NCT06141967

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 21, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

November 30, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2025

Completed
Last Updated

July 18, 2025

Status Verified

July 1, 2025

Enrollment Period

1.2 years

First QC Date

November 9, 2023

Last Update Submit

July 17, 2025

Conditions

Sleep Apnea SyndromesMetabolic SyndromeDiabetesObese

Keywords

Sleep Apnea SyndromesDiabetesWithings Sleep analyzerEpworthBerlin

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Number of tests

    Day 2

  • Patient's experience with the use of Withings Sleep Analyzer

    Day 2

  • Nurse's satisfaction with the use of Withings Sleep Analyzer

    3 months

Study Arms (1)

WITHINGS Sleep Analyzer

EXPERIMENTAL

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

Device: WITHINGS Sleep Analyzer

Interventions

WITHINGS Sleep AnalyzerDEVICE

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.

Also known as: WSA
WITHINGS Sleep Analyzer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Known and/or treated OSAS-type respiratory pathology
  • No signature of the informed consent form
  • Minor or adult patients under guardianship or curatorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Sleep Apnea SyndromesMetabolic SyndromeDiabetes MellitusObesity

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Natacha GERMAIN, MD-PhD

    CHU de Saint-Etienne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2023

First Posted

November 21, 2023

Study Start

November 30, 2023

Primary Completion

February 19, 2025

Study Completion

July 9, 2025

Last Updated

July 18, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)