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 (AMELIAS)

Centre Hospitalier Universitaire de Saint Etienne

Status: Completed

Conditions: Obese; Sleep Apnea Syndromes; Diabetes; Metabolic Syndrome

Treatments: Device: WITHINGS Sleep Analyzer

Study type: Interventional

Funder types: Other

Identifiers

NCT06141967

ANSM (Other Identifier)

23CH133

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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600 participants in 1 patient group

WITHINGS Sleep Analyzer

Experimental group

Description:

The sleep apnea screening device used is a medical screening device WITHINGS Sleep Analyzer (WSA)

Treatment:

Device: WITHINGS Sleep Analyzer