Evaluation of the Links Between Sleep Disorders and the Risk of Suicide Attempt (NCT03793699) | Clinical Trial Compass
TerminatedNot Applicable
Evaluation of the Links Between Sleep Disorders and the Risk of Suicide Attempt
Stopped: sponsor decision COVID
France24 participantsStarted 2019-02-04
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sleep disorders intensity by the Insomnia Severity Index (ISI)
Timeframe: at the 48 hours after the hospitalization; at the maximum within 72 hours.