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RoboHear™ Device: Advanced Haptic Technology That Allows the Deaf to Understand Speech

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ClinicalTrials.gov Identifier: NCT03966144
Recruitment Status : Not yet recruiting
First Posted : May 29, 2019
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Brief Summary:
Pilot study to test the feasibility of translating the English language into haptics (touch sensations)

Condition or disease Intervention/treatment Phase
Hearing Impairment Deafness Device: RoboHear Device Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Device Feasibility
Official Title: RoboHear™ Device: Advanced Haptic Technology That Allows the Deaf to Understand Speech
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RoboHear Device
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.
Device: RoboHear Device
Delivery of haptic sensations followed by testing to assess the ability to interpret stimuli as sounds and words




Primary Outcome Measures :
  1. Haptic Interpretation Test [ Time Frame: at end of training session (1-3 hours), Day 1 ]
    A computerized test to determine accuracy of interpretation of haptic stimuli in to sounds or words.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03966144


Contacts
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Contact: John L Dornhoffer, MD, PhD 501-603-1212 DornhofferJohnL@uams.edu
Contact: Deanne King, MD, PhD 501-686-5427 DKing3@uams.edu

Locations
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United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
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Principal Investigator: John L Dornhoffer, MD, PhD University of Arkansas
  Study Documents (Full-Text)

Documents provided by University of Arkansas:

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Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT03966144     History of Changes
Other Study ID Numbers: 228355
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
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Deafness
Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms