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

NCT ID: NCT06141967

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-30
• Study Completion Date: 2025-07-09

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.

Conditions

Sleep Apnea Syndromes; Metabolic Syndrome; Diabetes; Obese

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

WITHINGS Sleep Analyzer

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

Group Type: EXPERIMENTAL

WITHINGS Sleep Analyzer

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

WSA

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Natacha GERMAIN, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

CHU de Saint-Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

ANSM

Identifier Type: OTHER

Identifier Source: secondary_id

23CH133

Identifier Type: -

Identifier Source: org_study_id