Auditory Rehabilitation in Stroke Patients With Auditory Processing Disorders

Sponsor
University College, London (Other)
Overall Status
Completed
CT.gov ID
NCT02889107
Collaborator
(none)
9
1
2
33
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Study Details

Study Description

Brief Summary

This study aimed to evaluate long term benefits in speech reception in noise, after daily 10 week use of an assisting listening device (personal frequency-modulates systems) , in non-aphasic stroke patients with auditory processing deficits.

Condition or Disease Intervention/Treatment Phase
  • Other: personal frequency modulated systems
N/A

Detailed Description

Stroke can affect all levels of the auditory pathway. Approximately one in five stroke survivors report severe difficulties when listening to speech-in-noise, despite normal hearing, attributed to abnormal processing of sounds within the brain, and these individuals are more likely to experience communication difficulties in poor acoustic environments, The patient with significant auditory deficits and functional limitations may require a range of rehabilitation and remediation approaches. Several studies conclusively demonstrate substantial improvements in speech recognition in noise when using personal frequency-modulated (FM) systems. These devices are used to improve speech perception in noise in adults with neurological disorders including stroke with good immediate benefits. However, the long-term benefits of FM systems in stroke patients has not been studies. In this research study the investigators aimed to investigate the long term benefits in speech reception in noise in non-aphasic stroke patients and measure the potential improvement in unaided speech in background noise performance after 10 weeks.

Study Design

Study Type:
Interventional
Actual Enrollment :
9 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Long-term Use Benefits of Personal Frequency-modulated Systems for Speech in Noise Perception in Stroke Patients With Auditory Processing Deficits- 'a Non-randomised
Study Start Date :
Apr 1, 2013
Actual Primary Completion Date :
Dec 1, 2015
Actual Study Completion Date :
Jan 1, 2016

Arms and Interventions

Arm Intervention/Treatment
No Intervention: standard care

Patients received standard listening strategies for 10 weeks

Experimental: intervention

Patients received an assistive listening device (personal frequency modulated systems) for 10 weeks

Other: personal frequency modulated systems
patients used personal frequency modulated systems for at least 4 hours daily for 10 weeks
Other Names:
  • FM systems
  • Outcome Measures

    Primary Outcome Measures

    1. The signal-to-noise ratio (SNR) benefit for speech in noise (reported in decibel, dB) [week 1]

      Patients are tested in a sound attenuated booth (the crescent of sound) with nine audio stands, an equipment cabinet, and a testing station for the assessment of spatial-listening skills. A 'Speech in noise' test was used. In this test, recorded spoken sentences are presented from straight ahead (0°) while noise is also coming from 90° to the left or right from the participant, who is asked to repeat the sentence. The number of keywords successfully repeated is recorded and repetition of at least three keywords per sentence is required to judge correct performance. The level of the sentences and the background noise are adaptively varied to estimate the signal-to-noise ratio (SNR) for 50% correct performance. The test was conducted with the participant using the frequency modulated systems (aided condition) or not using the frequency modulated systems (unaided condition). The level of SNR is reported in dB.

    Secondary Outcome Measures

    1. The signal-to-noise ratio (SNR) benefit for speech in noise (reported in decibel, dB) [week 10]

      Patients are tested in a sound attenuated booth (the crescent of sound) with nine audio stands, an equipment cabinet, and a testing station for the assessment of spatial-listening skills. A 'Speech in noise' test was used. In this test, recorded spoken sentences are presented from straight ahead (0°) while noise is also coming from 90° to the left or right from the participant, who is asked to repeat the sentence. The number of keywords successfully repeated is recorded and repetition of at least three keywords per sentence is required to judge correct performance. The level of the sentences and the background noise are adaptively varied to estimate the signal-to-noise ratio (SNR) for 50% correct performance. The test was conducted with the participant using the frequency modulated systems (aided condition) or not using the frequency modulated systems (unaided condition). The level of SNR is reported in dB.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Clinical history of ischaemic stroke verified by brain magnetic resonance imaging (MRI)

    • Diagnosis of auditory processing disorders

    • Normal pure-tone audiogram

    Exclusion Criteria:
    • Severe aphasia

    • Significant psychiatric illnesses

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University College London Hospitals London United Kingdom

    Sponsors and Collaborators

    • University College, London

    Investigators

    • Principal Investigator: Doris-Eva Bamiou, PhD, University College, London

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Doris-Eva Bamiou, Reader & Consultant in Audiovestibular Medicine, University College, London
    ClinicalTrials.gov Identifier:
    NCT02889107
    Other Study ID Numbers:
    • 11/LO/1675
    First Posted:
    Sep 5, 2016
    Last Update Posted:
    Sep 5, 2016
    Last Verified:
    Aug 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 5, 2016