Apraxia of SpeechNCT02094014
Auditory Masking Effects on Speech Fluency in Aphasia and Apraxia of Speech
An observational study of Apraxia of Speech and Aphasia, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Impaired speech production is a major obstacle to full participation in life roles by stroke survivors with aphasia and apraxia of speech. The proposed study will demonstrate the short-term effects of auditory masking on speech disfluencies and identify individual factors that predict a positive response, enabling… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Apraxia of Speech, Aphasia, Cerebrovascular Accident
- What is being tested?
- Normal Auditory Feedback, Masked Auditory Feedback and Altered Auditory Feedback
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Dec 2015
- Phase
- Observational
- 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
Study population: Participants with aphasia (PWA) will be referred from existing referral sources (e.g. UNC Stroke registry, Triangle Aphasia Project), clinicians in the community, and the Carolina Data Warehouse for Health.
Who may be able to join
- Single left-hemisphere cerebrovascular accident
- Speech errors are present, but participant is able to produce approximations of words or sentences by reading or repetition; < 90% and > 10% on Chapel Hill Multilingual Intelligibility Test (Haley, 2011)
- Right-handed prior to stroke by report
- Normal visual attention, acuity, and color vision
- Pure-tone threshold <= 40 decibels in at least one ear
- Matched in age and sex to a participant with aphasia
Show all 10Show fewer
- score of 90% or higher on the single-word intelligibility test
- Right-handed prior to stroke by report
- Normal visual attention, acuity, and color vision
- Pure-tone threshold <= 40 decibels in at least one ear
Who cannot join
- Predominating disorders of cognition or hearing (e.g. dementia, hearing impairment).
- Presence of degenerative neurological illness (e.g. Parkinson's disease, amyotrophic lateral sclerosis, primary progressive aphasia).
- History of stroke
- History of developmental speech or language disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina School of Medicine
Chapel Hill, North Carolina, 27599-7190
About this study
Impaired speech production is a major obstacle to full participation in life roles by stroke survivors with aphasia and apraxia of speech. The proposed study will demonstrate the short-term effects of auditory masking on speech disfluencies and identify individual factors that predict a positive response, enabling future work to develop auditory masking as a treatment adjuvant targeting long-term improvement in speech. Providing an additional treatment option for adults with aphasia and apraxia of speech will have the clear benefit of improving quality of life and allowing individuals to participate more actively in their health care decisions through improved communication.
Read the detailed description
The objective of this research is to test the short-term effects of listening to noise (i.e. auditory feedback masking) on speech fluency in stroke survivors with aphasia and apraxia of speech. People with nonfluent types of aphasia frequently have apraxia of speech, which affects the motor programming of speech movements, causing distortions, slow rate, and speech disfluencies that impede the forward flow of communication. Speaking while listening to noise (e.g. auditory masking) is known to reduce disfluencies and increase speech rate in people who stutter. This method has been tested in people with aphasia, resulting in positive effects on speech production for a subset of those tested. The investigators contend that individuals who have apraxia of speech in addition to aphasia are most likely to benefit from auditory masking, but most previous studies did not test participants for apraxia of speech. In addition, though masking is most likely to affect speech disfluencies, previous studies did not measures disfluencies. The proposed work has two specific aims. Aim 1 will determine the short-term effect of auditory masking, provided on a single day, on speech fluency in stroke survivors with aphasia and apraxia of speech. Aim 2 will identify individual factors that predict a positive response, including presence of apraxia of speech, lesion characteristics, and type of aphasia (e.g. Broca's, Wernicke's). Voxel-based lesion analysis techniques will be used to determine sites of lesion associated with positive and negative response to auditory masking. Completion of this study will remove barriers to studying auditory masking as a technique for clinical intervention, but also as a research tool for behavioral neuroscientists probing the speech motor control system in speakers with aphasia and apraxia of speech.
