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Completed

NCT Number: NCT03068598

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.

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Key information

Conditions

Suicide, Attempted Behavior Behavioral Symptoms Self-Injurious Behavior Suicide

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU de Brest

Brest, 29609, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    Subjective evaluation of sleep by a validated questionnaire compared to the data of the sleep recording.

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: SSLEEM

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 3, 2017
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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