Cardiovascular Diseases, Coronary Disease, Obstructive Sleep Apnea
Conditions
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.
Interventions
None listed
Sponsors
University Hospital, Montpellier
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compliance with MAD and CPAP at 6 months (wearing time). | 6 months post-inclusion | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of tolerance and satisfaction with the device used reported by the patient at 6 months (duration of wear) | 6 months post-inclusion | survey : values from 0 to 3. A high score is a better outcome. |
| Clinical parameters of OSA (objective) | 6 months post-inclusion | ventilatory polygraphy or polysomnography |
| Assessment of oral status | the day of inclusion | plaque index : values from 0 to 3. A high score is a worse outcome. |
| Assessment of quality of life | 6 months post-inclusion | Survey WHOQOL Bref. Values : very poor, poor, neither poor nor good, good, very good. |
| Clinical parameters of OSA (subjective) | 6 months post-inclusion | Survey. Values : light, moderate, significant |
Countries
France
Contacts
Primary ContactCindy FRANCOIS
Outcome results
None listed