Actively Recruiting

Age: 18Years +
All Genders
NCT06568159

Patients with Coronary Artery Disease or At High Cardiovascular Risk: Measuring Compliance with Treatment for Obstructive Sleep Apnea Syndrome

Led by University Hospital, Montpellier · Updated on 2025-02-18

60

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Obstructive sleep apnea (OSA) is a sleep disorder characterised by partial or total obstruction of the oro-pharyngeal carrefour during sleep. It is found in between 4% and 25% of the general population and in 40 to 80% of patients with cardiovascular diseases. Continuous positive airway pressure (CPAP) is the standard treatment for OSA and its efficacy has already been demonstrated in this particular population. However, this treatment is not always accepted or sufficiently tolerated. The mandibular advancement device (MAD) is therefore an alternative treatment for OSA, validated by the French National Authority for Health and particularly relevant in this population because it is generally better tolerated. The aim of our study was to assess compliance, tolerance and usability of CPAP and MAD in patients with coronary artery disease and moderate (Apnea-Hypopnea Index AHI 15-30) to severe (AHI\>30) OSA.

CONDITIONS

Official Title

Patients with Coronary Artery Disease or At High Cardiovascular Risk: Measuring Compliance with Treatment for Obstructive Sleep Apnea Syndrome

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults with coronary artery disease, with or without additional conditions like smoking, diabetes, hypertension, dyslipidaemia, kidney issues, overweight, anxiety-depression, or shift work
  • Hypertensive patients at high cardiovascular risk with target organ damage such as left ventricular hypertrophy or albuminuria
  • Diabetic patients at high cardiovascular risk
  • Patients with ischaemic heart disease without clinically significant heart failure (NYHA II, III, IV)
  • Patients with moderate or severe obstructive sleep apnea (OSA) who either use CPAP or, if intolerant or refusing CPAP, are managed with mandibular advancement device (MAD)
Not Eligible

You will not qualify if you...

  • Patients with unstable heart failure (NYHA IV) as judged by the investigator
  • Patients with severe psychiatric disorders
  • Pregnant or breastfeeding women
  • Individuals who oppose participation after reflection
  • People not affiliated with a social security scheme
  • Persons under legal protection such as court protection, guardianship, or curatorship
  • Participants currently involved in another study with an active exclusion period
  • Individuals unable to follow the study procedures during the study period

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

CHU de MONTPELLIER

Montpellier, France, 34090

Actively Recruiting

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Research Team

C

Cindy FRANCOIS

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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