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NCT Number: NCT02494648

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

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.

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Key information

Conditions

Sleep Apnea, Obstructive Acute Coronary Syndrome Apnea Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Dyssomnias Heart Diseases Myocardial Ischemia Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders Vascular Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Saint-Etienne

Saint-Etienne, 42000, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Other

Primary outcomes

  1. AHI Variation

    Time frame: At 6 weeks

    It is the difference between the AHI at the inclusion et the AHI at 6 weeks

Secondary outcomes

  1. Circumference of the neck in centimetre

    Time frame: At 6 weeks

    in centimetre

  2. Epworth questionnaire to evaluate the deficit of sleep

    Time frame: at 6 weeks

    This questionnaire evaluates the deficit of sleep

  3. Pittsburgh questionnaire to evaluate the quality of sleep

    Time frame: At 6 weeks

    This questionnaire evaluates the quality of sleep

  4. SF12 questionnaire to evaluate the quality of life

    Time frame: At 6 weeks

    This questionnaire evaluates the quality of life

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

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

Acronym: RICAOS

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Jul 10, 2015
Registry last updated
Feb 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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