- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02889107
Auditory Rehabilitation in Stroke Patients With Auditory Processing Disorders
August 30, 2016 updated by: Doris-Eva Bamiou, University College, London
Long-term Use Benefits of Personal Frequency-modulated Systems for Speech in Noise Perception in Stroke Patients With Auditory Processing Deficits- 'a Non-randomised
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
9
Phase
- Not Applicable
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
-
-
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London, United Kingdom
- University College London Hospitals
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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
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
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patients used personal frequency modulated systems for at least 4 hours daily for 10 weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The signal-to-noise ratio (SNR) benefit for speech in noise (reported in decibel, dB)
Time Frame: 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.
|
week 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The signal-to-noise ratio (SNR) benefit for speech in noise (reported in decibel, dB)
Time Frame: 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.
|
week 10
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Doris-Eva Bamiou, PhD, University College, London
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
April 1, 2013
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
August 23, 2016
First Submitted That Met QC Criteria
August 30, 2016
First Posted (Estimate)
September 5, 2016
Study Record Updates
Last Update Posted (Estimate)
September 5, 2016
Last Update Submitted That Met QC Criteria
August 30, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Otorhinolaryngologic Diseases
- Ear Diseases
- Cognition Disorders
- Language Disorders
- Communication Disorders
- Perceptual Disorders
- Retrocochlear Diseases
- Auditory Diseases, Central
- Stroke
- Language Development Disorders
- Auditory Perceptual Disorders
Other Study ID Numbers
- 11/LO/1675
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
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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