Is There a Desensitization During Sleep After Exposure to a Violent Verbal Input ?

NCT ID: NCT03074578

Last Updated: 2017-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-08

Study Completion Date

2017-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Verbal Abuse

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Watching two different videos (one violent, one non-violent), re-exposure after 11h daytime (wake period) or 11h nighttime (sleep period). The order of videos is balanced, in a cross over fashion
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
The analysis of heart signal, polysomnography and dream reports analysis will be performed by assessors masked to the group and type of video.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Night-time desensitization

Watching a video containing verbal and visual violence in the evening, and again in the next morning

Group Type EXPERIMENTAL

Watching Video-clip 1

Intervention Type BEHAVIORAL

Video -clip 1 contains violent images and text

Watching Video-clip 2

Intervention Type BEHAVIORAL

Video -clip 2 contains neutral images and text

Daytime desensitization

Watching a video containing verbal and visual non-violence in the morning, and then again the evening of the same day

Group Type SHAM_COMPARATOR

Watching Video-clip 1

Intervention Type BEHAVIORAL

Video -clip 1 contains violent images and text

Watching Video-clip 2

Intervention Type BEHAVIORAL

Video -clip 2 contains neutral images and text

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Watching Video-clip 1

Video -clip 1 contains violent images and text

Intervention Type BEHAVIORAL

Watching Video-clip 2

Video -clip 2 contains neutral images and text

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

Centre National de la Recherche Scientifique, France

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Isabelle Arnulf

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Isabelle Arnulf, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Pitie Salpêtrière Hospital, Paris, France

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Service des pathologies du sommeil, Hôpital Pitié Salpêtrière

Paris, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Isabelle Arnulf, MD, PhD

Role: CONTACT

(0)1 42 16 77 02 ext. +33

Béatrice Fracchiolla, PhD

Role: CONTACT

(0)387315832 ext. +33

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Beatrice Fracchiolla, PhD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

Barros A, Uguccioni G, Salkin-Goux V, Leu-Semenescu S, Dodet P, Arnulf I. Simple behavioral criteria for the diagnosis of disorders of arousal. J Clin Sleep Med. 2020 Jan 15;16(1):121-128. doi: 10.5664/jcsm.8136. Epub 2019 Dec 4.

Reference Type DERIVED
PMID: 31957639 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

COREV

Identifier Type: OTHER

Identifier Source: secondary_id

16009

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Social Experiences and Sleep Study
NCT03937973 COMPLETED NA
Exploring the Link Between Sleep and Brain Clearance
NCT05539378 ENROLLING_BY_INVITATION NA
Aging, Sleep, Cognitive Process
NCT00804804 COMPLETED NA
Sleep-dependent Learning in Aging
NCT03840083 RECRUITING NA
Intervention Study in Elderly With Sleep Problems
NCT05485415 ACTIVE_NOT_RECRUITING NA