Visual StressNCT01025310
Visual Stress of the Open Urban Environment
An observational study of Visual Stress, run by Meir Medical Center at 1 site in Israel.
Trial summary
Background and objectives: There is a general agreement that some types of urban environment could be the source of psychological stress as opposed to natural-relaxing environment. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Stress
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2011to Dec 2012
- Phase
- Observational
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy subjects aged 18-60 years old will be recruited for the study from students, faculty and staff of Tel Aviv University and of Meir Medical Center
Who may be able to join
- Healthy subject
- Normal vision
Who cannot join
- Eye disease such as corneal or scleral abrasion or disease, glaucoma
- Refractive errors greater than 2 diopters
- Concurrent medication with CNS-active agents
Trial locations and contacts
1 site in 1 country.
About this study
Background and objectives: There is a general agreement that some types of urban environment could be the source of psychological stress as opposed to natural-relaxing environment. A number of aesthetical researches found out that the main cause for stress appearance can be explained by the complexity and order of the environment. There are also some indications that the stressing influence of the open environment can be measured by evaluating eye movements, in particular saccadic movements.
The objective of this study is to characterize eye movements - mainly saccades -while presenting visual material of different complexity and order and to evaluate the possible relationship between eye movements and parameters of psychological and physiological stress.
Read more
Methods: The research is based on systematic gradual experiments on healthy volunteers, who will be tested while viewing series of abstract figures and pictures of natural and urban areas with different level of complexity and order. Each figure or picture will be showed to subjects for 7 seconds. During the whole experimental session the investigators will measure:
- Saccadic and other eye movements using the magnetic scleral search coil technique. The magnetic scleral search coil technique is the most sensitive and accurate technique used in modern ocular motor research for measuring horizontal, vertical and torsional eye movements. The coils are easy to apply and well tolerated over a wearing period of up to 45 minutes per recording session.
- Heart rate pulse will be measured using a commercial pulse-meter.
- Aesthetical evaluation: Following each figure or picture 7 seconds presentation; subjects will rate it in a scale from 1 (very relaxing) to 10 (very stressful).
Possible relationship between saccadic eye movements, heart rate and aesthetical rate will be analyzed using WIN 11 SPSS and MATLAB in statistically accepted ways.
Population: A total of about 60 healthy subjects aged 18-60 years old will be recruited for the study from students, faculty and staff of Tel Aviv University and of Meir Medical Center.
Criteria for inclusion: Healthy subject with normal vision
Criteria for exclusion: Eye disease such as corneal or scleral abrasion or disease, glaucoma, refractive errors greater than 2 diopters and concurrent medication with CNS-active agents.
- Conditions
- Visual Stress
- Keywords
- eye movements, saccades, visual, stress, search coil, environment, Saccadic eye movements, Urban environment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study startApr 2011
- Primary completionDec 2011
- Study completionDec 2012 (estimated)
Why it stopped: Administartive and technical problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual StressStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Tel Aviv University
- Responsible party
- Sponsor
- Investigators
- Carlos R Gordon, MD, DSc, Principal investigator, Department of Neurology, Meir Medical Center, Kfar Saba, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01025310
- Sponsor's protocol ID
- 107-09
- Status last verified
- Nov 2012
- First submitted
- 2 Dec 2009
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Stress of the Open Urban Environment
- ClinicalTrials.gov ID
- NCT01025310
- Acronym / sponsor ID
- 107-09
- Conditions
- Visual Stress
- Keywords
- eye movements, saccades, visual, stress, search coil, environment, Saccadic eye movements, Urban environment
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Administartive and technical problems
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Collaborators
- Tel Aviv University
- Study start
- Apr 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2012 (estimated)
- First posted
- 3 Dec 2009 (estimated)
- 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.
Background and objectives: There is a general agreement that some types of urban environment could be the source of psychological stress as opposed to natural-relaxing environment. A number of aesthetical researches found out that the main cause for stress appearance can be explained by the complexity and order of the environment. There are also some indications that the stressing influence of the open environment can be measured by evaluating eye movements, in particular saccadic movements.
The objective of this study is to characterize eye movements - mainly saccades -while presenting visual material of different complexity and order and to evaluate the possible relationship between eye movements and parameters of psychological and physiological stress.
Methods: The research is based on systematic gradual experiments on healthy volunteers, who will be tested while viewing series of abstract figures and pictures of natural and urban areas with different level of complexity and order. Each figure or picture will be showed to subjects for 7 seconds. During the whole experimental session the investigators will measure:
- Saccadic and other eye movements using the magnetic scleral search coil technique. The magnetic scleral search coil technique is the most sensitive and accurate technique used in modern ocular motor research for measuring horizontal, vertical and torsional eye movements. The coils are easy to apply and well tolerated over a wearing period of up to 45 minutes per recording session.
- Heart rate pulse will be measured using a commercial pulse-meter.
- Aesthetical evaluation: Following each figure or picture 7 seconds presentation; subjects will rate it in a scale from 1 (very relaxing) to 10 (very stressful).
Possible relationship between saccadic eye movements, heart rate and aesthetical rate will be analyzed using WIN 11 SPSS and MATLAB in statistically accepted ways.
Population: A total of about 60 healthy subjects aged 18-60 years old will be recruited for the study from students, faculty and staff of Tel Aviv University and of Meir Medical Center.
Criteria for inclusion: Healthy subject with normal vision
Criteria for exclusion: Eye disease such as corneal or scleral abrasion or disease, glaucoma, refractive errors greater than 2 diopters and concurrent medication with CNS-active agents.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy subjects aged 18-60 years old will be recruited for the study from students, faculty and staff of Tel Aviv University and of Meir Medical Center
Key inclusion criteria (2 listed)
- Healthy subject
- Normal vision
Key exclusion criteria (3 listed)
- Eye disease such as corneal or scleral abrasion or disease, glaucoma
- Refractive errors greater than 2 diopters
- Concurrent medication with CNS-active agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
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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.
Carlos R Gordon, MD, DSc principal investigator
Department of Neurology, Meir Medical Center, Kfar Saba, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Visual Stress, run by Meir Medical Center at 1 site in Israel.
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 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 14 Oct 2015. 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 Israel. 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 14 Oct 2015.