InsomniaSLEEPINCT07430878
Smart Devices-based Longitudinal Assessment of Patterns of Insomnia
A study testing Use of the Withings sleep-related devices and Questionnaires in people with Insomnia, run by Withings at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- Use of the Withings sleep-related devices and Questionnaires
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17,000 participants
- Where
- 1 siteFrance
- Study dates
- 18 Feb 2025to 17 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- Use of the Withings sleep-related devices, Questionnaires
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of the Withings sleep-related devicesDevice
The participants are asking to use their Withings sleep-related device(s) as much as possible
QuestionnairesOther
The participant are asking to answer several questionnaires regarding their quality of sleep via Withings mobile application
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Use of the Withings sleep-related devices; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
insomnia presence/absence using a Questionnaire
Measured: From enrollment and for 26 weeks
Severity of Insomnia using a Questionnaire
Measured: : From enrollment and for 26 weeks
Secondary outcomes (1)
The rate and duration of use the Withings device and the questionnaire answered
Measured: From enrollment and for 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start18 Feb 2025
- Primary completionMay 2027 (estimated)
- Study completion17 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Withings
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- INSERM Neurodiderot UMR 1141, Université Paris Cité, Reykjavik University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430878
- Sponsor's protocol ID
- 2024-A01028-39
- Acronym
- SLEEPI
- Status last verified
- Mar 2026
- First submitted
- 17 Feb 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Devices-based Longitudinal Assessment of Patterns of Insomnia
- ClinicalTrials.gov ID
- NCT07430878
- Acronym / sponsor ID
- SLEEPI / 2024-A01028-39
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 17,000 participants (estimated)
- Lead sponsor
- WithingsIndustry (pharma, biotech, devices)
- Collaborators
- INSERM Neurodiderot UMR 1141, Université Paris Cité, Reykjavik University
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- 17 May 2027 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants who agreed to participate to the study and compliant to the inclusion criteria | Experimental | Device: Use of the Withings sleep-related devices, Other: QuestionnairesThe participants are asking to answer several questionnaires and to use their Withings sleep-related device(s) as much as possible |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- Minors under 18 years old.
- Subjects having refused to give their consent.
- Vulnerable subjects according to the country regulation in force:
- Individuals linguistically or mentally unable to express their consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of the Withings sleep-related devicesThe participants are asking to use their Withings sleep-related device(s) as much as possible | Device | All participants who agreed to participate to the study and compliant to the inclusion criteria |
| QuestionnairesThe participant are asking to answer several questionnaires regarding their quality of sleep via Withings mobile application | Other | All participants who agreed to participate to the study and compliant to the inclusion criteria |
Primary outcome
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
1 secondary outcome
The rate and duration of use the Withings device and the questionnaire answered
Time frame: From enrollment and for 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of the Withings sleep-related devices and Questionnaires in people with Insomnia, run by Withings at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
insomnia presence/absence using a Questionnaire (time frame: From enrollment and for 26 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.