- Conditions
- Apraxia of Speech, Aphasia, Cerebrovascular Accident
- Being tested
- Normal Auditory Feedback, Masked Auditory Feedback, Altered Auditory Feedback
- Keywords
- Perceptual masking, Auditory stimulation, Speech, Language, Verbal Fluency Disorders
- Medical subject headings
- Apraxias, Aphasia, Stroke, Speech, Language, Speech Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal Auditory FeedbackBehavioural
Participants will produce sentences under normal speaking conditions, able to hear their own speech.
Masked Auditory FeedbackBehavioural
Also called Masking Noise
Participants will produce sentences while listening to speech-shaped noise at 85 decibels (sound pressure level) to mask ability to hear their own speech.
Altered Auditory FeedbackBehavioural
Also called Delayed and pitch-shifted feedback
Participants will produce sentences while listening to their speech shifted up one octave and delayed.
| Study group | Role | What they receive |
|---|---|---|
| Aphasic/Apraxic Participants | The aphasic/apraxic participant group will include 30 adults who have had strokes affecting their ability to communicate verbally, broadly classified as aphasic and including individuals with and without apraxia of speech (AOS).
Participants will speak under Masked Auditory Feedback, Altered Auditory Feedback, and Normal Auditory Feedback. Receives: Behavioral: Normal Auditory Feedback; Behavioral: Masked Auditory Feedback; Behavioral: Altered Auditory Feedback | |
| Neurologically Healthy Participants | The neurologically healthy participant group will include 15 adults with no history of stroke or developmental speech or language disorder.
Participants will speak under Masked Auditory Feedback, Altered Auditory Feedback, and Normal Auditory Feedback. Receives: Behavioral: Normal Auditory Feedback; Behavioral: Masked Auditory Feedback; Behavioral: Altered Auditory Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disfluency duration change with masking noise
Measured disfluency duration in sentences produced while listening to masking noise compared to speaking in quiet without noise.
Measured: 1 day of the study
Secondary outcomes (2)
Speech rate change with masking noise
Measured syllables per second in sentences produced while listening to masking noise compared to speaking in quiet without noise.
Measured: 1 day of the study
Speech sound accuracy change with masking noise
Measured speech sound accuracy in sentences produced while listening to masking noise compared to speaking in quiet without noise.
Measured: 1 day of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apraxia of SpeechStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Adam Jacks, Ph.D., Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02094014
- Sponsor's protocol ID
- 10-0503
- Other IDs
- R03DC011881
- Status last verified
- May 2016
- First submitted
- 13 Mar 2014
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auditory Masking Effects on Speech Fluency in Aphasia and Apraxia of Speech
- ClinicalTrials.gov ID
- NCT02094014
- Acronym / sponsor ID
- 10-0503
- Conditions
- Apraxia of Speech, Aphasia, Cerebrovascular Accident
- Keywords
- Perceptual masking, Auditory stimulation, Speech, Language, Verbal Fluency Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- Mar 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 Mar 2014 (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.
Impaired speech production is a major obstacle to full participation in life roles by stroke survivors with aphasia and apraxia of speech. The proposed study will demonstrate the short-term effects of auditory masking on speech disfluencies and identify individual factors that predict a positive response, enabling future work to develop auditory masking as a treatment adjuvant targeting long-term improvement in speech. Providing an additional treatment option for adults with aphasia and apraxia of speech will have the clear benefit of improving quality of life and allowing individuals to participate more actively in their health care decisions through improved communication.
