Central Auditory Processing DisorderCBATNCT02111343
The Effectiveness of Computerized Auditory Training Programme on Children With Auditory Processing Disorder
A study testing Computer-based auditory training (CBAT) in people with Central Auditory Processing Disorder, run by National University Health System, Singapore at 1 site in Singapore.
Trial summary
The current study aimed to examine the effectiveness of a Computer-based auditory training (CBAT) intervention for children with Central Auditory Processing Disorder (CAPD) by comparing the changes in auditory processing (AP) and functional listening skills of these children immediately post-intervention, to that of… Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Central Auditory Processing Disorder
- What is being tested?
- Computer-based auditory training (CBAT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteSingapore
- Study dates
- Oct 2009to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study: The Effectiveness of Computerized Auditory Training Programme on Children With Auditory Processing Disorder
The current study aimed to examine the effectiveness of a Computer-based auditory training (CBAT) intervention for children with Central Auditory Processing Disorder (CAPD) by comparing the changes in auditory processing (AP) and functional listening skills of these children immediately post-intervention, to that of the untrained controls. The AP skills of the trained group were evaluated again at 3 months post-intervention to examine the sustainability of any improvements made from the CBAT intervention. I hypothesised that after intervention, children from the auditory training (AT) group would improve in their AP skills, and that improvement would be greater than the changes in AP skills of those untrained controls. I also hypothesised that the improvement made from the intervention would sustain for at least 3 months after the end of intervention. Finally, I examined if the training outcomes are predictable from any underlying factors such as the initial AP, language, or cognitive skills of these children.
Read the 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).
- Conditions
- Central Auditory Processing Disorder
- Being tested
- Computer-based auditory training (CBAT)
- Keywords
- auditory processing disorder, central auditory processing disorder, auditory processing, auditory training
- Medical subject headings
- Language Development Disorders, Auditory Perceptual Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-based auditory training (CBAT)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Computer-based auditory training (CBAT) | Experimental | 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. Receives: Other: Computer-based auditory training (CBAT) |
| Control | No intervention | No intervention other than participants' regular school activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in auditory processing skills at 3 months
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.
Measured: baseline, and post-3 months
Secondary outcomes (1)
Change from baseline in listening skills at 3 months
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.
Measured: Baseline, and post-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startOct 2009
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Auditory Processing DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Health System, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Jenny Loo, National University Health System, Singapore
- Investigators
- Jenny HY Loo, PhD, Principal investigator, National University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02111343
- Sponsor's protocol ID
- D/09/485
- Acronym
- CBAT
- Status last verified
- Apr 2014
- First submitted
- 25 Mar 2014
- Last updated
- 11 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: The Effectiveness of Computerized Auditory Training Programme on Children With Auditory Processing Disorder
- ClinicalTrials.gov ID
- NCT02111343
- Acronym / sponsor ID
- CBAT / D/09/485
- Conditions
- Central Auditory Processing Disorder
- Keywords
- auditory processing disorder, central auditory processing disorder, auditory processing, auditory training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- National University Health System, SingaporeUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 11 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study aimed to examine the effectiveness of a Computer-based auditory training (CBAT) intervention for children with Central Auditory Processing Disorder (CAPD) by comparing the changes in auditory processing (AP) and functional listening skills of these children immediately post-intervention, to that of the untrained controls. The AP skills of the trained group were evaluated again at 3 months post-intervention to examine the sustainability of any improvements made from the CBAT intervention. I hypothesised that after intervention, children from the auditory training (AT) group would improve in their AP skills, and that improvement would be greater than the changes in AP skills of those untrained controls. I also hypothesised that the improvement made from the intervention would sustain for at least 3 months after the end of intervention. Finally, I examined if the training outcomes are predictable from any underlying factors such as the initial AP, language, or cognitive skills of these children.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computer-based auditory training (CBAT) | Experimental | Other: 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. |
| Control | No intervention | –No intervention other than participants' regular school activities |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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:
- Normal intelligence, as judged by having a nonverbal IQ score of more than 85 (Test of Nonverbal Intelligence, TONI).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer-based auditory training (CBAT)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. | Other | Computer-based auditory training (CBAT) |
Primary outcome
Change from baseline in auditory processing skills at 3 months
Time frame: baseline, and post-3 months
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.
1 secondary outcome
Change from baseline in listening skills at 3 months
Time frame: Baseline, and post-3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jenny HY Loo, PhD principal investigator
National University Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-based auditory training (CBAT) in people with Central Auditory Processing Disorder, run by National University Health System, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in auditory processing skills at 3 months (time frame: baseline, and post-3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2014.