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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06141967
Acronym
AMELIAS
Enrollment
600
Registered
2023-11-21
Start date
2023-11-30
Completion date
2025-07-09
Last updated
2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Metabolic Syndrome, Obese, Sleep Apnea Syndromes

Keywords

Sleep Apnea Syndromes, Diabetes, Withings Sleep analyzer, Epworth, Berlin

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.

Interventions

DEVICEWITHINGS 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.

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
patients real positive for each screening techniqueDay 2Percentage of patients real positive for each screening technique: BERLIN and EPWORTH score and Withings Sleep Analyzer addressed for polysomnography

Secondary

MeasureTime frameDescription
Patient's experience with the use of Withings Sleep AnalyzerDay 2Patients' experience is evaluated using a questionnaire with the following possible answers: yes a lot, yes a little, not at all.
Nurse's satisfaction with the use of Withings Sleep Analyzer3 monthsNurse's satisfaction is evaluated using a questionnaire with the following possible answers: yes a lot, yes a little, not at all.
Number of testsDay 2Number of positive tests / Number of analyzable test for screening for each type of test

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026