NCT02494648

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 22, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 10, 2015

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2021

Completed
Last Updated

February 28, 2022

Status Verified

February 1, 2022

Enrollment Period

6.1 years

First QC Date

July 8, 2015

Last Update Submit

February 10, 2022

Conditions

Sleep Apnea, ObstructiveAcute Coronary Syndrome

Keywords

Obstructive sleep apneaResistive inspiratory muscle trainingCoronary artery diseaseCardiac rehabilitation

Outcome Measures

Primary Outcomes (1)

  • AHI Variation

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

    At 6 weeks

Secondary Outcomes (4)

  • Circumference of the neck in centimetre

    At 6 weeks

  • Epworth questionnaire to evaluate the deficit of sleep

    at 6 weeks

  • Pittsburgh questionnaire to evaluate the quality of sleep

    At 6 weeks

  • SF12 questionnaire to evaluate the quality of life

    At 6 weeks

Study Arms (2)

Inspiratory muscles strengthening

EXPERIMENTAL

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]

Control

PLACEBO COMPARATOR

No intervention

Other: Control

Interventions

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).

Inspiratory muscles strengthening
ControlOTHER
Control

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with moderate OSA (15 \<AHI \<30)
  • Patients included in cardiac rehabilitation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42000, France

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveAcute Coronary SyndromeCoronary Artery Disease

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Study Officials

  • David HUPIN, MD

    CHU de Saint-Etienne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2015

First Posted

July 10, 2015

Study Start

May 22, 2015

Primary Completion

June 21, 2021

Study Completion

June 21, 2021

Last Updated

February 28, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)