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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Montpellier

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

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

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

60 Participants
are grouped into 2 trial groups
Group A: MAD group
Group B: CPAP group

Trial outcomes

Primary outcomes

1

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).

Time frame
6 months post-inclusion

Secondary outcomes

1

Assessment of oral status

plaque index : values from 0 to 3. A high score is a worse outcome.

Time frame
the day of inclusion
2

Assessment of oral status

mobility index : values from 1 to 4. A high score is a worse outcome.

Time frame
the day of inclusion
3

Assessment of oral status

bleeding index : values from 0 to 1 (100%). A high score is a worse outcome.

Time frame
the day of inclusion
4

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.

Time frame
6 months post-inclusion

Other outcomes

Sponsors and contacts

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