Menu
Recruiting NCT06568159

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

— Observational Obstructive Sleep Apnea Coronary Disease Cardiovascular Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Obstructive Sleep Apnea, Coronary Disease, Cardiovascular Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

  • Compliance with MAD and CPAP at 6 months (wearing time). [Time frame: 6 months post-inclusion]
Secondary outcome measures (7)
  • Assessment of oral status [Time frame: the day of inclusion]
  • Assessment of oral status [Time frame: the day of inclusion]
  • Assessment of oral status [Time frame: the day of inclusion]
  • Assessment of tolerance and satisfaction with the device used reported by the patient at 6 months (duration of wear) [Time frame: 6 months post-inclusion]
  • Clinical parameters of OSA (objective) [Time frame: 6 months post-inclusion]
  • Assessment of quality of life [Time frame: 6 months post-inclusion]
  • Clinical parameters of OSA (subjective) [Time frame: 6 months post-inclusion]

Eligibility criteria

Inclusion criteria

Target population: with coronary artery disease or at very high risk of coronary artery disease:

  • Patients with coronary artery disease with or without co-morbidities (smoking, diabetes, hypertension, dyslipidaemia, renal insufficiency, overweight, emerging factors including anxiety-depression, shift workers, etc.).
  • Hypertensive patients at high cardiovascular risk (target organ damage such as LVH or albuminuria)
  • Diabetic patients at high cardiovascular risk
  • Type of heart disease: ischaemic heart disease without clinically significant heart failure (NYHA II, III, IV) For the experimental group (MAD): patients with moderate or severe OSA with intolerance or refusal of CPAP and managed by MAD.

For the control group (CPAP): patients with moderate or severe OSA treated with CPAP.

Exclusion criteria

  • Patients with heart failure not stabilised according to the investigator (NYHA IV)
  • Severe psychiatric disorders
  • Pregnant or breast-feeding women
  • Opposition to participation after a period of reflection
  • Not affiliated to a social security scheme,
  • Persons under court protection,
  • Persons under guardianship or curatorship
  • Person taking part in another study with an exclusion period still in progress
  • Inability to follow the patient during the study period.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

France · 1 center
  • CHU de MONTPELLIER — Montpellier

Identifiers

NCT: NCT06568159 · RECHMPL23_0168

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