Clinical trial NCT03793699: Evaluation of the Links Between Sleep Disorders and the Risk of Suicide Attempt
Official title: Evaluation of the Links Between Sleep Disorders and the Risk of Suicide Attempt
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Attempted Suicide
Keywords: Suicide
Suicidal ideation
Sleep disorder
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2019-01-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.

Eligibility criteria: Inclusion Criteria

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

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)

Primary outcomes:
measure: Sleep disorders intensity by the Insomnia Severity Index (ISI)
timeFrame: at the 48 hours after the hospitalization; at the maximum within 72 hours.
Secondary outcomes:
measure: Correlation between Beck Suicide Intent Scale (BSIS) score and ISI score
timeFrame: Baseline (visit inclusion) and at one month ago
measure: Evolution of ISI score
timeFrame: At one month +/- 15 days ant at 3 months +/-3 weeks
measure: Chronotype classification by MCTQ
timeFrame: at the 48 hours after the hospitalization; at the maximum within 72 hours;at 3 months +/-3 weeks
measure: Pittsburg Sleep Quality Index (PSQI) score
timeFrame: at the 48 hours after the hospitalization; at the maximum within 72 hours,at 3 months +/-3 weeks
measure: Childhood Trauma Questionnaire (CTQ) score
timeFrame: at the 48 hours after the hospitalization; at the maximum within 72 hours.
measure: Montréal Cognitive Assessment (MocA)
timeFrame: at the 48 hours after the hospitalization; at the maximum within 72 hours.
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Fontan, CHU
Study officials:
affiliation: University Hospital, Lille
name: Vincent JARDON, MD
role: PRINCIPAL_INVESTIGATOR
References: