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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Coronary Disease; Obstructive Sleep Apnea

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Cindy FRANCOIS; Phone Number: 06 84 31 62 08; Email: c-francois@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France, 34090
    • Recruiting
    • CHU de Montpellier
    • Contact: Phone Number: 0467335046; Email: c-francois@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects aged over 18, suffering from moderate to severe OSA and with CV pathology or at high risk of developing it.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance with MAD and CPAP at 6 months (wearing time).	MAD compliance at 6 months (wearing time): a sleep diary will be given to the patient at the inclusion visit. CPAP compliance at 6 months: data transmitted by the CPAP device (sleep diary).	6 months post-inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical parameters of OSA (objective)	ventilatory polygraphy or polysomnography	6 months post-inclusion
Assessment of oral status	plaque index : values from 0 to 3. A high score is a worse outcome.	the day of inclusion
Assessment of oral status	mobility index : values from 1 to 4. A high score is a worse outcome.	the day of inclusion
Assessment of oral status	bleeding index : values from 0 to 1 (100%). A high score is a worse outcome.	the day of inclusion
Assessment of tolerance and satisfaction with the device used reported by the patient at 6 months (duration of wear)	survey : values from 0 to 3. A high score is a better outcome.	6 months post-inclusion
Assessment of quality of life	Survey WHOQOL Bref. Values : very poor, poor, neither poor nor good, good, very good.	6 months post-inclusion
Clinical parameters of OSA (subjective)	Survey. Values : light, moderate, significant	6 months post-inclusion

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2025
• Primary Completion (Estimated): February 14, 2026
• Study Completion (Estimated): February 15, 2026

Study Registration Dates

• First Submitted: July 26, 2024
• First Submitted That Met QC Criteria: August 20, 2024
• First Posted (Actual): August 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 17, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Vascular Diseases; Heart Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Arteriosclerosis; Arterial Occlusive Diseases; Cardiovascular Diseases; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: RECHMPL23_0168

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No