Suicide Sleep Monitoring (Ssleem)

Suicide, Attempted Clinical Trial

— SSLEEM  

Official title:

Connected Sleep Recording Device for Suicidal Patients, Acceptability Study - Suicide Sleep Monitoring (Ssleem)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03068598
• Other study ID #: SSLEEM 29BRC16.0107
• Status: Recruiting
• Phase: N/A
• First received: February 22, 2017
• Last updated: January 5, 2018
• Start date: March 8, 2017
• Est. completion date: July 13, 2018

Study information

• Verified date: January 2018
• Source: University Hospital, Brest
• Contact: Sofian BERROUIGUET, Doctor
• Email: sofian.berrouiguet[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 13, 2018
• Est. primary completion date: June 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Suicide
• Suicide, Attempted

Intervention

Device:
• PulseOn watch/Suunto Spartan Ultra watch
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.

Locations

Country	Name	City	State
France	CHRU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	5 days after discharge