Suicide Sleep Monitoring (Ssleem) (SSLEEM)

Connected Sleep Recording Device for Suicidal Patients, Acceptability Study - 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.

Study Overview

• Status: Completed
• Conditions: Suicide, Attempted
• Intervention / Treatment: Device: PulseOn watch/Suunto Spartan Ultra watch

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • CHRU de Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2017
• Primary Completion (Actual): March 6, 2019
• Study Completion (Actual): March 6, 2019

Study Registration Dates

• First Submitted: February 22, 2017
• First Submitted That Met QC Criteria: February 27, 2017
• First Posted (Actual): March 3, 2017

Study Record Updates

• Last Update Posted (Actual): August 7, 2024
• Last Update Submitted That Met QC Criteria: August 6, 2024
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicide, Attempted
• Other Study ID Numbers: SSLEEM 29BRC16.0107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No