- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03074578
Is There a Desensitization During Sleep After Exposure to a Violent Verbal Input ? (COREV)
March 3, 2017 updated by: Isabelle Arnulf, Centre National de la Recherche Scientifique, France
Y a T-il Une désensibilisation Pendant le Sommeil après la réception de Violence Verbale ?
There is a need for quantify the emotional and neurophysiological perception of verbal violence, in order to understand the impact it might have on a subject.
This project aims at assessing the influence of time, sleep, and people interaction on the perception of verbal violence.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
There are many processes involved in the perception of verbal violence.
There is a need for quantified data to have a better understanding the physiological and neurological perception of verbal violence, in order to understand the impact it might have on a subject.
This project aims at assessing the influence of time, sleep, and people interaction on the perception of verbal violence.
The "cognitive replay" will also be assessed through dreams.
The investigators think that sleep plays a role in desensitization to negative emotions and to memory consolidation.
However, the role of sleep in verbal violence remains unknown.
Study Type
Interventional
Enrollment (Anticipated)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Paris, France, 75013
- Recruiting
- service des pathologies du sommeil, hôpital Pitié Salpêtrière
-
Contact:
- Beatrice Fracchiolla, PhD
- Email: beatrice.fracchiolla@univ-lorraine.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 25 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject fully understands French
- Subject willing to consent to the study and signed the written consent
- Subject is afiliated to the Freanch national health care system (Sécurité Sociale)
- Subject level of education superior to "Brevet des collèges" (an equivalent would be the general certificate of secondary education)
Exclusion Criteria:
- The subject is not able to understand the protocol
- The subject has a language disorder
- The subject has a psychiatric or neurological disorders
- The subject does not use psychotropic drugs
- The subject has watched the advertidement : "stop djihadisme", broadcasted on television by the french government
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Night-time desensitization
Watching a video containing verbal and visual violence in the evening, and again in the next morning
|
Video -clip 1 contains violent images and text
Video -clip 2 contains neutral images and text
|
|
SHAM_COMPARATOR: Daytime desensitization
Watching a video containing verbal and visual non-violence in the morning, and then again the evening of the same day
|
Video -clip 1 contains violent images and text
Video -clip 2 contains neutral images and text
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart rate
Time Frame: During each video exposure (duration 1.2 min), 4 times
|
heart rate in beat per min
|
During each video exposure (duration 1.2 min), 4 times
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sweating
Time Frame: During the video exposure (duration 1.2 min), 4 times
|
measure of electrodermal reaction, in millivolts
|
During the video exposure (duration 1.2 min), 4 times
|
|
Vasoconstriction
Time Frame: During the video exposure (duration 1.2 min), 4 times
|
measure of the pulse wave, in millivolts
|
During the video exposure (duration 1.2 min), 4 times
|
|
Emotions
Time Frame: Just after the video exposure, during 1 min
|
Analogic visual scales, in mm
|
Just after the video exposure, during 1 min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Isabelle Arnulf, MD, PhD, Pitie Salpêtrière Hospital, Paris, France
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 8, 2016
Primary Completion (ANTICIPATED)
July 1, 2017
Study Completion (ANTICIPATED)
July 1, 2017
Study Registration Dates
First Submitted
March 1, 2017
First Submitted That Met QC Criteria
March 3, 2017
First Posted (ACTUAL)
March 9, 2017
Study Record Updates
Last Update Posted (ACTUAL)
March 9, 2017
Last Update Submitted That Met QC Criteria
March 3, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16009
- COREV (OTHER: Centre d'Investigation Clinique Paris-Est)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.