Enrolling by invitation NCT07430878
Smart Devices-based Longitudinal Assessment of Patterns of Insomnia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Use of the Withings sleep-related devices, Questionnaires.
- Who it may be relevant to
- Registry conditions: Insomnia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- 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
Primary outcome measures
- insomnia presence/absence using a Questionnaire [Time frame: From enrollment and for 26 weeks]
- Severity of Insomnia using a Questionnaire [Time frame: : From enrollment and for 26 weeks]
Secondary outcome measures (1)
- The rate and duration of use the Withings device and the questionnaire answered [Time frame: From enrollment and for 26 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
France · 1 center
- Withings — Issy-les-Moulineaux
Identifiers
NCT: NCT07430878 · 2024-A01028-39