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

February 19, 2026 updated by: French Cardiology Society

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • France
      • Carquefou, France, France, 44470
        • Recruiting
        • Dr Thierry Garban
        • Contact:
      • Poitiers, France, France, 86000
        • Recruiting
        • CHU de Poitiers
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients consulting in cardiology and cardiologists who participated in CARDIOSOM and perform cardiology consultations

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patient
a prospective, multicentre, national observational survey based on a patient questionnaire designed to quickly detect sleep disorders during a cardiology consultation.
Other: Online questionnaire
Patient oriented Online questionnaire
Other: Online questionnaire
Cardiologist oriented online questionnaire
cardiologist
this is a simple impact survey designed to assess changes in the practices of cardiologists who participated in CARDIOSOM.
Other: Online questionnaire
Patient oriented Online questionnaire
Other: Online questionnaire
Cardiologist oriented online questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
on day 0 (day of completing the online questionnaire)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
online questionnaire completed by the patient
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)
online questionnaire completed by the patient
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)
online questionnaire completed by the patient
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
online questionnaire completed by the cardiologist
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
online questionnaire completed by the cardiologist
at inclusion and one year after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French Cardiology Society

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

February 12, 2026

First Submitted That Met QC Criteria

February 19, 2026

First Posted (Actual)

February 25, 2026

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 19, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-A01666-43

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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