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NCT Number: NCT06568159

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

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Cardiovascular Diseases Coronary Disease Dyssomnias Heart Diseases Myocardial Ischemia Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Compliance with MAD and CPAP at 6 months (wearing time).

    Time frame: 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 outcomes

  1. Assessment of oral status

    Time frame: the day of inclusion

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

  2. Assessment of oral status

    Time frame: the day of inclusion

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

  3. Assessment of oral status

    Time frame: the day of inclusion

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

  4. Assessment of tolerance and satisfaction with the device used reported by the patient at 6 months (duration of wear)

    Time frame: 6 months post-inclusion

    survey : values from 0 to 3. A high score is a better outcome.

  5. Clinical parameters of OSA (objective)

    Time frame: 6 months post-inclusion

    ventilatory polygraphy or polysomnography

  6. Assessment of quality of life

    Time frame: 6 months post-inclusion

    Survey WHOQOL Bref. Values : very poor, poor, neither poor nor good, good, very good.

  7. Clinical parameters of OSA (subjective)

    Time frame: 6 months post-inclusion

    Survey. Values : light, moderate, significant

Study contacts

Contact information is provided by the study sponsor or research team.

Cindy FRANCOIS

CONTACT

[email protected]

06 84 31 62 08

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: PACOAM

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 23, 2024
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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