Suicide Sleep Monitoring (Ssleem)

NCT ID: NCT03068598

Last Updated: 2024-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-08

Study Completion Date

2019-03-06

Brief Summary

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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.

Detailed Description

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Conditions

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Suicide, Attempted

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The subject will receive a watch connected to a smartphone, wear at night and objectively evaluate sleep in ecological conditions
Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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sleep monitoring

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.

Group Type EXPERIMENTAL

PulseOn watch/Suunto Spartan Ultra watch

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHRU de Brest

Brest, , France

Site Status

Countries

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France

Other Identifiers

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SSLEEM 29BRC16.0107

Identifier Type: -

Identifier Source: org_study_id

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