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

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ClinicalTrials.gov Identifier: NCT02494648
Recruitment Status : Recruiting
First Posted : July 10, 2015
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

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.


Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Acute Coronary Syndrome Device: POWERbreathe Fitness Plus, (POWERbreathe International Ltd, UK) [Inspiratory muscles strengthening] Other: Control Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Inspiratory Muscles Strengthening Among Coronary Patients on the Sleep Apnea Obstructive Syndrome (SAOS)
Actual Study Start Date : May 22, 2015
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02494648


Contacts
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Contact: David HUPIN, MD (0)477829109 ext +33 david.hupin@chu-st-etienne.fr

Locations
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France
CHU de Saint-Etienne Recruiting
Saint-etienne, France, 42000
Principal Investigator: David HUPIN, MD         
Sub-Investigator: Frédéric ROCHE, MD-PhD         
Sub-Investigator: Frédéric COSTES, MD         
Sub-Investigator: Jean-Claude BARTHELEMY, MD-PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: David HUPIN, MD CHU de Saint-Etienne

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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02494648     History of Changes
Other Study ID Numbers: 1408189
2015-A00030-49 ( Other Identifier: ANSM )
First Posted: July 10, 2015    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Obstructive sleep apnea
Resistive inspiratory muscle training
Coronary artery disease
Cardiac rehabilitation

Additional relevant MeSH terms:
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Syndrome
Apnea
Sleep Apnea Syndromes
Acute Coronary Syndrome
Respiratory Aspiration
Sleep Apnea, Obstructive
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases