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

Attempted Suicide Clinical Trial

— HYPNOS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03793699
• Other study ID #: 2017_55
• Secondary ID: 2017-A03649-44
• Status: Recruiting
• Start date: February 4, 2019
• Est. completion date: December 2022

Study information

• Verified date: September 2020
• Source: University Hospital, Lille
• Contact: Vincent JARDON, MD
• Phone: 320 44 45 84
• Email: vincent.jardon[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Attempted Suicide
• Parasomnias
• Sleep Wake Disorders
• Suicide
• Suicide, Attempted

Locations

Country	Name	City	State
France	Hôpital Fontan, CHU	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Correlation between Beck Suicide Intent Scale (BSIS) score and ISI score	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	Baseline (visit inclusion) and at one month ago
Secondary	Evolution of ISI score	Assess the evolution of sleep disturbances for each group by ISI Score	At one month +/- 15 days ant at 3 months +/-3 weeks
Secondary	Chronotype classification by MCTQ	Exploratory descriptive measures in the 2 groups	at the 48 hours after the hospitalization; at the maximum within 72 hours;at 3 months +/-3 weeks
Secondary	Pittsburg Sleep Quality Index (PSQI) score	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.	at the 48 hours after the hospitalization; at the maximum within 72 hours,at 3 months +/-3 weeks
Secondary	Childhood Trauma Questionnaire (CTQ) score	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.	at the 48 hours after the hospitalization; at the maximum within 72 hours.
Secondary	Montréal Cognitive Assessment (MocA)	cognitive assessment by Moca test	at the 48 hours after the hospitalization; at the maximum within 72 hours.