NCT02094014

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 21, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

1.8 years

First QC Date

March 13, 2014

Last Update Submit

May 10, 2016

Conditions

Keywords

Perceptual maskingAuditory stimulationSpeechLanguageVerbal Fluency Disorders

Outcome Measures

Primary Outcomes (1)

  • Disfluency duration change with masking noise

    Measured disfluency duration in sentences produced while listening to masking noise compared to speaking in quiet without noise.

    1 day of the study

Secondary Outcomes (2)

  • Speech rate change with masking noise

    1 day of the study

  • Speech sound accuracy change with masking noise

    1 day of the study

Study Arms (2)

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 FeedbackBehavioral: Masked Auditory FeedbackBehavioral: 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.

Behavioral: Normal Auditory FeedbackBehavioral: Masked Auditory FeedbackBehavioral: Altered Auditory Feedback

Interventions

Participants will produce sentences under normal speaking conditions, able to hear their own speech.

Aphasic/Apraxic ParticipantsNeurologically Healthy Participants

Participants will produce sentences while listening to speech-shaped noise at 85 decibels (sound pressure level) to mask ability to hear their own speech.

Also known as: Masking Noise
Aphasic/Apraxic ParticipantsNeurologically Healthy Participants

Participants will produce sentences while listening to their speech shifted up one octave and delayed.

Also known as: Delayed and pitch-shifted feedback
Aphasic/Apraxic ParticipantsNeurologically Healthy Participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina School of Medicine

Chapel Hill, North Carolina, 27599-7190, United States

Location

MeSH Terms

Conditions

ApraxiasAphasiaStrokeSpeechLanguageSpeech Disorders

Condition Hierarchy (Ancestors)

Psychomotor DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsLanguage DisordersCommunication DisordersCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesVerbal BehaviorCommunicationBehavior

Study Officials

  • Adam Jacks, Ph.D.

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2014

First Posted

March 21, 2014

Study Start

March 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 12, 2016

Record last verified: 2016-05

Locations