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Completed

NCT Number: NCT06141967

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, 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.

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Key information

Conditions

Sleep Apnea Syndromes Apnea Body Weight Diabetes Diabetes Mellitus Dyssomnias Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obese Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Saint-Etienne

Saint-Etienne, 42055, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WITHINGS Sleep Analyzer

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.

Other names: WSA

Primary outcomes

  1. patients real positive for each screening technique

    Time frame: Day 2

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

Secondary outcomes

  1. Number of tests

    Time frame: Day 2

    Number of positive tests / Number of analyzable test for screening for each type of test

  2. Patient's experience with the use of Withings Sleep Analyzer

    Time frame: Day 2

    Patients' experience is evaluated using a questionnaire with the following possible answers: yes a lot, yes a little, not at all.

  3. Nurse's satisfaction with the use of Withings Sleep Analyzer

    Time frame: 3 months

    Nurse's satisfaction is evaluated using a questionnaire with the following possible answers: yes a lot, yes a little, not at all.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: AMELIAS

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 21, 2023
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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