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Measuring how well heart patients with sleep apnea use CPAP or a mouthpiece device

Studies how well heart patients with sleep apnea use CPAP or a mouthpiece device.

Key facts

Who runs it
University Hospital, Montpellier
Where
Montpellier, FranceSee the site
Trial code
Registry title
Patients with Coronary Artery Disease or At High Cardiovascular Risk: Measuring Compliance with Treatment for Obstructive Sleep Apnea Syndrome
Status
Recruiting
People taking part
60 people, planned
Started
14 Feb 2025
Planned end
15 Feb 2026
Type of study
Observational, 2 groups
Record updated
18 February 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with coronary artery disease or very high heart risk, who have moderate or severe obstructive sleep apnea and use CPAP or a mandibular advancement device (MAD).

Age
18 years and older
Sex
All
Disease stage
Moderate or severe obstructive sleep apnea (AHI 15-30 is moderate, AHI>30 is severe), with coronary artery disease or very high cardiovascular risk. Heart disease without clinically significant heart failure (NYHA II, III, IV).
Earlier treatment
MAD group: people who cannot tolerate or refuse CPAP and are treated with MAD. CPAP group: people treated with CPAP.

Main reasons for not taking part

  • Heart failure that is not stable (NYHA IV)
  • Severe psychiatric disorders
  • Pregnant or breast-feeding women
  • Taking part in another study with an exclusion period still running
  • Cannot be followed during the study period

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in France

  • CHU de MontpellierMontpellier, FranceContact: Cindy FRANCOISTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • 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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Patients with Coronary Artery Disease or At High Cardiovascular Risk: Measuring Compliance with Treatment for Obstructive Sleep Apnea Syndrome (OAM or CPAP)
Plain-language title
Measuring how well heart patients with sleep apnea use CPAP or a mouthpiece deviceGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
18 February 2025