Using a connected device to improve sleep apnea screening in hospitalized patients
Evaluating of the Impact of a Connected and Non-intrusive Device in Improving the Screening of Sleep Apnea Syndrome and the Addressing of Potentially Pathological Patients in Hospital Environment
This study is testing a new connected device to see if it can help doctors better screen hospitalized patients with diabetes, obesity, or metabolic syndrome for sleep apnea.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne Academic / other |
| Locations | 1 site (Saint-etienne) |
| Trial ID | NCT06141967 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a non-intrusive connected device, the Withings Sleep Analyzer, in enhancing the screening process for sleep apnea syndrome among hospitalized patients with diabetes, obesity, or metabolic syndrome. The focus is on addressing the under-referral of these patients for treatment, which is often due to organizational challenges in care delivery. By implementing a new care organization model, the study seeks to streamline the identification and management of potentially pathological patients. The study will involve adult patients who meet specific eligibility criteria and are hospitalized in the Endocrinology department.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with diabetes, obesity, or metabolic syndrome who are hospitalized for at least one night.
Not a fit: Patients with known and/or treated obstructive sleep apnea syndrome (OSAS) will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the identification and treatment of sleep apnea in at-risk hospitalized patients, leading to better health outcomes.
How similar studies have performed: While there is existing research on sleep apnea screening, this specific approach using a connected device in a hospital setting is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients over 18 years old * Diabetes Mellitus (Type 1 or 2), or obesity (BMI\>30kg/m²) or metabolic syndrome * Hospitalized for at least one night in the Endocrinology department * Affiliated or entitled to a social security scheme * Having received informed information about the study and having co-signed, with the investigator, the informed consent form for participation in the study Exclusion Criteria: * Known and/or treated OSAS-type respiratory pathology * No signature of the informed consent form * Minor or adult patients under guardianship or curatorship
Where this trial is running
Saint-etienne
- CHU de Saint-Etienne — Saint-etienne, France (Recruiting)
Study contacts
- Principal investigator: Natacha GERMAIN, MD-PhD — CHU de Saint-Etienne
- Study coordinator: Natacha GERMAIN, MD PhD
- Email: natacha.germain@chu-st-etienne.fr
- Phone: (0)477120621
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.