NCT02893865

Brief Summary

Published data indicate that obstructive sleep apnea syndrome (OSAS) worse the prognosis of coronary artery disease (CAD) and that oxidative stress can link this 2 diseases. Investigators hypothesise that oxidative stress decrease after 3 months of continuous positive airway pressure (CPAP) in this specific population. The results may have major implication in the comprehension of physiopathologic processes linking OSAS and CAD and in the treatment of OSAS in this specific population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

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 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2021

Completed
Last Updated

September 30, 2025

Status Verified

October 1, 2021

Enrollment Period

5.2 years

First QC Date

August 4, 2016

Last Update Submit

September 24, 2025

Conditions

Sleep Apnea SyndromeCoronary Artery Disease

Keywords

Apnea syndromeCoronary artery diseaseOxidative stressContinuous positive airway pressureEndothelial dysfunction

Outcome Measures

Primary Outcomes (1)

  • Percentage change of serum GSH/GSSG ratio

    Blood test

    at the inclusion and the end (3 months) of the study

Secondary Outcomes (15)

  • Change, after 3 months, of the SOD (parameter of serum oxidative stress level)

    at the inclusion and the end (3 months) of the study

  • Change, after 3 months, of the catalase (parameters of serum oxidative stress level)

    at the inclusion and the end (3 months) of the study

  • Change, after 3 months, of the Vit C and E (parameters of serum oxidative stress level)

    at the inclusion and the end (3 months) of the study

  • Change, after 3 months, of the isoprostanes (parameter of serum oxidative stress level)

    at the inclusion and the end (3 months) of the study

  • Change, after 3 months, of the 8OHDG (other parameters of serum oxidative stress level)

    at the inclusion and the end (3 months) of the study

  • +10 more secondary outcomes

Study Arms (2)

Experimental

EXPERIMENTAL

Continuous positive airway pressure Patients will receive continuous positive airway pressure during three months

Device: Continuous positive airway pressure

Sham Comparator

SHAM COMPARATOR

Sham-continuous positive airway pressure Patients will receive sham-continuous positive airway pressure during 3 months

Device: Sham-continuous positive airway pressure

Interventions

Continuous positive airway pressureDEVICE

Continuous positive airway pressure treatment during three months with adherence recording

Experimental
Sham-continuous positive airway pressureDEVICE

Sham-continuous positive airway pressure during three months with adherence recording

Sham Comparator

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Apnea Hypopnea Index 15-30/h
  • Stable Coronary artery disease
  • Obligation of obtaining informed consent form

You may not qualify if:

  • Heart failure with LVEF less than or equal to 45%
  • Other Chronic disease: renal failure, COPD Index - central apneas than or equal to 50% of the total IAH
  • treatment with CPAP or mandibular advancement device
  • IMC\> 40 kg / m²
  • Nutritional supplementation in the 4 weeks preceding the study (antioxidants, vitamins ...).
  • Treatment with allopurinol or N-acetylcysteine, in the 4 weeks preceding the study.
  • PaCO2\> 45 mmHg - Counter-indication to the use of PPC: bullous lung disease, pathological hypotension, bypass airway, pneumothorax, signs of sinus infections or inner ear
  • Participation of the subject to another study.
  • Not affiliated with a social security scheme subject or not the beneficiary of such a regime.
  • Pregnant or breastfeeding women, patient unable to give consent, protected adult, vulnerable
  • Subject deprived of liberty by judicial or administrative decision
  • HIV infection, hepatitis B or hepatitis C known

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU of Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Sleep Apnea SyndromesCoronary Artery Disease

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2016

First Posted

September 9, 2016

Study Start

May 1, 2016

Primary Completion

July 1, 2021

Study Completion

July 29, 2021

Last Updated

September 30, 2025

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)