- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03793699
Evaluation of the Links Between Sleep Disorders and the Risk of Suicide Attempt (HYPNOS)
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
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Vincent JARDON, MD
- Phone Number: +33 320 44 45 84
- Email: vincent.jardon@chru-lille.fr
Study Locations
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Lille, France
- Recruiting
- Hôpital Fontan, CHU
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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case group : realized a suicide attempt
adults having realized a suicide attempt and without histories of suicide attempt.
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control group : only suicidal ideas
adults having suicidal ideas without suicidal acting out and without histories of suicide attempt.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep disorders intensity by the Insomnia Severity Index (ISI)
Time Frame: at the 48 hours after the hospitalization; at the maximum within 72 hours.
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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.
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at the 48 hours after the hospitalization; at the maximum within 72 hours.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between Beck Suicide Intent Scale (BSIS) score and ISI score
Time Frame: Baseline (visit inclusion) and at one month ago
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Correlation between Beck Suicide Intent Scale (BSIS) score and ISI score The Suicide Intent Scale (SIS) wconsists of 15 questions which are scaled from 0-2, which take into account both the logistics of the suicide attempt as well as the intent.
The scale has high reliability and validity.
Completed suicides ranked higher in the severity of the logistics than attempted suicides (it was impossible to measure intent for the completed suicides), and those with multiple attempts had higher scores than those who only attempted suicide once
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Baseline (visit inclusion) and at one month ago
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Evolution of ISI score
Time Frame: At one month +/- 15 days ant at 3 months +/-3 weeks
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Assess the evolution of sleep disturbances for each group by ISI Score
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At one month +/- 15 days ant at 3 months +/-3 weeks
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Chronotype classification by MCTQ
Time Frame: at the 48 hours after the hospitalization; at the maximum within 72 hours;at 3 months +/-3 weeks
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Exploratory descriptive measures in the 2 groups
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at the 48 hours after the hospitalization; at the maximum within 72 hours;at 3 months +/-3 weeks
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Pittsburg Sleep Quality Index (PSQI) score
Time Frame: at the 48 hours after the hospitalization; at the maximum within 72 hours,at 3 months +/-3 weeks
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PSQI score between the groups PSQI is a self-report questionnaire that assesses sleep quality over a 1-month time interval.
The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete.
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at the 48 hours after the hospitalization; at the maximum within 72 hours,at 3 months +/-3 weeks
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Childhood Trauma Questionnaire (CTQ) score
Time Frame: at the 48 hours after the hospitalization; at the maximum within 72 hours.
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CTQ score between the groups The Childhood Trauma Questionnaire was developed as a screening tool for histories of abut and neglect.
The self-report includes a 28-item test that measures 5 types of maltreatment - emotional, physical, and sexual abuse, and emotional and physical neglect.
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at the 48 hours after the hospitalization; at the maximum within 72 hours.
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Montréal Cognitive Assessment (MocA)
Time Frame: at the 48 hours after the hospitalization; at the maximum within 72 hours.
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cognitive assessment by Moca test
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at the 48 hours after the hospitalization; at the maximum within 72 hours.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017_55
- 2017-A03649-44 (OTHER: ID-RCB number, ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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