Link between sleep problems found with a brief questionnaire and heart disease
Assessment of the Association Between Sleep Disorders Detected by a Simplified Questionnaire and Cardiovascular Diseases: a Prospective Study in Cardiology Consultations
This project tests whether a short questionnaire used during cardiology visits can quickly find sleep problems related to cardiovascular disease in adult cardiology patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | French Cardiology Society Academic / other |
| Locations | 2 sites (Carquefou, France and 1 other locations) |
| Trial ID | NCT07432828 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter, national observational registry that uses a patient-facing online questionnaire to detect sleep disorders during cardiology consultations and a separate survey for participating cardiologists to document practice change. Adult cardiology patients who can complete the questionnaire and are not on active treatment for severe sleep disorders are enrolled at participating French cardiology centers. The study collects responses centrally to validate the simplified screening tool and to describe associations between identified sleep problems and cardiovascular conditions. Cardiologists also complete a brief impact survey to record whether the tool changes screening or referral behavior in routine practice.
Who should consider this trial
Good fit: Adults (≥18 years) seen in cardiology who can complete an online questionnaire and who are not currently receiving active treatment for a severe sleep disorder are ideal candidates.
Not a fit: Patients already on active treatment for severe sleep disorders (for example CPAP, oral appliance, treated narcolepsy, or pharmacologically treated chronic insomnia) or those unable to complete the questionnaire are unlikely to benefit from this screening tool.
Why it matters
Potential benefit: If successful, the tool could help cardiologists quickly spot untreated sleep disorders that contribute to heart disease and lead to earlier referrals or treatment.
How similar studies have performed: Other screening tools like STOP‑Bang and the Epworth Sleepiness Scale have shown moderate success detecting sleep apnea, but simplified questionnaires specifically validated for routine cardiology visits are less well established.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Carquefou, France and 1 other locations
- Dr Thierry Garban — Carquefou, France, France (Recruiting)
- CHU de Poitiers — Poitiers, France, France (Recruiting)
Study contacts
- Study coordinator: Dr Thierry Garban
- Email: cardiosom@sfcardio.fr
- Phone: 01 44 90 70 28
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.