Suicide Sleep Monitoring (Ssleem) (SSLEEM)
Primary Purpose
Suicide, Attempted
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PulseOn watch/Suunto Spartan Ultra watch
Sponsored by
About this trial
This is an interventional device feasibility trial for Suicide, Attempted
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- minor patient,
- patient whose clinical status is incompatible with informed consent,
- patient tattooed on both wrists
- patient under guardianship or curatorship
Sites / Locations
- CHRU de BrestRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
sleep monitoring
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03068598
First Posted
February 22, 2017
Last Updated
January 5, 2018
Sponsor
University Hospital, Brest
1. Study Identification
Unique Protocol Identification Number
NCT03068598
Brief Title
Suicide Sleep Monitoring (Ssleem)
Acronym
SSLEEM
Official Title
Connected Sleep Recording Device for Suicidal Patients, Acceptability Study - Suicide Sleep Monitoring (Ssleem)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 8, 2017 (Actual)
Primary Completion Date
June 13, 2018 (Anticipated)
Study Completion Date
July 13, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Attempted
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
sleep monitoring
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
PulseOn watch/Suunto Spartan Ultra watch
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acceptability of the sleep recorder device in patients with previous history of suicide attempts
Description
Score obtained at the scale evaluating acceptability of the sleep recorder device during the study exit interview 5 days after inclusion
Time Frame
5 days after discharge
Secondary Outcome Measure Information:
Title
Link between the connected record and the data collected using a self-administered questionnaire evaluating qualitatively and quantitatively sleep.
Description
Subjective evaluation of sleep by a validated questionnaire compared to the data of the sleep recording.
Time Frame
5 days after discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
minor patient,
patient whose clinical status is incompatible with informed consent,
patient tattooed on both wrists
patient under guardianship or curatorship
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sofian BERROUIGUET, Doctor
Email
sofian.berrouiguet@chu-brest.fr
Facility Information:
Facility Name
CHRU de Brest
City
Brest
ZIP/Postal Code
29609
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sofian BERROUIGUET, Dr
Email
sofian.berrouiguet@chu-brest.fr
First Name & Middle Initial & Last Name & Degree
Sofian BERROUIGUET, Dr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Suicide Sleep Monitoring (Ssleem)
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