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

Not Applicable

Recruiting

• Conditions: Metabolic Syndrome; Diabetes; Sleep Apnea Syndromes; Obese
• Interventions: Device: WITHINGS Sleep Analyzer

• Registration Number: NCT06141967
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief 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.

Study Timeline

• Study First Submitted: 2023-11-09
• Study First Submitted QC: 2023-11-15
• Study First Posted: 2023-11-21
• Study Start: 2023-11-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-29
• Primary Completion: 2025-05
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
patients real positive for each screening technique	Day 2	Percentage of patients real positive for each screening technique: BERLIN and EPWORTH score and Withings Sleep Analyzer addressed for polysomnography

Secondary Outcome Measures

Name	Time	Method
Nurse's satisfaction with the use of Withings Sleep Analyzer	3 months	Nurse's satisfaction is evaluated using a questionnaire with the following possible answers: yes a lot, yes a little, not at all.
Patient's experience with the use of Withings Sleep Analyzer	Day 2	Patients' experience is evaluated using a questionnaire with the following possible answers: yes a lot, yes a little, not at all.
Number of tests	Day 2	Number of positive tests / Number of analyzable test for screening for each type of test

Trial Locations

Locations (1)

CHU de Saint-Etienne; 🇫🇷 Saint-etienne, France