Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0530164776
Study information
Scientific title
Acronym
Study hypothesis
The aim of the study is to establish the observation that children respond at lower speech discrimination thresholds to human voice using the McCormack toy test than when using Automated McCormack toy test.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Diagnostic
Patient information sheet
Condition
Signs and Symptoms: Speech
Intervention
In each centre, all the children will complete both the live and automated voice versions of the toy tests. The order in which the 2 tests are completed will be randomised.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Better understanding of the Clinical Test which is an essential part of normal audiological assessment above the mental age of 2 years.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
04/11/2004
Overall trial end date
03/11/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Maximum of 100 children between 2-4 years. Inclusion criteria:
1. Age 2-4 years (two groups : 2-3 years - Free field audiometry will be used. 3-4 years - Pure tone audiometry) will be used
2. Normal Hearing - Pure tone Audiometry: below 25dBHL, Free field Audiometry: below 30dBA
3. Tympanometry - Type A
4. English must be the first language
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
100
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
04/11/2004
Recruitment end date
03/11/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Barnet & Chase Farm Hospitals NHS Trust
Enfield
EN2 8JL
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
North Central London Research Consortium (UK) NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary