StutteringPhase 1NCT01315730
The Effects of Tactile Speech Feedback on Stuttering Frequency
A Phase 1 study testing Tactile Stimulation in people with Stuttering, run by University of Mississippi, Oxford at 1 site in United States.
Trial summary
The purpose of this research project is to test the effects of exposure of different forms of tactile speech feedback on overt stuttering frequency. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stuttering
- What is being tested?
- Tactile Stimulation
- 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
- Mar 2011to not given
- Phase
- Phase 1
- 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
- Adults diagnosed with persistent developmental stuttering
Who cannot join
- Subjects below 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Mississippi
University, Mississippi, 38677
About this study
The purpose of this research project is to test the effects of exposure of different forms of tactile speech feedback on overt stuttering frequency.
Read the detailed description
A new medical grade device (FDA - category exempt) has been newly designed and built at the University of Mississippi within the departments of Communication Sciences \& Disorders, Exercise Science, and Computer and Electrical Engineering. The device records either sound waves (via a small standard microphone) or three dimensional accelerometer data from the throat of a stuttering subject. This data is digitally signal processed, and "fed back" to the user in the form of a small vibrating disk/film that can be held between the fingers or mounted on the skin. This feedback data does not require the subject to attend to the incoming signal.
- Conditions
- Stuttering
- Being tested
- Tactile Stimulation
- Keywords
- stuttering, haptic, feedback, fluency
- Medical subject headings
- Stuttering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tactile StimulationDevice
See Arms
| Study group | Role | What they receive |
|---|---|---|
| Device: Tactile Stimulation | Experimental | A new medical grade device (FDA - category exempt) has been newly designed and built at the University of Mississippi within the departments of Communication Sciences \& Disorders, Exercise Science, and Computer and Electrical Engineering. The device records either sound waves (via a small standard microphone) or three dimensional accelerometer data from the throat of a stuttering subject. This data is digitally signal processed, and "fed back" to the user in the form of a small vibrating disk/film that can be held between the fingers or mounted on the skin. This feedback data does not require the subject to attend to the incoming signal. Receives: Device: Tactile Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech Fluency
Speech fluency was defined by either reading or saying a set syllable sentence in a book which is normally 8th grade reading level or lower. Pauses or stutters are considered positive indicators of dis-fluent speech.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startMar 2011
Why it stopped: Patent being pursued prior to trial initiation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StutteringStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi, Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- West Virginia University, Auburn University, University of Louisiana at Lafayette
- Responsible party
- Sponsor
- Investigators
- Dwight E Waddell, Ph.D., Principal investigator, The University of Mississippi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315730
- Sponsor's protocol ID
- UMO-0001
- Status last verified
- May 2014
- First submitted
- 11 Mar 2011
- Last updated
- 12 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Snyder GJ, Blanchet P, Waddell D, Ivy LJ. Effects of digital vibrotactile speech feedback on overt stuttering frequency. Percept Mot Skills. 2009 Feb;108(1):271-80. doi: 10.2466/PMS.108.1.271-280.
PubMed 19425468
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Tactile Speech Feedback on Stuttering Frequency
- ClinicalTrials.gov ID
- NCT01315730
- Acronym / sponsor ID
- UMO-0001
- Conditions
- Stuttering
- Keywords
- stuttering, haptic, feedback, fluency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Patent being pursued prior to trial initiation
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Mississippi, OxfordUniversity, hospital or other
- Collaborators
- West Virginia University, Auburn University, University of Louisiana at Lafayette
- Study start
- Mar 2011
- First posted
- 15 Mar 2011 (estimated)
- 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.
The purpose of this research project is to test the effects of exposure of different forms of tactile speech feedback on overt stuttering frequency.
Detailed description
A new medical grade device (FDA - category exempt) has been newly designed and built at the University of Mississippi within the departments of Communication Sciences \& Disorders, Exercise Science, and Computer and Electrical Engineering. The device records either sound waves (via a small standard microphone) or three dimensional accelerometer data from the throat of a stuttering subject. This data is digitally signal processed, and "fed back" to the user in the form of a small vibrating disk/film that can be held between the fingers or mounted on the skin. This feedback data does not require the subject to attend to the incoming signal.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device: Tactile Stimulation | Experimental | Device: Tactile StimulationA new medical grade device (FDA - category exempt) has been newly designed and built at the University of Mississippi within the departments of Communication Sciences \& Disorders, Exercise Science, and Computer and Electrical Engineering. The device records either sound waves (via a small standard microphone) or three dimensional accelerometer data from the throat of a stuttering subject. This data is digitally signal processed, and "fed back" to the user in the form of a small vibrating disk/film that can be held between the fingers or mounted on the skin. This feedback data does not require the subject to attend to the incoming signal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults diagnosed with persistent developmental stuttering
Key exclusion criteria (1 listed)
- Subjects below 18 years of age
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 |
|---|---|---|
| Tactile StimulationSee Arms | Device | Device: Tactile Stimulation |
Primary outcome
Speech Fluency
Time frame: 1 week
Speech fluency was defined by either reading or saying a set syllable sentence in a book which is normally 8th grade reading level or lower. Pauses or stutters are considered positive indicators of dis-fluent speech.
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 12 May 2014.
- Results publication: PubMed 19425468Snyder GJ, Blanchet P, Waddell D, Ivy LJ. Effects of digital vibrotactile speech feedback on overt stuttering frequency. Percept Mot Skills. 2009 Feb;108(1):271-80. doi: 10.2466/PMS.108.1.271-280.
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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.
Dwight E Waddell, Ph.D. principal investigator
The University of Mississippi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tactile Stimulation in people with Stuttering, run by University of Mississippi, Oxford 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 1 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 12 May 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Speech Fluency (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01315730, which also lists 1 linked publication.
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 12 May 2014.