Clinical Trials Directory

Trials / Completed

CompletedNCT06141967

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
600 (actual)
Sponsor
Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Diabetes, obesity and metabolic syndrome are closely linked to sleep apnea syndrome. Indeed, diabetic and/or obese patients present an increased risk of sleep apnoea syndrome (SAS), with a prevalence estimated at between 10 and 22%, depending on the study, and most of them requiring treatment with Continuous Positive Airway Pressure (CPAP). In this sub-population of patients, only between 40% and 50% benefit from CPAP.

Detailed description

There is therefore an under-referral of diabetic patients to treatment, perhaps linked to the way care is organized, which clogs up the circuit and slows down or even prevents access to care. The investigators would like to test a new organization of care to facilitate and intensify this screening.

Conditions

Interventions

TypeNameDescription
DEVICEWITHINGS Sleep AnalyzerPotentially eligible patients will be offered to participate in the study, the information leaflet will be given to them and the informed consent form will be signed if the patient agrees to participate in the study. In hospitalization in Endocrinology: * Realization of the current care report * Including systematic achievement of EPWORTH and BERLIN scores * Activation of the WSA throughout the duration of the hospitalization * Completion of a feasibility questionnaire for the team * Quantification of the non-usable screening technique * Completion of a patient experience questionnaire at the end of the stay * In the event of published positive criteria either for the BERLIN questionnaires, EPWORTH questionnaires or WSA, the patient will be referred to the VISAS center for definitive diagnostic evaluation by polygraphy or polysomnography.

Timeline

Start date
2023-11-30
Primary completion
2025-02-19
Completion
2025-07-09
First posted
2023-11-21
Last updated
2025-07-18

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT06141967. Inclusion in this directory is not an endorsement.