Smart Devices-based Longitudinal Assessment of Patterns of Insomnia (SLEEPI)

March 16, 2026 updated by: Withings
The objective of the study is to develop an algorithm to detect insomnia and classify its severity, based on data collected during the use of Withings products and from questionnaires sent to users

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

17000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Issy-les-Moulineaux, France
        • Withings

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • is an adult(18 years old or more).
  • is affiliated or eligible to a social security system.
  • has expressed their consent to take part in the study.
  • owns any of the following Withings monitoring devices: ScanWatch, ScanWatch 2 or Sleep Analyzer.
  • has Withings mobile application with version greater or equal to 5.12.

Exclusion Criteria:

  • Minors under 18 years old.
  • Subjects having refused to give their consent.

  • Vulnerable subjects according to the country regulation in force:

    • Individuals deprived of liberty by a court, medical or administrative order,
    • Individuals legally protected or unable to express their consent to take part in the study,
    • Individuals unaffiliated to or not beneficiary of a social security system,
    • Individuals who fit in multiple categories above,
  • Individuals linguistically or mentally unable to express their consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: All participants who agreed to participate to the study and compliant to the inclusion criteria
The participants are asking to answer several questionnaires and to use their Withings sleep-related device(s) as much as possible
Device: Use of the Withings sleep-related devices
The participants are asking to use their Withings sleep-related device(s) as much as possible
Other: Questionnaires
The participant are asking to answer several questionnaires regarding their quality of sleep via Withings mobile application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
insomnia presence/absence using a Questionnaire
Time Frame: From enrollment and for 26 weeks
From enrollment and for 26 weeks
Severity of Insomnia using a Questionnaire
Time Frame: : From enrollment and for 26 weeks
: From enrollment and for 26 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The rate and duration of use the Withings device and the questionnaire answered
Time Frame: From enrollment and for 26 weeks
From enrollment and for 26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Withings

Collaborators

Reykjavik University
Université Paris Cité
INSERM Neurodiderot UMR 1141

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 17, 2027

Study Registration Dates

First Submitted

February 17, 2026

First Submitted That Met QC Criteria

February 17, 2026

First Posted (Actual)

February 24, 2026

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-A01028-39

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Insomnia

Clinical Trials on Use of the Withings sleep-related devices

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe