Condition category
Signs and Symptoms
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
13/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nasreen Islam

ORCID ID

Contact details

Barnet & Chase Farm Hospitals NHS Trust
Chase Farm Hospital
The Ridgeway
Enfield
EN2 8JL
United Kingdom

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes