Hearing ImpairmentNCT03966144
RoboHear™ Device: Advanced Haptic Technology That Allows the Deaf to Understand Speech
A study testing RoboHear Device in people with Hearing Impairment and Deafness, run by University of Arkansas at 1 site in United States.
Trial summary
Pilot study to test the feasibility of translating the English language into haptics (touch sensations) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Impairment, Deafness
- What is being tested?
- RoboHear Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2020to 25 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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).
Who cannot join
- Inability to understand English
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Pilot study to test the feasibility of translating the English language into haptics (touch sensations)
Read the 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.
- Conditions
- Hearing Impairment, Deafness
- Being tested
- RoboHear Device
- Medical subject headings
- Hearing Loss, Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RoboHear DeviceDevice
Delivery of haptic sensations followed by testing to assess the ability to interpret stimuli as sounds and words
| Study group | Role | What they receive |
|---|---|---|
| RoboHear Device | Experimental | 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. Receives: Device: RoboHear Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haptic Interpretation Test
A computerized test to determine accuracy of interpretation of haptic stimuli in to sounds or words.
Measured: at end of training session (1-3 hours), Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start25 Mar 2020
- Primary completion25 Mar 2020
- Study completion25 Mar 2020
Why it stopped: Company discontinued study and closed. No participants were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing ImpairmentStudies 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
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John L Dornhoffer, MD, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966144
- Sponsor's protocol ID
- 228355
- Status last verified
- May 2020
- First submitted
- 23 May 2019
- Last updated
- 20 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RoboHear™ Device: Advanced Haptic Technology That Allows the Deaf to Understand Speech
- ClinicalTrials.gov ID
- NCT03966144
- Acronym / sponsor ID
- 228355
- Conditions
- Hearing Impairment, Deafness
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Company discontinued study and closed. No participants were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 25 Mar 2020 (actual)
- Primary completion
- 25 Mar 2020 (actual)
- Study completion
- 25 Mar 2020 (actual)
- First posted
- 29 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will undergo computer based testing using the device to determine the number of haptic stimuli that are correctly interpreted as phenomes.
| Arm | Type | Receives |
|---|---|---|
| RoboHear Device | Experimental | Device: RoboHear DeviceSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- Inability to understand English
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 |
|---|---|---|
| RoboHear DeviceDelivery of haptic sensations followed by testing to assess the ability to interpret stimuli as sounds and words | Device | RoboHear Device |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
- Individual participant dataSharing planned: No
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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.
John L Dornhoffer, MD, PhD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RoboHear Device in people with Hearing Impairment and Deafness, run by University of Arkansas 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 2 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: withdrawn, as of the sponsor's last update on 20 May 2020. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Haptic Interpretation Test (time frame: at end of training session (1-3 hours), Day 1). 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 20 May 2020.