Detailed description
The objective of this research is to test the short-term effects of listening to noise (i.e. auditory feedback masking) on speech fluency in stroke survivors with aphasia and apraxia of speech. People with nonfluent types of aphasia frequently have apraxia of speech, which affects the motor programming of speech movements, causing distortions, slow rate, and speech disfluencies that impede the forward flow of communication. Speaking while listening to noise (e.g. auditory masking) is known to reduce disfluencies and increase speech rate in people who stutter. This method has been tested in people with aphasia, resulting in positive effects on speech production for a subset of those tested. The investigators contend that individuals who have apraxia of speech in addition to aphasia are most likely to benefit from auditory masking, but most previous studies did not test participants for apraxia of speech. In addition, though masking is most likely to affect speech disfluencies, previous studies did not measures disfluencies. The proposed work has two specific aims. Aim 1 will determine the short-term effect of auditory masking, provided on a single day, on speech fluency in stroke survivors with aphasia and apraxia of speech. Aim 2 will identify individual factors that predict a positive response, including presence of apraxia of speech, lesion characteristics, and type of aphasia (e.g. Broca's, Wernicke's). Voxel-based lesion analysis techniques will be used to determine sites of lesion associated with positive and negative response to auditory masking. Completion of this study will remove barriers to studying auditory masking as a technique for clinical intervention, but also as a research tool for behavioral neuroscientists probing the speech motor control system in speakers with aphasia and apraxia of speech.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aphasic/Apraxic Participants | – | Behavioral: Normal Auditory Feedback, Behavioral: Masked Auditory Feedback, Behavioral: Altered Auditory FeedbackThe aphasic/apraxic participant group will include 30 adults who have had strokes affecting their ability to communicate verbally, broadly classified as aphasic and including individuals with and without apraxia of speech (AOS). Participants will speak under Masked Auditory Feedback, Altered Auditory Feedback, and Normal Auditory Feedback. |
| Neurologically Healthy Participants | – | Behavioral: Normal Auditory Feedback, Behavioral: Masked Auditory Feedback, Behavioral: Altered Auditory FeedbackThe neurologically healthy participant group will include 15 adults with no history of stroke or developmental speech or language disorder. Participants will speak under Masked Auditory Feedback, Altered Auditory Feedback, and Normal Auditory Feedback. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with aphasia (PWA) will be referred from existing referral sources (e.g. UNC Stroke registry, Triangle Aphasia Project), clinicians in the community, and the Carolina Data Warehouse for Health.
Key inclusion criteria (10 listed)
- Single left-hemisphere cerebrovascular accident
- Speech errors are present, but participant is able to produce approximations of words or sentences by reading or repetition; < 90% and > 10% on Chapel Hill Multilingual Intelligibility Test (Haley, 2011)
- Right-handed prior to stroke by report
- Normal visual attention, acuity, and color vision
- Pure-tone threshold <= 40 decibels in at least one ear
Key exclusion criteria (4 listed)
- Predominating disorders of cognition or hearing (e.g. dementia, hearing impairment).
- Presence of degenerative neurological illness (e.g. Parkinson's disease, amyotrophic lateral sclerosis, primary progressive aphasia).
- History of stroke
- History of developmental speech or language disorder
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 |
|---|---|---|
| Normal Auditory FeedbackParticipants will produce sentences under normal speaking conditions, able to hear their own speech. | Behavioural | Aphasic/Apraxic Participants, Neurologically Healthy Participants |
| Masked Auditory FeedbackAlso: Masking NoiseParticipants will produce sentences while listening to speech-shaped noise at 85 decibels (sound pressure level) to mask ability to hear their own speech. | Behavioural | Aphasic/Apraxic Participants, Neurologically Healthy Participants |
| Altered Auditory FeedbackAlso: Delayed and pitch-shifted feedbackParticipants will produce sentences while listening to their speech shifted up one octave and delayed. | Behavioural | Aphasic/Apraxic Participants, Neurologically Healthy Participants |
Primary outcome
Disfluency duration change with masking noise
Time frame: 1 day of the study
Measured disfluency duration in sentences produced while listening to masking noise compared to speaking in quiet without noise.
2 secondary outcomes
Speech rate change with masking noise
Time frame: 1 day of the study
Speech sound accuracy change with masking noise
Time frame: 1 day of the study
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 12 May 2016.
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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.
Adam Jacks, Ph.D. principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Apraxia of Speech and Aphasia, run by University of North Carolina, Chapel Hill 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 10 inclusion and 4 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 12 May 2016. 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 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?
Disfluency duration change with masking noise (time frame: 1 day of the study). 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 12 May 2016.