ClinicalTrials.gg
Enrolling by invitationNCT07430878SLEEPIUpdated Mar 18, 2026

Smart Devices-based Longitudinal Assessment of Patterns of Insomnia

An interventional study of Use of the Withings sleep-related devices and Questionnaires in Insomnia, sponsored by Withings. Enrolling by invitation at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-18.

Sponsored by Withings · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Feb 2025, registered Feb 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
17,000
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

03

In context

Sleep Initiation and Maintenance Disorders

2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.

This study's planned enrollment of 17,000 is above the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.

Browse Sleep Initiation and Maintenance Disorders studies →

Lead sponsor

Withings is the lead sponsor of 23 studies on the registry; 3 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
17,000 participants (estimated)

Study arms

  • 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 · Other: Questionnaires

Interventions

  • DeviceUse of the Withings sleep-related devices

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

  • OtherQuestionnaires

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

06

What researchers measure

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

07

Study locations

1 site
  • Withings
    Issy-les-Moulineaux, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07430878
Lead sponsor
Withings
Collaborators
INSERM Neurodiderot UMR 1141, Université Paris Cité, Reykjavik University
Responsible party
Sponsor
First posted
Feb 24, 2026
Start date
Feb 18, 2025
Primary completion
May 2027 (estimated)
Completion
May 17, 2027 (estimated)
Last update
Mar 18, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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