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

NCT ID: NCT06568159

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-14
• Study Completion Date: 2026-02-15

Brief 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.

Conditions

Obstructive Sleep Apnea; Coronary Disease; Cardiovascular Diseases

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

MAD group

• An oral and dental check-up will be carried out on the day of inclusion, and a sleep diary will be provided.
• Compliance will be assessed after 6 months' wear.
• As part of the research, specific questionnaires will be completed with the patient during a telephone interview after 6 months: assessment of compliance and quality of life.

No interventions assigned to this group

CPAP group

• An oral and dental check-up will be carried out on the day of inclusion.
• Compliance will be assessed after 6 months' wear.
• As part of the research, specific questionnaires will be completed with the patient during a telephone interview after 6 months: assessment of compliance and quality of life.

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de MONTPELLIER

Montpellier, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Cindy FRANCOIS

Role: CONTACT

c-francois@chu-montpellier.fr

06 84 31 62 08

Facility Contacts

Role: primary

c-francois@chu-montpellier.fr

0467335046

Other Identifiers

RECHMPL23_0168

Identifier Type: -

Identifier Source: org_study_id