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Recruiting NCT07432828

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

— Observational Sleep Disorder (Disorder) Cardio Vascular Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Online questionnaire, Online questionnaire.
Who it may be relevant to
Registry conditions: Sleep Disorder (Disorder), Cardio Vascular Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Other Online questionnaire
    Patient oriented Online questionnaire
  • Other Online questionnaire
    Cardiologist oriented online questionnaire

Primary outcome measures

  • Overall prevalence of sleep disorders among patients consulting a cardiologist [Time frame: on day 0 (day of completing the online questionnaire)]
Secondary outcome measures (6)
  • Describe the sleep complaints and disorders reported by patients consulting a cardiologist. [Time frame: on day 0 (day of completing the online questionnaire)]
  • Identify the types of sleep disorders associated with the presence of cardiovascular diseases. [Time frame: on day 0 (day of completing the online questionnaire)]
  • Studying the influence of gender on sleep disorders and cardiovascular diseases [Time frame: on day 0 (day of completing the online questionnaire)]
  • Studying the influence of socioeconomic determinants on sleep disorders and cardiovascular diseases [Time frame: on day 0 (day of completing the online questionnaire)]
  • Assess how often cardiologists routinely ask patients about their sleep quality [Time frame: at inclusion and one year after]
  • Determine whether or not to treat suspected sleep disorders in patients during their cardiology consultations. [Time frame: at inclusion and one year after]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

France · 2 centers
  • Dr Thierry Garban — Carquefou
  • CHU de Poitiers — Poitiers

Identifiers

NCT: NCT07432828 · 2025-A01666-43

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