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NCT Number: NCT07432828

Assessment of the Association Between Sleep Disorders Detected by a Simplified Questionnaire and Cardiovascular Diseases

The goal of this observational study is to validate a simplified questionnaire, adapted for routine clinical use, to quickly detect sleep disorders in patient during a cardiology consultation.

Two questionnaires were developed for this project. The first is patient-oriented: a prospective, multicentre, national observational registry based on a patient questionnaire designed to quickly detect sleep disorders during a cardiology consultation.

The second is aimed at treating cardiologists: this is a simple impact survey designed to assess changes in the practices of cardiologists who participated in CARDIOSOM.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr Thierry Garban, Carquefou, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

- Patient :

  • Adult patients (≥18 years old) consulting in cardiology.
  • Ability to complete the questionnaire.
  • No objection

Inclusion criteria

- Cardiologist:

Cardiologists who participated in CARDIOSOM and who conduct cardiology consultations that include a systematic or non-systematic assessment of their patients' sleep quality (duration, regularity, insomnia, sleepiness, suspected obstructive sleep apnea (OSA)) and whether or not suspected sleep disorders in patients are treated.

Exclusion criteria

- Patient :

  • Active treatment for a severe sleep disorder (severe sleep apnea under CPAP (Continuous Positive Airway Pressure) or orthotic device, narcolepsy, chronic insomnia being treated)
  • Refusal to participate

Exclusion criteria

- Cardiologist :

Not applicable

Treatment and study plan

Online Questionnaire

Other

Patient oriented Online questionnaire

Primary outcomes

  1. Overall prevalence of sleep disorders among patients consulting a cardiologist

    Time frame: on day 0 (day of completing the online questionnaire)

    online questionnaire completed by the patient

Secondary outcomes

  1. Describe the sleep complaints and disorders reported by patients consulting a cardiologist.

    Time frame: on day 0 (day of completing the online questionnaire)

    online questionnaire completed by the patient

  2. Identify the types of sleep disorders associated with the presence of cardiovascular diseases.

    Time frame: on day 0 (day of completing the online questionnaire)

    online questionnaire completed by the patient

  3. Studying the influence of gender on sleep disorders and cardiovascular diseases

    Time frame: on day 0 (day of completing the online questionnaire)

    online questionnaire completed by the patient

  4. Studying the influence of socioeconomic determinants on sleep disorders and cardiovascular diseases

    Time frame: on day 0 (day of completing the online questionnaire)

    online questionnaire completed by the patient

  5. Assess how often cardiologists routinely ask patients about their sleep quality

    Time frame: at inclusion and one year after

    online questionnaire completed by the cardiologist

  6. Determine whether or not to treat suspected sleep disorders in patients during their cardiology consultations.

    Time frame: at inclusion and one year after

    online questionnaire completed by the cardiologist

Study contacts

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

Dr Benoit Lequeux

CONTACT

[email protected]

01 44 90 70 28 ext. +33

Dr Thierry Garban

CONTACT

[email protected]

01 44 90 70 28 ext. +33

Sponsors and collaborators

Lead sponsor

French Cardiology Society

Other

Collaborators

  • Collège National des Cardiologues Français
  • Collège National des Cardiologues des Hôpitaux
  • Société Française de Recherche et Médecine du Sommeil (S.F.R.M.S)
  • Syndicat National des Cardiologues

Registry information

Official study title

Assessment of the Association Between Sleep Disorders Detected by a Simplified Questionnaire and Cardiovascular Diseases: a Prospective Study in Cardiology Consultations

Acronym: CARDIOSOM

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 25, 2026
Registry last updated
Feb 25, 2026

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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