Sleep Disorder (Disorder)CARDIOSOMNCT07432828
Assessment of the Association Between Sleep Disorders Detected by a Simplified Questionnaire and Cardiovascular Diseases
An observational study of Sleep Disorder (Disorder) and Cardio Vascular Disease, run by French Cardiology Society at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disorder (Disorder), Cardio Vascular Disease
- What is being tested?
- Online questionnaire
- How many people
- 1,500 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Jan 2026to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients consulting in cardiology and cardiologists who participated in CARDIOSOM and perform cardiology consultations
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Dr Thierry Garban
Carquefou, France, 44470
Dr Thierry Garban, 01 44 90 70 28 ext. +33, cardiosom@sfcardio.fr
- Recruiting
CHU de Poitiers
Poitiers, France, 86000
Dr Benoit Lequeux, 01 44 90 70 28 ext. +33, cardiosom@sfcardio.fr
About this study
Official title: 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.
- Conditions
- Sleep Disorder (Disorder), Cardio Vascular Disease
- Being tested
- Online questionnaire
- Keywords
- sleep disorders, risk of cardiovascular conditions, simplified questionnaire
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online questionnaireOther
Patient oriented Online questionnaire
Online questionnaireOther
Cardiologist oriented online questionnaire
| Study group | Role | What they receive |
|---|---|---|
| patient | a prospective, multicentre, national observational survey based on a patient questionnaire designed to quickly detect sleep disorders during a cardiology consultation. Receives: Other: Online questionnaire | |
| cardiologist | this is a simple impact survey designed to assess changes in the practices of cardiologists who participated in CARDIOSOM. Receives: Other: Online questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall prevalence of sleep disorders among patients consulting a cardiologist
online questionnaire completed by the patient
Measured: on day 0 (day of completing the online questionnaire)
Secondary outcomes (6)
Describe the sleep complaints and disorders reported by patients consulting a cardiologist.
online questionnaire completed by the patient
Measured: on day 0 (day of completing the online questionnaire)
Identify the types of sleep disorders associated with the presence of cardiovascular diseases.
online questionnaire completed by the patient
Measured: on day 0 (day of completing the online questionnaire)
Studying the influence of gender on sleep disorders and cardiovascular diseases
online questionnaire completed by the patient
Measured: on day 0 (day of completing the online questionnaire)
Studying the influence of socioeconomic determinants on sleep disorders and cardiovascular diseases
online questionnaire completed by the patient
Measured: on day 0 (day of completing the online questionnaire)
Assess how often cardiologists routinely ask patients about their sleep quality
online questionnaire completed by the cardiologist
Measured: at inclusion and one year after
Determine whether or not to treat suspected sleep disorders in patients during their cardiology consultations.
online questionnaire completed by the cardiologist
Measured: at inclusion and one year after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start15 Jan 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disorder (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Collaborators
- Collège National des Cardiologues Français, Syndicat National des Cardiologues, Collège National des Cardiologues des Hôpitaux, Société Française de Recherche et Médecine du Sommeil (S.F.R.M.S)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07432828
- Sponsor's protocol ID
- 2025-A01666-43
- Acronym
- CARDIOSOM
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Association Between Sleep Disorders Detected by a Simplified Questionnaire and Cardiovascular Diseases: a Prospective Study in Cardiology Consultations
- ClinicalTrials.gov ID
- NCT07432828
- Acronym / sponsor ID
- CARDIOSOM / 2025-A01666-43
- Conditions
- Sleep Disorder (Disorder), Cardio Vascular Disease
- Keywords
- sleep disorders, risk of cardiovascular conditions, simplified questionnaire
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Collaborators
- Collège National des Cardiologues Français, Syndicat National des Cardiologues, Collège National des Cardiologues des Hôpitaux, Société Française de Recherche et Médecine du Sommeil (S.F.R.M.S)
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient | – | Other: Online questionnairea prospective, multicentre, national observational survey based on a patient questionnaire designed to quickly detect sleep disorders during a cardiology consultation. |
| cardiologist | – | Other: Online questionnairethis is a simple impact survey designed to assess changes in the practices of cardiologists who participated in CARDIOSOM. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients consulting in cardiology and cardiologists who participated in CARDIOSOM and perform cardiology consultations
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online questionnairePatient oriented Online questionnaire | Other | patient |
| Online questionnaireCardiologist oriented online questionnaire | Other | cardiologist |
Primary outcome
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
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disorder (Disorder) and Cardio Vascular Disease, run by French Cardiology Society at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Thierry Garban (01 44 90 70 28 ext. +33, cardiosom@sfcardio.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall prevalence of sleep disorders among patients consulting a cardiologist (time frame: on day 0 (day of completing the online questionnaire)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.