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

Diabetes Clinical Trial

— AMELIAS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06141967
• Other study ID #: 23CH133
• Secondary ID: ANSM
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2023
• Est. completion date: September 2025

Study information

• Verified date: November 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Natacha GERMAIN, MD PhD
• Phone: (0)477120621
• Email: natacha.germain[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: September 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Diabetes
• Metabolic Syndrome
• Obese
• Sleep Apnea Syndromes
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Saint-Etienne	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of tests	Number of positive tests / Number of analyzable test for screening for each type of test	Day 2
Secondary	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
Secondary	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