Suicide, AttemptedSSLEEMNCT03068598
Suicide Sleep Monitoring (Ssleem)
A study testing PulseOn watch/Suunto Spartan Ultra watch in people with Suicide, Attempted, run by University Hospital, Brest at 1 site in France.
Trial summary
Promising results have shown that interventions to reduce insomnia diminish suicidal ideation. A better understanding of the bidirectional mechanism between sleep disturbances and suicide behavior will allow the design of tailored interventions to prevent suicide attempts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide, Attempted
- What is being tested?
- PulseOn watch/Suunto Spartan Ultra watch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteFrance
- Study dates
- 8 Mar 2017to 6 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female, aged 18 or older,
- with suicide attempt or suicidal ideas history,
- able to understand the study,
- insured persons,
- having signed a consent form.
Who cannot join
- minor patient,
- patient whose clinical status is incompatible with informed consent,
- patient tattooed on both wrists
- patient under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Connected Sleep Recording Device for Suicidal Patients, Acceptability Study - Suicide Sleep Monitoring (Ssleem)
Promising results have shown that interventions to reduce insomnia diminish suicidal ideation. A better understanding of the bidirectional mechanism between sleep disturbances and suicide behavior will allow the design of tailored interventions to prevent suicide attempts.
Significance of the proposed study for the field The aim of the present is to assess the feasibility and the acceptability of sleep tracking monitoring in a sample of suicide attempters. The investigator hypothesize that sleep monitoring using a connected object is feasable and acceptable by patients.
- Conditions
- Suicide, Attempted
- Being tested
- PulseOn watch/Suunto Spartan Ultra watch
- Medical subject headings
- Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PulseOn watch/Suunto Spartan Ultra watchDevice
The Watch (PulseOn or Suunto Spartan Ultra) and a smartphone will be given to the patient after discharge. After a brief training on how to use the sleep tracker, patient will monitor his sleep with watch during the five nights following the discharge. All data will be transmitted directly to the smartphone. Each morning, the patient will complete a questionnaire to assess the quality of his sleep and on day 5, during a standart follow up visit, he will complete a questionnaire evaluating the acceptability of the sleep recording device.
| Study group | Role | What they receive |
|---|---|---|
| sleep monitoring | Experimental | The sleep tracker and a smartphone will be given to the patient after discharge. The patient will recieve a brief training on how to use the PulseOn watch or the Suunto Spartan Ultra watch. Patient will be proposed to monitor his sleep during the five nights following the discharge. Receives: Device: PulseOn watch/Suunto Spartan Ultra watch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the sleep recorder device in patients with previous history of suicide attempts
Score obtained at the scale evaluating acceptability of the sleep recorder device during the study exit interview 5 days after inclusion
Measured: 5 days after discharge
Secondary outcomes (1)
Link between the connected record and the data collected using a self-administered questionnaire evaluating qualitatively and quantitatively sleep.
Subjective evaluation of sleep by a validated questionnaire compared to the data of the sleep recording.
Measured: 5 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start8 Mar 2017
- Primary completion6 Mar 2019
- Study completion6 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide, AttemptedStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The subject will receive a watch connected to a smartphone, wear at night and objectively evaluate sleep in ecological conditions
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068598
- Sponsor's protocol ID
- SSLEEM 29BRC16.0107
- Acronym
- SSLEEM
- Status last verified
- Jan 2018
- First submitted
- 22 Feb 2017
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connected Sleep Recording Device for Suicidal Patients, Acceptability Study - Suicide Sleep Monitoring (Ssleem)
- ClinicalTrials.gov ID
- NCT03068598
- Acronym / sponsor ID
- SSLEEM / SSLEEM 29BRC16.0107
- Conditions
- Suicide, Attempted
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 8 Mar 2017 (actual)
- Primary completion
- 6 Mar 2019 (actual)
- Study completion
- 6 Mar 2019 (actual)
- First posted
- 3 Mar 2017 (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.
Promising results have shown that interventions to reduce insomnia diminish suicidal ideation. A better understanding of the bidirectional mechanism between sleep disturbances and suicide behavior will allow the design of tailored interventions to prevent suicide attempts.
Significance of the proposed study for the field The aim of the present is to assess the feasibility and the acceptability of sleep tracking monitoring in a sample of suicide attempters. The investigator hypothesize that sleep monitoring using a connected object is feasable and acceptable by patients.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The subject will receive a watch connected to a smartphone, wear at night and objectively evaluate sleep in ecological conditions
| Arm | Type | Receives |
|---|---|---|
| sleep monitoring | Experimental | Device: PulseOn watch/Suunto Spartan Ultra watchThe sleep tracker and a smartphone will be given to the patient after discharge. The patient will recieve a brief training on how to use the PulseOn watch or the Suunto Spartan Ultra watch. Patient will be proposed to monitor his sleep during the five nights following the discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- male or female, aged 18 or older,
- with suicide attempt or suicidal ideas history,
- able to understand the study,
- insured persons,
- having signed a consent form.
Key exclusion criteria (4 listed)
- minor patient,
- patient whose clinical status is incompatible with informed consent,
- patient tattooed on both wrists
- patient under guardianship or curatorship
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 |
|---|---|---|
| PulseOn watch/Suunto Spartan Ultra watchThe Watch (PulseOn or Suunto Spartan Ultra) and a smartphone will be given to the patient after discharge. After a brief training on how to use the sleep tracker, patient will monitor his sleep with watch during the five nights following the discharge. All data will be transmitted directly to the smartphone. Each morning, the patient will complete a questionnaire to assess the quality of his sleep and on day 5, during a standart follow up visit, he will complete a questionnaire evaluating the acceptability of the sleep recording device. | Device | sleep monitoring |
Primary outcome
Acceptability of the sleep recorder device in patients with previous history of suicide attempts
Time frame: 5 days after discharge
Score obtained at the scale evaluating acceptability of the sleep recorder device during the study exit interview 5 days after inclusion
1 secondary outcome
Link between the connected record and the data collected using a self-administered questionnaire evaluating qualitatively and quantitatively sleep.
Time frame: 5 days after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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 PulseOn watch/Suunto Spartan Ultra watch in people with Suicide, Attempted, run by University Hospital, Brest 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 4 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: finished, as of the sponsor's last update on 7 Aug 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Acceptability of the sleep recorder device in patients with previous history of suicide attempts (time frame: 5 days after discharge). 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 7 Aug 2024; AzTrials last refreshed its copy on 7 Nov 2026.