Speech Sound DisordersPhase 1NCT01905449
Ultrasound Biofeedback for Speech Sound Disorders
A Phase 1 study testing Ultrasound visual feedback in people with Speech Sound Disorders, run by Yale University at 1 site in United States.
Trial summary
Children with speech sound disorders will receive speech therapy using real-time images of the tongue from ultrasound. These images will be used to cue the child to change the tongue position when producing speech sounds. Read more about this study
- Who is it for?
- Ages 8 to 50 years
- Conditions the study is for
- Speech Sound Disorders
- What is being tested?
- Ultrasound visual feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Jul 2016
- 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 8 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants must be native English-speaking children with no known hearing or vision deficits. Participants must be within the specified age range and have been identified as having speech production difficulties by a local speech-language therapist.
Who cannot join
- Participants will be excluded if there is a history of oral structural impairment (e.g., cleft palate), hearing or vision impairment, history of neurological impairment or injury, developmental disabilities such as Down Syndrome or Autism, or intellectual disability.
- During initial testing, participants must score below a standard score of 75 on the Goldman-Fristoe Test of Articulation-2 and also score below 20% accurate on a probe list of words assessing accuracy of the /r/ sound
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biofeedback and Speech Disorders
Children with speech sound disorders will receive speech therapy using real-time images of the tongue from ultrasound. These images will be used to cue the child to change the tongue position when producing speech sounds.
- Conditions
- Speech Sound Disorders
- Being tested
- Ultrasound visual feedback
- Medical subject headings
- Speech Sound Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound visual feedbackBehavioural
Real-time visual displays of the tongue are used to cue participants to modify the tongue position/shape as they articulate speech sounds
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound plus prosodic cues | Experimental | One sound in error is treated with ultrasound visual feedback while also cueing prosodic variation (7 one-hour sessions). Another sound in error is treated with the ultrasound visual feedback with no prosodic variation (7 one-hour sessions). Prosodic variations are cues to coordinate production of the target sound with intonation patterns such as questions (rising intonations), commands (loud/emphatic), or statements (neutral) Receives: Behavioral: Ultrasound visual feedback |
| Ultrasound vs Traditional treatment | Experimental | One sound in errors is treated with ultrasound visual feedback for approximately half of each session and traditional treatment for half of the session (7 one-hour sessions). Another sound in error is treated with no ultrasound visual feedback, using traditional treatment for the entire session (7 one-hour sessions). These traditional cues include verbal instructions on how to move the tongue to achieve a particular speech sound. Receives: Behavioral: Ultrasound visual feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent correct for target speech sound
Measured: Change in accuracy after 7 one-hour treatment sessions (3.5 weeks), and after 14 one-hour treatment sessions (7 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startMay 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Speech Sound DisordersStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Preston, PhD, Principal investigator, Haskins Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01905449
- Sponsor's protocol ID
- 1303011662
- Status last verified
- Apr 2020
- First submitted
- 16 Jul 2013
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biofeedback and Speech Disorders
- ClinicalTrials.gov ID
- NCT01905449
- Acronym / sponsor ID
- 1303011662
- Conditions
- Speech Sound Disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 23 Jul 2013 (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.
Children with speech sound disorders will receive speech therapy using real-time images of the tongue from ultrasound. These images will be used to cue the child to change the tongue position when producing speech sounds.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound plus prosodic cues | Experimental | Behavioral: Ultrasound visual feedbackOne sound in error is treated with ultrasound visual feedback while also cueing prosodic variation (7 one-hour sessions). Another sound in error is treated with the ultrasound visual feedback with no prosodic variation (7 one-hour sessions). Prosodic variations are cues to coordinate production of the target sound with intonation patterns such as questions (rising intonations), commands (loud/emphatic), or statements (neutral) |
| Ultrasound vs Traditional treatment | Experimental | Behavioral: Ultrasound visual feedbackOne sound in errors is treated with ultrasound visual feedback for approximately half of each session and traditional treatment for half of the session (7 one-hour sessions). Another sound in error is treated with no ultrasound visual feedback, using traditional treatment for the entire session (7 one-hour sessions). These traditional cues include verbal instructions on how to move the tongue to achieve a particular speech sound. |
Who may qualify
- Ages
- 8 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Participants must be native English-speaking children with no known hearing or vision deficits. Participants must be within the specified age range and have been identified as having speech production difficulties by a local speech-language therapist.
Key exclusion criteria (2 listed)
- Participants will be excluded if there is a history of oral structural impairment (e.g., cleft palate), hearing or vision impairment, history of neurological impairment or injury, developmental disabilities such as Down Syndrome or Autism, or intellectual disability.
- During initial testing, participants must score below a standard score of 75 on the Goldman-Fristoe Test of Articulation-2 and also score below 20% accurate on a probe list of words assessing accuracy of the /r/ sound
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 |
|---|---|---|
| Ultrasound visual feedbackReal-time visual displays of the tongue are used to cue participants to modify the tongue position/shape as they articulate speech sounds | Behavioural | Ultrasound plus prosodic cues, Ultrasound vs Traditional treatment |
Primary outcome
Percent correct for target speech sound
Time frame: Change in accuracy after 7 one-hour treatment sessions (3.5 weeks), and after 14 one-hour treatment sessions (7 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Related InfoLink provided by the sponsor.
Related trials for Speech Sound Disorders
RecruitingPhase 1
Treatment Targets in Spanish and English Bilingual Speech Intervention
Speech Sound Disorder
RecruitingPhase 2
Visual-acoustic Intervention With Service Delivery In-person and Via Telepractice Trial
Speech Sound Disorder
Recruiting
Feasibility and Preliminary Effects of a Therapeutic Approach Using Ultrasound Visual Biofeedback in Children With AFI: a Pilot Randomized Clinical Trial.
Childhood Apraxia of Speech, Speech Sound Disorders
Recruiting
Improving Spatial Perception and Speech Understanding in Multitalker Mixtures
Hearing Loss
Recruiting
BiOfeedback, Online for Sibilant Treatment
Speech Sound Disorder
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.
Jonathan Preston, PhD principal investigator
Haskins Laboratories
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 Ultrasound visual feedback in people with Speech Sound Disorders, run by Yale University 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 2 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: finished, as of the sponsor's last update on 3 Apr 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percent correct for target speech sound (time frame: Change in accuracy after 7 one-hour treatment sessions (3.5 weeks), and after 14 one-hour treatment sessions (7 weeks)). 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 3 Apr 2020.