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.
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
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:
- develop Talking Exit Lights with a range of at least 100 feet,
- write software for the user device to accurately indicate the direction of Talking Exit Lights and provide spoken messages,
- optimize the user interface to make it easy and intuitive to use,
- test the accuracy and reliability of the developed system in terms of transmission range and directional accuracy, and
- conduct subject evaluations of the new system.
Two versions of transmitting exit signs will be developed:
- a retro-fit design for existing fluorescent light exit signs, and
- 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:
- people with severe vision loss who use a white cane or dog for mobility, and
- 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 group | Role | What they receive |
|---|---|---|
| Egress Badge Performance | Experimental | Blind 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 Performance | No intervention | Blind 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.
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.
- First posted6 Dec 2005 (estimated)
- Study startSep 2008
- Primary completionDec 2008
- Study completionApr 2009
Why it stopped: Intervention worsened performance for first 17 of 24 planned participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BlindnessStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- David A Ross, MSEE Med, Principal investigator, Atlanta VA Medical and Rehab Center, Decatur
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Egress and Information System for Persons With Vision Loss
- ClinicalTrials.gov ID
- NCT00262509
- Acronym / sponsor ID
- C3905-R
- Conditions
- Blindness
- Keywords
- Rehabilitation, Sensory Aid
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Intervention worsened performance for first 17 of 24 planned participants.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Sep 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 6 Dec 2005 (estimated)
- Results
- Posted 11 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- develop Talking Exit Lights with a range of at least 100 feet,
- write software for the user device to accurately indicate the direction of Talking Exit Lights and provide spoken messages,
- optimize the user interface to make it easy and intuitive to use,
- test the accuracy and reliability of the developed system in terms of transmission range and directional accuracy, and
- conduct subject evaluations of the new system.
Two versions of transmitting exit signs will be developed:
- a retro-fit design for existing fluorescent light exit signs, and
- 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:
- people with severe vision loss who use a white cane or dog for mobility, and
- 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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Egress Badge Performance | Experimental | Device: Egress BadgeBlind subjects are walked into a building to a specific location, and then are asked to find their way out of the building. |
| Baseline Egress Performance | No intervention | –Blind subjects are walked into a building to a particular location and then asked to find their way out of the building. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients currently being treated at Atlanta VA Medical Center
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 |
|---|---|---|
| Egress BadgeEgress 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. | Device | Egress Badge Performance |
Primary outcome
Time to Exit Building
Time frame: 30 minutes total, 15 minutes for each of two timed trials
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David A Ross, MSEE Med principal investigator
Atlanta VA Medical and Rehab Center, Decatur
1 site in 1 country: see every site and its status.
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.