NCT01025310

Brief 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. 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:

  1. 1.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.
  2. 2.Heart rate pulse will be measured using a commercial pulse-meter.
  3. 3.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).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2009

Completed
1.3 years until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

October 14, 2015

Status Verified

November 1, 2012

Enrollment Period

8 months

First QC Date

December 2, 2009

Last Update Submit

October 12, 2015

Conditions

Keywords

eye movementssaccadesvisualstresssearch coilenvironmentSaccadic eye movementsUrban environment

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • Healthy subject
  • Normal vision

You may not qualify if:

  • Eye disease such as corneal or scleral abrasion or disease, glaucoma
  • Refractive errors greater than 2 diopters
  • Concurrent medication with CNS-active agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology

Kfar Saba, Kfar Saba, 44281, Israel

Location

Study Officials

  • Carlos R Gordon, MD, DSc

    Department of Neurology, Meir Medical Center, Kfar Saba, Israel

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2009

First Posted

December 3, 2009

Study Start

April 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2012

Last Updated

October 14, 2015

Record last verified: 2012-11

Locations