Auditory Masking Effects on Speech Fluency in Aphasia and Apraxia of Speech

May 10, 2016 updated by: University of North Carolina, Chapel Hill
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7190
        • University of North Carolina School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria for Aphasic/Apraxic Participants:

  • 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

Exclusion Criteria for Aphasic/Apraxic Participants:

  • 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).

Inclusion Criteria for Neurologically Healthy Participants:

  • Matched in age and sex to a participant with aphasia
  • 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

Exclusion Criteria for Neurologically Healthy Participants:

  • History of stroke
  • History of developmental speech or language disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Normal Auditory Feedback
Participants will produce sentences under normal speaking conditions, able to hear their own speech.
Behavioral: Masked Auditory Feedback
Participants will produce sentences while listening to speech-shaped noise at 85 decibels (sound pressure level) to mask ability to hear their own speech.
Other Names:
  • Masking Noise
Behavioral: Altered Auditory Feedback
Participants will produce sentences while listening to their speech shifted up one octave and delayed.
Other Names:
  • Delayed and pitch-shifted 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.
Behavioral: Normal Auditory Feedback
Participants will produce sentences under normal speaking conditions, able to hear their own speech.
Behavioral: Masked Auditory Feedback
Participants will produce sentences while listening to speech-shaped noise at 85 decibels (sound pressure level) to mask ability to hear their own speech.
Other Names:
  • Masking Noise
Behavioral: Altered Auditory Feedback
Participants will produce sentences while listening to their speech shifted up one octave and delayed.
Other Names:
  • Delayed and pitch-shifted feedback

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 day of the study

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Speech rate change with masking noise
Time Frame: 1 day of the study
Measured syllables per second in sentences produced while listening to masking noise compared to speaking in quiet without noise.
1 day of the study
Speech sound accuracy change with masking noise
Time Frame: 1 day of the study
Measured speech sound accuracy in sentences produced while listening to masking noise compared to speaking in quiet without noise.
1 day of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of North Carolina, Chapel Hill

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Adam Jacks, Ph.D., University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 21, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10-0503
  • R03DC011881 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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