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Auditory Rehabilitation in Stroke Patients With Auditory Processing Disorders

Primary Purpose

Auditory Processing Disorder, Central, Stroke

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
personal frequency modulated systems
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Auditory Processing Disorder, Central

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University College London Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

standard care

intervention

Arm Description

Patients received standard listening strategies for 10 weeks

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

Outcomes

Primary Outcome Measures

The signal-to-noise ratio (SNR) benefit for speech in noise (reported in decibel, dB)
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

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

Full Information

First Posted
August 23, 2016
Last Updated
August 30, 2016
Sponsor
University College, London
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1. Study Identification

Unique Protocol Identification Number
NCT02889107
Brief Title
Auditory Rehabilitation in Stroke Patients With Auditory Processing Disorders
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 Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College, London

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Auditory Processing Disorder, Central, Stroke

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
standard care
Arm Type
No Intervention
Arm Description
Patients received standard listening strategies for 10 weeks
Arm Title
intervention
Arm Type
Experimental
Arm Description
Patients received an assistive listening device (personal frequency modulated systems) for 10 weeks
Intervention Type
Other
Intervention Name(s)
personal frequency modulated systems
Other Intervention Name(s)
FM systems
Intervention Description
patients used personal frequency modulated systems for at least 4 hours daily for 10 weeks
Primary Outcome Measure Information:
Title
The signal-to-noise ratio (SNR) benefit for speech in noise (reported in decibel, dB)
Description
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.
Time Frame
week 1
Secondary Outcome Measure Information:
Title
The signal-to-noise ratio (SNR) benefit for speech in noise (reported in decibel, dB)
Description
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.
Time Frame
week 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doris-Eva Bamiou, PhD
Organizational Affiliation
University College, London
Official's Role
Principal Investigator
Facility Information:
Facility Name
University College London Hospitals
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
28389484
Citation
Koohi N, Vickers D, Warren J, Werring D, Bamiou DE. Long-term use benefits of personal frequency-modulated systems for speech in noise perception in patients with stroke with auditory processing deficits: a non-randomised controlled trial study. BMJ Open. 2017 Apr 7;7(4):e013003. doi: 10.1136/bmjopen-2016-013003.
Results Reference
derived

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Auditory Rehabilitation in Stroke Patients With Auditory Processing Disorders

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