Condition category
Ear, Nose and Throat
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
30/08/2012
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

Mr P Sheehan

ORCID ID

Contact details

ENT Department
North Manchester General Hospital
Delaunays Road
Manchester
M8 5RB
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0155164513

Study information

Scientific title

Acronym

Study hypothesis

Is BAHA Softband better than conventional hearing aid for children with Down's Syndrome?

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

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Ear, Nose and Throat: Hearing loss

Intervention

BAHA Softband vs conventional hearing aid

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Improvement in hearing

Secondary outcome measures

Not provided at time of registration

Overall trial start date

31/05/2005

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Children with Down's Syndrome aged 24-48 months with mild to moderate hearing loss.

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

16

Participant exclusion criteria

Severe hearing loss.

Recruitment start date

31/05/2005

Recruitment end date

31/12/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

ENT Department
Manchester
M8 5RB
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

Pennine Acute Hospitals NHS Trust (UK), Own Account, 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