NCT07432828

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Jan 2026Jan 2027

Study Start

First participant enrolled

January 15, 2026

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 25, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

12 months

First QC Date

February 12, 2026

Last Update Submit

February 19, 2026

Conditions

Sleep Disorder (Disorder)Cardio Vascular Disease

Keywords

sleep disordersrisk of cardiovascular conditionssimplified questionnaire

Outcome Measures

Primary Outcomes (1)

  • Overall prevalence of sleep disorders among patients consulting a cardiologist

    online questionnaire completed by the patient

    on day 0 (day of completing the online questionnaire)

Secondary Outcomes (6)

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

    on day 0 (day of completing the online questionnaire)

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

    on day 0 (day of completing the online questionnaire)

  • Studying the influence of gender on sleep disorders and cardiovascular diseases

    on day 0 (day of completing the online questionnaire)

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

    on day 0 (day of completing the online questionnaire)

  • Assess how often cardiologists routinely ask patients about their sleep quality

    at inclusion and one year after

  • +1 more secondary outcomes

Study Arms (2)

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

cardiologist

this is a simple impact survey designed to assess changes in the practices of cardiologists who participated in CARDIOSOM.

Other: Online questionnaire

Interventions

Online questionnaireOTHER

Patient oriented Online questionnaire

patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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
  • Not applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dr Thierry Garban

Carquefou, France, 44470, France

RECRUITING

CHU de Poitiers

Poitiers, France, 86000, France

RECRUITING

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Central Study Contacts

Dr Thierry Garban

CONTACT

01 44 90 70 28cardiosom@sfcardio.fr

Dr Benoit Lequeux

CONTACT

01 44 90 70 28cardiosom@sfcardio.fr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2026

First Posted

February 25, 2026

Study Start

January 15, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

February 25, 2026

Record last verified: 2026-02

Locations

FR(2)