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)

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.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea Syndromes; Diabetes; Metabolic Syndrome; Obese
• Intervention / Treatment: Device: WITHINGS Sleep Analyzer

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 Type: Interventional
• Enrollment (Actual): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-etienne, France, 42055
    • CHU de Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Device: WITHINGS Sleep Analyzer; Potentially 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.; Other Names: WSA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patients real positive for each screening technique	Percentage of patients real positive for each screening technique: BERLIN and EPWORTH score and Withings Sleep Analyzer addressed for polysomnography	Day 2

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Natacha GERMAIN, MD-PhD, CHU de Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2023
• Primary Completion (Actual): February 19, 2025
• Study Completion (Actual): July 9, 2025

Study Registration Dates

• First Submitted: November 9, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Actual): November 21, 2023

Study Record Updates

• Last Update Posted (Actual): July 18, 2025
• Last Update Submitted That Met QC Criteria: July 17, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Diabetes; Sleep Apnea Syndromes; Withings Sleep analyzer; Epworth; Berlin
• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Metabolic Diseases; Respiratory Tract Diseases; Disease; Respiration Disorders; Glucose Metabolism Disorders; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Insulin Resistance; Hyperinsulinism; Sleep Disorders, Intrinsic; Dyssomnias; Syndrome; Metabolic Syndrome; Sleep Apnea Syndromes; Apnea
• Other Study ID Numbers: 23CH133; ANSM (Other Identifier: 2025-A00293-46)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No