NCT02111343

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 11, 2014

Completed
Last Updated

April 11, 2014

Status Verified

April 1, 2014

Enrollment Period

1.9 years

First QC Date

March 25, 2014

Last Update Submit

April 7, 2014

Conditions

Keywords

auditory processing disordercentral auditory processing disorderauditory processingauditory training

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline, and post-3 months

Secondary Outcomes (1)

  • Change from baseline in listening skills at 3 months

    Baseline, and post-3 months

Study Arms (2)

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.

Other: Computer-based auditory training (CBAT)

Control

NO INTERVENTION

No intervention other than participants' regular school activities

Interventions

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.

Computer-based auditory training (CBAT)

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, Singapore, 119074, Singapore

Location

MeSH Terms

Conditions

Language Development DisordersAuditory Perceptual Disorders

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsAuditory Diseases, CentralRetrocochlear DiseasesEar DiseasesOtorhinolaryngologic DiseasesBrain DiseasesCentral Nervous System DiseasesPerceptual DisordersCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Jenny HY Loo, PhD

    National University Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Audiologist

Study Record Dates

First Submitted

March 25, 2014

First Posted

April 11, 2014

Study Start

October 1, 2009

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

April 11, 2014

Record last verified: 2014-04

Locations