Suicide Sleep Monitoring (Ssleem)

NCT03068598 | Completed

• 1 other identifier: SSLEEM 29BRC16.0107
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicide, Attempted

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  5 days after discharge

Study Arms (1)

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.

Device: PulseOn watch/Suunto Spartan Ultra watch

Interventions

PulseOn watch/Suunto Spartan Ultra watch DEVICE

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.

sleep monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• minor patient,
• patient whose clinical status is incompatible with informed consent,
• patient tattooed on both wrists
• patient under guardianship or curatorship

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHRU de Brest

Brest, 29609, France

Location

MeSH Terms

Conditions

Suicide, Attempted

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The subject will receive a watch connected to a smartphone, wear at night and objectively evaluate sleep in ecological conditions

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: March 3, 2017
• Study Start: March 8, 2017
• Primary Completion: March 6, 2019
• Study Completion: March 6, 2019
• Last Updated: August 7, 2024

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)