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OpenTrials
Enrolling by Invitation

NCT Number: NCT07430878

Smart Devices-based Longitudinal Assessment of Patterns of Insomnia

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

Enrolling by Invitation

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Withings

Issy-les-Moulineaux, France

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Use of the Withings sleep-related devices

Device

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

questionnaires

Other

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

Primary outcomes

  1. insomnia presence/absence using a Questionnaire

    Time frame: From enrollment and for 26 weeks

  2. Severity of Insomnia using a Questionnaire

    Time frame: : From enrollment and for 26 weeks

Secondary outcomes

  1. The rate and duration of use the Withings device and the questionnaire answered

    Time frame: From enrollment and for 26 weeks

Sponsors and collaborators

Lead sponsor

Withings

Industry

Collaborators

  • INSERM Neurodiderot UMR 1141
  • Reykjavik University
  • Université Paris Cité

Registry information

Acronym: SLEEPI

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 24, 2026
Registry last updated
Mar 18, 2026

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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