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BlindnessNCT00262509

Emergency Egress and Information System for Persons With Vision Loss

A study testing Egress Badge in people with Blindness, run by US Department of Veterans Affairs at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of the research project is to develop and evaluate an emergency egress system for persons with visual impairment, which would use existing lighted exit signage to provide egress information at a distance of up to 100 feet. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Blindness
What is being tested?
Egress Badge
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteUnited States
Study dates
Sep 2008to Apr 2009
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Must Be Blind with no better vision than light perception
  • Must be able to walk the necessary distances, i.e., three hours of intermittent indoor walking
  • OMCT (Orientation-Memory Concentration Test) of 10 or less

Who cannot join

  • Patients currently being treated at Atlanta VA Medical Center

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Atlanta VA Medical and Rehab Center, Decatur

    Decatur, Georgia, 30033

Other trials in United States

About this study

The purpose of the research project is to develop and evaluate an emergency egress system for persons with visual impairment, which would use existing lighted exit signage to provide egress information at a distance of up to 100 feet.

Read the detailed description

The purpose of the proposed three-year research project is to develop and evaluate an emergency egress system for persons with visual impairment. This system would use existing lighted exit signage to provide egress information at a distance of up to 100 feet. The distance is the same as the required visibility distance of lighted exit signs for sighted persons. By offering egress information at an equivalent distance, the investigators hypothesize that people with visual impairment can approach the egress performance of sighted persons.

The information transmitted will be equivalent to what a sighted person obtains, namely, the direction of the exit door. In addition, a description of the exit route will be provided including the distance to the exit door; lighting conditions, hazards and obstacles that will be encountered on the exit route; the distance down to the street; and where on the street they will be when they get out of the building. A receiver worn by the person will include a tiny optical array to sense the direction of each exit sign. The receiver will also translate the transmitted signal into a spoken message. A low-profile stereo bone conduction headset will indicate the direction to each exit sign along a path to the exit door. For people with some hearing loss, this same low-profile headset will be used to simulate a light "tap" to one side or other of the head to indicate direction. Such directional "tapping" output may also prove effective when loud alarms are blaring.

The objectives are to:

  1. develop Talking Exit Lights with a range of at least 100 feet,
  2. write software for the user device to accurately indicate the direction of Talking Exit Lights and provide spoken messages,
  3. optimize the user interface to make it easy and intuitive to use,
  4. test the accuracy and reliability of the developed system in terms of transmission range and directional accuracy, and
  5. conduct subject evaluations of the new system.

Two versions of transmitting exit signs will be developed:

  1. a retro-fit design for existing fluorescent light exit signs, and
  2. a Light Emitting Diode (LED) design for the LED exit signs now going into newly constructed buildings.

For the retro-fit version, Talking Lights, LLC, will modify the physical shape and size of their Talking Light digital ballast, making it a fully compatible replacement for existing exit sign ballasts. VA investigators will develop the LED version, designing and constructing a microprocessor-controlled system for storing and transmitting information using LEDs. Both designs will use secure power line communications to upload transmittal information to specific exit signs, each of which will have its own ID number. Finally, VA investigators will write software for the existing Talking Lights PocketPC receiver to interpret sensor signals, obtain sign location data, and convert this data into a stereo sound presentation of exit sign direction.

This development will be accomplished via a Cooperative Research and Development Agreement (CRADA) with Talking Lights LLC, which holds a patent on an electronic ballast that converts standard fluorescent bulbs into digital information transmitters. The company will also provide a PocketPC receiver that decodes their proprietary transmission signal, and a 5-sensor optical array capable of picking up their signal over a 150-degree field. As part of this CRADA, Talking Lights will modify their ballast to match the form-factor of ballasts in exit signs. Further, they will release their proprietary encoder design to VA investigators so that the LED Exit Light design can be made fully compatible with the fluorescent light design.

Once developed and optimized, investigators hypothesize a dramatic improvement in egress performance for all ages of two populations:

  1. people with severe vision loss who use a white cane or dog for mobility, and
  2. people with low vision who do not use a white cane or dog for mobility, yet have problems reading and locating exit signs.

Results will be published and presented for review to the National Fire Prevention Agency (NFPA) for consideration as part of the Life Safety Code, and to the Building Officials and Code Administrators (BOCA) for consideration as part of the National Building Code.

COMPARISONS: Egress using existing emergency exit signage.

Conditions
Blindness
Being tested
Egress Badge
Keywords
Rehabilitation, Sensory Aid
Medical subject headings
Blindness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Egress BadgeDevice

    Egress Badge is worn by subjects who are asked to use the badge to exit the building. The badge indicates the direction of each exit sign on route to an exit.

Study groups in NCT00262509
Study groupRoleWhat they receive
Egress Badge PerformanceExperimentalBlind subjects are walked into a building to a specific location, and then are asked to find their way out of the building.
Receives: Device: Egress Badge
Baseline Egress PerformanceNo interventionBlind subjects are walked into a building to a particular location and then asked to find their way out of the building.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Exit Building

    Subjects are walked into a building to a specific location and then asked to find their way out of the building. Time to Exit Building is measured. This is protocol is performed twice, and the times averaged to obtain the outcome measure.

    Measured: 30 minutes total, 15 minutes for each of two timed trials

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2005 (estimated)
  2. Study startSep 2008
  3. Primary completionDec 2008
  4. Study completionApr 2009

Why it stopped: Intervention worsened performance for first 17 of 24 planned participants.

Resources

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
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00262509
Sponsor's protocol ID
C3905-R
Status last verified
Jan 2014
First submitted
2 Dec 2005
Last updated
11 Feb 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Egress Badge in people with Blindness, run by US Department of Veterans Affairs at 1 site in United States.

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 3 inclusion and 1 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: stopped early, as of the sponsor's last update on 11 Feb 2014. 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 United States. 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?

Yes. Results are posted in the registry (first posted 11 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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.

What does the primary outcome measure?

Time to Exit Building (time frame: 30 minutes total, 15 minutes for each of two timed trials). It is what the study was designed to measure, not a finding.

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 11 Feb 2014.

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