Smart Devices-based Longitudinal Assessment of Patterns of Insomnia

NCT07430878 | Enrolling By Invitation

• 1 other identifier: 2024-A01028-39
• Study Type: interventional
• Target: 17,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Insomnia

Outcome Measures

Primary Outcomes (2)

• insomnia presence/absence using a Questionnaire

  From enrollment and for 26 weeks

• Severity of Insomnia using a Questionnaire

  : From enrollment and for 26 weeks

Secondary Outcomes (1)

• The rate and duration of use the Withings device and the questionnaire answered

  From enrollment and for 26 weeks

Study Arms (1)

All participants who agreed to participate to the study and compliant to the inclusion criteria

EXPERIMENTAL

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; Other: Questionnaires

Interventions

Use of the Withings sleep-related devices DEVICE

The participants are asking to use their Withings sleep-related device(s) as much as possible

All participants who agreed to participate to the study and compliant to the inclusion criteria

Questionnaires OTHER

The participant are asking to answer several questionnaires regarding their quality of sleep via Withings mobile application

All participants who agreed to participate to the study and compliant to the inclusion criteria

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Withings: lead
• INSERM Neurodiderot UMR 1141: collaborator
• Université Paris Cité: collaborator
• Reykjavik University: collaborator

Study Sites (1)

Withings

Issy-les-Moulineaux, France

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: February 24, 2026
• Study Start: February 18, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 17, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

FR (1)