ClinicalTrials.gov
ClinicalTrials.gov Menu

Auditory Rehabilitation in Stroke Patients With Auditory Processing Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02889107
Recruitment Status : Completed
First Posted : September 5, 2016
Last Update Posted : September 5, 2016
Sponsor:
Information provided by (Responsible Party):
Doris-Eva Bamiou, University College, London

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
Auditory Processing Disorder, Central Stroke Other: personal frequency modulated systems Not Applicable

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  (Clinical Trial)
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 : April 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Noise

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 Name: FM systems




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02889107


Locations
United Kingdom
University College London Hospitals
London, United Kingdom
Sponsors and Collaborators
University College, London
Investigators
Principal Investigator: Doris-Eva Bamiou, PhD University College, London

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Doris-Eva Bamiou, Reader & Consultant in Audiovestibular Medicine, University College, London
ClinicalTrials.gov Identifier: NCT02889107     History of Changes
Other Study ID Numbers: 11/LO/1675
First Posted: September 5, 2016    Key Record Dates
Last Update Posted: September 5, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Stroke
Auditory Perceptual Disorders
Language Development Disorders
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Auditory Diseases, Central
Retrocochlear Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Language Disorders
Communication Disorders