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

Primary Purpose

Sleep Apnea, Obstructive, Acute Coronary Syndrome

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
POWERbreathe Fitness Plus, (POWERbreathe International Ltd, UK) [Inspiratory muscles strengthening]
Control
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring Obstructive sleep apnea, Resistive inspiratory muscle training, Coronary artery disease, Cardiac rehabilitation

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Saint-Etienne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Inspiratory muscles strengthening

Control

Arm Description

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).

No intervention

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Circumference of the neck in centimetre
in centimetre
Epworth questionnaire to evaluate the deficit of sleep
This questionnaire evaluates the deficit of sleep
Pittsburgh questionnaire to evaluate the quality of sleep
This questionnaire evaluates the quality of sleep
SF12 questionnaire to evaluate the quality of life
This questionnaire evaluates the quality of life

Full Information

First Posted
July 8, 2015
Last Updated
February 10, 2022
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT02494648
Brief Title
Effects of Inspiratory Muscles Strengthening Among Coronary Patients on the Sleep Apnea Obstructive Syndrome
Acronym
RICAOS
Official Title
Effects of Inspiratory Muscles Strengthening Among Coronary Patients on the Sleep Apnea Obstructive Syndrome (SAOS)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 22, 2015 (Actual)
Primary Completion Date
June 21, 2021 (Actual)
Study Completion Date
June 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive, Acute Coronary Syndrome
Keywords
Obstructive sleep apnea, Resistive inspiratory muscle training, Coronary artery disease, Cardiac rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inspiratory muscles strengthening
Arm Type
Experimental
Arm Description
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).
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
No intervention
Intervention Type
Device
Intervention Name(s)
POWERbreathe Fitness Plus, (POWERbreathe International Ltd, UK) [Inspiratory muscles strengthening]
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Control
Primary Outcome Measure Information:
Title
AHI Variation
Description
It is the difference between the AHI at the inclusion et the AHI at 6 weeks
Time Frame
At 6 weeks
Secondary Outcome Measure Information:
Title
Circumference of the neck in centimetre
Description
in centimetre
Time Frame
At 6 weeks
Title
Epworth questionnaire to evaluate the deficit of sleep
Description
This questionnaire evaluates the deficit of sleep
Time Frame
at 6 weeks
Title
Pittsburgh questionnaire to evaluate the quality of sleep
Description
This questionnaire evaluates the quality of sleep
Time Frame
At 6 weeks
Title
SF12 questionnaire to evaluate the quality of life
Description
This questionnaire evaluates the quality of life
Time Frame
At 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David HUPIN, MD
Organizational Affiliation
CHU de Saint-Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Saint-Etienne
City
Saint-etienne
ZIP/Postal Code
42000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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