- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02111343
The Effectiveness of Computerized Auditory Training Programme on Children With Auditory Processing Disorder (CBAT)
Pilot Study: The Effectiveness of Computerized Auditory Training Programme on Children With Auditory Processing Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This prospective study incorporated a parallel group design that randomly assigned participants identified with CAPD to an auditory training (AT) group or a no intervention (Control) group. Both groups were matched for age and gender. Baseline measures were conducted prior to the randomisation process.
Participants from the AT group were given a 3-month home therapy using a CBAT programme developed for this study, while participants from the control group received no intervention for the same period of time. Apart from regular school attendance and activities, all participants were requested to discontinue any other auditory-based interventions, which might affect the outcomes of this study. All the participants were assessed again after the conclusion of the training period.
After the end of the intervention, participants from the AT group were requested to undergo a no-intervention phase for a period of 3 months before another assessment. This was intended to examine the sustainability of any improvement made through the CBAT programme.
An auditory test and two validated questionnaires were used as outcome measures, administered at baseline, and at post-3 months (immediately post-intervention).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Singapore, Singapore, 119074
- National University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Presentation to the clinic with reported symptoms of listening difficulties.
- No measurable peripheral hearing anomalies in both ears, i.e. normal cochlea and middle ear function, as judged by normal audiometric thresholds of 20dB HL or better in the speech frequency range of 250-8000 Hz, and normal impedance audiometry.
Performance on the behavioural AP test battery (Table 6.1) which met the following criteria:
- At least two abnormalities in the non-speech or minimally-linguistic loaded tasks.
- No indication of any other underlying higher order cognitive problems as judged by abnormal performance scores in all the tasks in AP test battery.
- Normal intelligence, as judged by having a nonverbal IQ score of more than 85 (Test of Nonverbal Intelligence, TONI).
Exclusion Criteria:
- one with medical or developmental conditions, i.e. epilepsy, global developmental delay, pervasive learning disorder such as autism, which may additionally impact on auditory or cognitive performance.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Computer-based auditory training (CBAT)
The CBAT programmes in the current study were specifically designed to improve speech-in-noise and dichotic listening skills of children diagnosed with CAPD.
All the training programmes were designed to be installed on home-user's computer, and they were visually attractive and appealing to children.
The development of the software (non commercial) for the speech-in-noise and dichotic listening training was done by two different teams in the United Kingdom and Singapore, respectively.
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There are 3 listening games (i.e. Doggy, Who-Is-Right, Story-in-noise) that target on speech-in-noise training and 1 listening game (i.e. TATP) that aims to train dichotic listening. Patient was required to undergo the training for 30 minutes per day, 5 sessions per week, for a duration of 12 weeks. Parents were advised to keep a journal to record child's training hour of the day. |
No Intervention: Control
No intervention other than participants' regular school activities
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in auditory processing skills at 3 months
Time Frame: baseline, and post-3 months
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The auditory processing skills of patients were assessed using the LiSN-S.
The LiSN-S is an auditory task that assesses the ability of children to understand speech in the background of two other talkers.
The LiSN-S test was administered using a laptop with a circumaural headphones connected to the computer.
The target sentences were presented at an initial level of 62 dB SPL, whereas the distracter stories were presented at a constant level of 55 dB SPL.
The target stimuli and distracter discourse were presented to both ears simultaneously.
A maximum of 30 sentences were presented in each of the four listening conditions.
The patient was required to repeat the targeted sentences verbally in every listening condition and correct responses were scored manually by the me on the computer.
The stimulus presentation level was adjusted adaptively depending on the patient's response.
The assessment took approximately 20 minutes to complete.
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baseline, and post-3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in listening skills at 3 months
Time Frame: Baseline, and post-3 months
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The listening skills of patients were assessed using two questionnaires: a) Pragmatic Profile (PP) questionnaire consisted of 52 items concerning the rituals and conversational skills of a child, how a child asks for information and gives responses, and nonverbal communication skills; b) The CHAPS questionnaire consisted of 36 questions evaluating a child's listening skills in 6 different auditory conditions (noise, quiet, ideal, multiple inputs, auditory memory sequencing, and auditory attention span) in comparison to his/her peers.
The PP and CHAPS questionnaire was completed by each patient's parents and teacher respectively.
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Baseline, and post-3 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Jenny HY Loo, PhD, National University Health System
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- 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
- Disease
- Language Development Disorders
- Auditory Perceptual Disorders
Other Study ID Numbers
- D/09/485
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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