AMELIAS: 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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Recruiting

CT.gov ID

NCT06141967

Collaborator

(none)

600

Enrollment

Location

Arm

21.7

Anticipated Duration (Months)

27.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea Syndromes Metabolic Syndrome Diabetes Obese	Device: WITHINGS Sleep Analyzer	N/A

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. We would like to test a new organization of care to facilitate and intensify this screening.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Nov 9, 2023

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Number of tests [Day 2]
Number of positive tests / Number of analyzable test for screening for each type of test
Patient's experience with the use of Withings Sleep Analyzer [Day 2]
Patient's experience is evaluated by a scale : yes a lot, yes a little lot, not at all
Nurse's satisfaction with the use of Withings Sleep Analyzer [3 months]
Nurse's satisfaction is evaluated by a scale : yes a lot, yes a little lot, not at all

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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