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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 6, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Tracking Information
First Submitted Date  ICMJE July 8, 2015
First Posted Date  ICMJE July 10, 2015
Last Update Posted Date February 6, 2020
Actual Study Start Date  ICMJE May 22, 2015
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2015)
AHI Variation [ Time Frame: At 6 weeks ]
It is the difference between the AHI at the inclusion et the AHI at 6 weeks
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2015)
  • Circumference of the neck in centimetre [ Time Frame: At 6 weeks ]
    in centimetre
  • Epworth questionnaire to evaluate the deficit of sleep [ Time Frame: at 6 weeks ]
    This questionnaire evaluates the deficit of sleep
  • Pittsburgh questionnaire to evaluate the quality of sleep [ Time Frame: At 6 weeks ]
    This questionnaire evaluates the quality of sleep
  • SF12 questionnaire to evaluate the quality of life [ Time Frame: At 6 weeks ]
    This questionnaire evaluates the quality of life
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Inspiratory Muscles Strengthening Among Coronary Patients on the Sleep Apnea Obstructive Syndrome
Official Title  ICMJE Effects of Inspiratory Muscles Strengthening Among Coronary Patients on the Sleep Apnea Obstructive Syndrome (SAOS)
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Sleep Apnea, Obstructive
  • Acute Coronary Syndrome
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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).

    Intervention: Device: POWERbreathe Fitness Plus, (POWERbreathe International Ltd, UK) [Inspiratory muscles strengthening]
  • Placebo Comparator: Control
    No intervention
    Intervention: Other: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 9, 2015)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: David HUPIN, MD (0)477829109 ext +33 david.hupin@chu-st-etienne.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02494648
Other Study ID Numbers  ICMJE 1408189
2015-A00030-49 ( Other Identifier: ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre Hospitalier Universitaire de Saint Etienne
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Saint Etienne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David HUPIN, MD CHU de Saint-Etienne
PRS Account Centre Hospitalier Universitaire de Saint Etienne
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP