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Smart Devices-based Longitudinal Assessment of Patterns of Insomnia

Smart Devices-based Longitudinal Assessment of Patterns of Insomnia

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07430878
Acronym
SLEEPI
Enrollment
17000
Registered
2026-02-24
Start date
2025-02-18
Completion date
2027-05-17
Last updated
2026-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

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

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

Sponsors

Withings
Lead SponsorINDUSTRY
INSERM Neurodiderot UMR 1141
CollaboratorUNKNOWN
Université Paris Cité
CollaboratorOTHER
Reykjavik University
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
insomnia presence/absence using a QuestionnaireFrom enrollment and for 26 weeks
Severity of Insomnia using a Questionnaire: From enrollment and for 26 weeks

Secondary

MeasureTime frame
The rate and duration of use the Withings device and the questionnaire answeredFrom enrollment and for 26 weeks

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026