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

Last updated: February 17, 2025
Sponsor: University Hospital, Montpellier
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sleep Apnea Syndromes

Atherosclerosis

Heart Disease

Treatment

N/A

Clinical Study ID

NCT06568159
RECHMPL23_0168
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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, emergingfactors including anxiety-depression, shift workers, etc.).

  • Hypertensive patients at high cardiovascular risk (target organ damage such as LVHor albuminuria)

  • Diabetic patients at high cardiovascular risk

  • Type of heart disease: ischaemic heart disease without clinically significant heartfailure (NYHA II, III, IV) For the experimental group (MAD): patients with moderateor 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

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.

Study Design

Total Participants: 60
Study Start date:
February 14, 2025
Estimated Completion Date:
February 15, 2026

Connect with a study center

  • CHU de MONTPELLIER

    Montpellier, 34090
    France

    Active - Recruiting

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