Clinical trial NCT06568159: Patients with Coronary Artery Disease or At High Cardiovascular Risk: Measuring Compliance with Treatment for Obstructive Sleep Apnea Syndrome
Official title: Patients with Coronary Artery Disease or At High Cardiovascular Risk: Measuring Compliance with Treatment for Obstructive Sleep Apnea Syndrome (OAM or CPAP)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obstructive Sleep Apnea
Coronary Disease
Cardiovascular Diseases
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2024-08-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Compliance with MAD and CPAP at 6 months (wearing time).
timeFrame: 6 months post-inclusion
Secondary outcomes:
measure: Assessment of oral status
timeFrame: the day of inclusion
measure: Assessment of oral status
timeFrame: the day of inclusion
measure: Assessment of oral status
timeFrame: the day of inclusion
measure: Assessment of tolerance and satisfaction with the device used reported by the patient at 6 months (duration of wear)
timeFrame: 6 months post-inclusion
measure: Clinical parameters of OSA (objective)
timeFrame: 6 months post-inclusion
measure: Assessment of quality of life
timeFrame: 6 months post-inclusion
measure: Clinical parameters of OSA (subjective)
timeFrame: 6 months post-inclusion
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU de MONTPELLIER
Study officials:
References: