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Clinical Trials/NCT03793699
NCT03793699
Unknown
Not Applicable

Evaluation of the Links Between Sleep Disorders and the Risk of Suicide Attempt

University Hospital, Lille1 site in 1 country60 target enrollmentFebruary 4, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Attempted Suicide
Sponsor
University Hospital, Lille
Enrollment
60
Locations
1
Primary Endpoint
Sleep disorders intensity by the Insomnia Severity Index (ISI)
Last Updated
5 years ago

Overview

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

Detailed Description

Pilot, prospective, monocentric case-control study. There are 2 groups of subjects : * group of patients who have made a suicide attempt * control group with only suicidal ideas First visit V1 is performed within the first 72 hours of hospitalization. A re-assessment is scheduled 1 month after (V2). At V1, collected parameters are : chronic sleep disorders, chronotype, specific sleep disorders in posttraumatic stress disorder, nightmares and the distress associated, childhood trauma, cognitive dysfunction, suicidal ideation and psychopathologic assessment. At V2, we assess evolution of sleep disturbances and suicidal ideation.

Registry
clinicaltrials.gov
Start Date
February 4, 2019
End Date
December 2022
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Lille
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • 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)

Outcomes

Primary Outcomes

Sleep disorders intensity by the Insomnia Severity Index (ISI)

Time Frame: at the 48 hours after the hospitalization; at the maximum within 72 hours.

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.

Secondary Outcomes

  • 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.)
  • Montréal Cognitive Assessment (MocA)(at the 48 hours after the hospitalization; at the maximum within 72 hours.)

Study Sites (1)

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