Back to resultsRoboHear™ Device: Advanced Haptic Technology That Allows the Deaf to Understand Speech
Primary Purpose
Hearing Impairment, Deafness
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RoboHear Device
Sponsored by
About this trial
This is an interventional device feasibility trial for Hearing Impairment
Eligibility Criteria
Inclusion Criteria:
- Participants need to understand English.
- Participants must be able to sit at a computer for the training and evaluation session. The session may range from one hour to up to 4 hours in length (with breaks provided as needed).
Exclusion Criteria:
- Inability to understand English
Sites / Locations
- University of Arkansas for Medical Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
RoboHear Device
Arm Description
Subjects will wear the Robo-Hear device and receive haptic stimuli. They will be tested on their ability to interpret these haptic sensations as sounds and words.
Outcomes
Primary Outcome Measures
Haptic Interpretation Test
A computerized test to determine accuracy of interpretation of haptic stimuli in to sounds or words.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03966144
Brief Title
RoboHear™ Device: Advanced Haptic Technology That Allows the Deaf to Understand Speech
Official Title
RoboHear™ Device: Advanced Haptic Technology That Allows the Deaf to Understand Speech
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Company discontinued study and closed. No participants were enrolled.
Study Start Date
March 25, 2020 (Actual)
Primary Completion Date
March 25, 2020 (Actual)
Study Completion Date
March 25, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
Brief Summary
Pilot study to test the feasibility of translating the English language into haptics (touch sensations)
Detailed Description
An adaptive pilot trial of RoboHear™ hardware and software to test the feasibility of learning to understand language using a haptic (touch) device installed in the stem of a pair of glasses. These tests are not meant to be exhaustive but will validate the hardware and software and provide an informal test platform for learning to 'hear' or interpret sounds and words using haptic technology.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Impairment, Deafness
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Participants will undergo computer based testing using the device to determine the number of haptic stimuli that are correctly interpreted as phenomes.
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RoboHear Device
Arm Type
Experimental
Arm Description
Subjects will wear the Robo-Hear device and receive haptic stimuli. They will be tested on their ability to interpret these haptic sensations as sounds and words.
Intervention Type
Device
Intervention Name(s)
RoboHear Device
Intervention Description
Delivery of haptic sensations followed by testing to assess the ability to interpret stimuli as sounds and words
Primary Outcome Measure Information:
Title
Haptic Interpretation Test
Description
A computerized test to determine accuracy of interpretation of haptic stimuli in to sounds or words.
Time Frame
at end of training session (1-3 hours), Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participants need to understand English.
Participants must be able to sit at a computer for the training and evaluation session. The session may range from one hour to up to 4 hours in length (with breaks provided as needed).
Exclusion Criteria:
Inability to understand English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John L Dornhoffer, MD, PhD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
RoboHear™ Device: Advanced Haptic Technology That Allows the Deaf to Understand Speech
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