire evaluates the quality of life

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026