NCT03793699

Brief Summary

Several studies have demonstrated an association between sleep disorders such as insomnia and nightmares to suicidal ideations and behaviors. Nevertheless, some of these studies are methodologically questionable especially in the exploration of sleep disorders. Furthermore, confounding factors such as depressive symptomatology are not controlled and the measurement of suicidal behavior has often been taken into account as a historical measure, not as a current event, which introduces uncertainties and a lack of precision regarding the temporality of the phenomena. Today, while the links between sleep disorders and suicidal risk are well known, we have a lack of information on the importance and the role of sleep disorders as a precipitating factor. Indeed, few studies have evaluated the temporal link between sleep disorders and suicidal acts. The objective of this study is to evaluate the links between acute and chronic sleep disorders and the risk of suicide attempt

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 4, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

February 4, 2019

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

September 11, 2020

Status Verified

September 1, 2020

Enrollment Period

3.8 years

First QC Date

October 16, 2018

Last Update Submit

September 10, 2020

Conditions

Keywords

SuicideSuicidal ideationSleep disorder

Outcome Measures

Primary Outcomes (1)

  • Sleep disorders intensity by the Insomnia Severity Index (ISI)

    ISI score in the last 2 weeks between a group of suicide attempts and a group with suicidal thoughts suicidal The Insomnia Severity Index has seven questions. The seven answers are added up to get a total score.

    at the 48 hours after the hospitalization; at the maximum within 72 hours.

Secondary Outcomes (6)

  • Correlation between Beck Suicide Intent Scale (BSIS) score and ISI score

    Baseline (visit inclusion) and at one month ago

  • Evolution of ISI score

    At one month +/- 15 days ant at 3 months +/-3 weeks

  • Chronotype classification by MCTQ

    at the 48 hours after the hospitalization; at the maximum within 72 hours;at 3 months +/-3 weeks

  • Pittsburg Sleep Quality Index (PSQI) score

    at the 48 hours after the hospitalization; at the maximum within 72 hours,at 3 months +/-3 weeks

  • Childhood Trauma Questionnaire (CTQ) score

    at the 48 hours after the hospitalization; at the maximum within 72 hours.

  • +1 more secondary outcomes

Study Arms (2)

case group : realized a suicide attempt

adults having realized a suicide attempt and without histories of suicide attempt.

control group : only suicidal ideas

adults having suicidal ideas without suicidal acting out and without histories of suicide attempt.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population in the study is a population of adults having realized a suicide attempt and without histories of suicide attempt. She(it) will be compared with a population of adults having suicidal ideas without suicidal acting out and without histories of suicide attempt.

You may qualify if:

  • Criterion specific to the studying group :
  • \- Subjects hospitalized and whose indication of hospitalization is a suicide attempt by voluntary drug intoxication or phlebotomy during the last 72 hours, without any history of attempted suicide
  • Criterion specific to the control group:
  • \- Subjects hospitalized since less than 72 hours, and whose indication of hospitalization is the presence of suicidal ideas, without any history of attempted suicide

You may not qualify if:

  • Pregnant of lactating women
  • Diagnosed dementia pathology
  • Proven intellectual disability
  • Patient whose physical or mental state does not allow the passing of the tests of the study
  • Under protective measures (guardianship/supervision)
  • Refusal to participate in the study
  • Diagnosed with chronic or severe psychiatric illness (psychotic disorder, bipolarity)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Fontan, CHU

Lille, France

RECRUITING

MeSH Terms

Conditions

Suicide, AttemptedSuicideSuicidal IdeationSleep Wake Disorders

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehaviorNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Vincent JARDON, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2018

First Posted

January 4, 2019

Study Start

February 4, 2019

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

September 11, 2020

Record last verified: 2020-09

Locations