Verbal AbuseCOREVNCT03074578
Is There a Desensitization During Sleep After Exposure to a Violent Verbal Input ?
A study testing Watching Video-clip 1 and Watching Video-clip 2 in people with Verbal Abuse, run by Centre National de la Recherche Scientifique, France at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Verbal Abuse
- What is being tested?
- Watching Video-clip 1 and Watching Video-clip 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 8 Nov 2016to 1 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service des pathologies du sommeil, Hôpital Pitié Salpêtrière
Paris, 75013
Beatrice Fracchiolla, PhD, beatrice.fracchiolla@univ-lorraine.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Verbal Abuse
- Being tested
- Watching Video-clip 1, Watching Video-clip 2
- Keywords
- sleep, verbal abuse, polysomnography, perception, neuropsychological tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Watching Video-clip 1Behavioural
Video -clip 1 contains violent images and text
Watching Video-clip 2Behavioural
Video -clip 2 contains neutral images and text
| Study group | Role | What they receive |
|---|---|---|
| Night-time desensitization | Experimental | Watching a video containing verbal and visual violence in the evening, and again in the next morning Receives: Behavioral: Watching Video-clip 1; Behavioral: Watching Video-clip 2 |
| Daytime desensitization | Sham comparator | Watching a video containing verbal and visual non-violence in the morning, and then again the evening of the same day Receives: Behavioral: Watching Video-clip 1; Behavioral: Watching Video-clip 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
heart rate in beat per min
Measured: During each video exposure (duration 1.2 min), 4 times
Secondary outcomes (3)
Sweating
measure of electrodermal reaction, in millivolts
Measured: During the video exposure (duration 1.2 min), 4 times
Vasoconstriction
measure of the pulse wave, in millivolts
Measured: During the video exposure (duration 1.2 min), 4 times
Emotions
Analogic visual scales, in mm
Measured: Just after the video exposure, during 1 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start8 Nov 2016
- Primary completion1 Jul 2017 (estimated)
- Study completion1 Jul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Verbal AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre National de la Recherche Scientifique, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabelle Arnulf, Centre National de la Recherche Scientifique, France
- Investigators
- Isabelle Arnulf, MD, PhD, Principal investigator, Pitie Salpêtrière Hospital, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074578
- Sponsor's protocol ID
- 16009
- Other IDs
- COREV
- Acronym
- COREV
- Status last verified
- Mar 2017
- First submitted
- 1 Mar 2017
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31957639
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Y a T-il Une désensibilisation Pendant le Sommeil après la réception de Violence Verbale ?
- ClinicalTrials.gov ID
- NCT03074578
- Acronym / sponsor ID
- COREV / 16009
- Conditions
- Verbal Abuse
- Keywords
- sleep, verbal abuse, polysomnography, perception, neuropsychological tests
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Centre National de la Recherche Scientifique, FranceUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 8 Nov 2016 (actual)
- Primary completion
- 1 Jul 2017 (estimated)
- Study completion
- 1 Jul 2017 (estimated)
- First posted
- 9 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Night-time desensitization | Experimental | Behavioral: Watching Video-clip 1, Behavioral: Watching Video-clip 2Watching a video containing verbal and visual violence in the evening, and again in the next morning |
| Daytime desensitization | Sham comparator | Behavioral: Watching Video-clip 1, Behavioral: Watching Video-clip 2Watching a video containing verbal and visual non-violence in the morning, and then again the evening of the same day |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Watching Video-clip 1Video -clip 1 contains violent images and text | Behavioural | Daytime desensitization, Night-time desensitization |
| Watching Video-clip 2Video -clip 2 contains neutral images and text | Behavioural | Daytime desensitization, Night-time desensitization |
Primary outcome
Heart rate
Time frame: During each video exposure (duration 1.2 min), 4 times
heart rate in beat per min
3 secondary outcomes
Sweating
Time frame: During the video exposure (duration 1.2 min), 4 times
Vasoconstriction
Time frame: During the video exposure (duration 1.2 min), 4 times
Emotions
Time frame: Just after the video exposure, during 1 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- Derived from this study: PubMed 31957639Barros 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.
- Individual participant dataSharing planned: No
Related trials for Verbal Abuse
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Recruiting
Evaluation of the Efficacy of "Lifespan Integration" (LI) Therapy in Patients With Complex Post-Traumatic Stress Disorder
Post-Traumatic Stress Disorder Complex, Psychiatric Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Arnulf, MD, PhD principal investigator
Pitie Salpêtrière Hospital, Paris, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Watching Video-clip 1 and Watching Video-clip 2 in people with Verbal Abuse, run by Centre National de la Recherche Scientifique, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabelle Arnulf, MD, PhD ((0)1 42 16 77 02 ext. +33, isabelle.arnulf@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (time frame: During each video exposure (duration 1.2 min), 4 times). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03074578, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2017.