SSLEEM: Suicide Sleep Monitoring (Ssleem)

Sponsor

University Hospital, Brest (Other)

Overall Status

Unknown status

CT.gov ID

NCT03068598

Collaborator

(none)

Enrollment

Location

Arm

16.2

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Suicide, Attempted	Device: PulseOn watch/Suunto Spartan Ultra watch	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Device Feasibility

Official Title:

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

Actual Study Start Date :

Mar 8, 2017

Anticipated Primary Completion Date :

Jun 13, 2018

Anticipated Study Completion Date :

Jul 13, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Acceptability of the sleep recorder device in patients with previous history of suicide attempts [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 Outcome Measures

Link between the connected record and the data collected using a self-administered questionnaire evaluating qualitatively and quantitatively sleep. [5 days after discharge]
Subjective evaluation of sleep by a validated questionnaire compared to the data of the sleep recording.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHRU de Brest	Brest		France	29609

Sponsors and Collaborators

University Hospital, Brest

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Brest

ClinicalTrials.gov Identifier:

NCT03068598

Other Study ID Numbers:

SSLEEM 29BRC16.0107

First Posted:

Mar 3, 2017

Last Update Posted:

Jan 9, 2018

Last Verified:

Jan 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Suicide

Suicide, Attempted

Study Results

No Results Posted as of Jan 9, 2018