Comparison of BAHA Softband vs conventional hearing aid in management of hearing loss in young children with Down's syndrome
| ISRCTN | ISRCTN05610852 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN05610852 |
| Secondary identifying numbers | N0155164513 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 30/08/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr P Sheehan
Scientific
Scientific
ENT Department
North Manchester General Hospital
Delaunays Road
Manchester
M8 5RB
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | Is BAHA Softband better than conventional hearing aid for children with Down's Syndrome? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Ear, Nose and Throat: Hearing loss |
| Intervention | BAHA Softband vs conventional hearing aid |
| Intervention type | Other |
| Primary outcome measure | Improvement in hearing |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 31/05/2005 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 24 Months |
| Upper age limit | 48 Months |
| Sex | Not Specified |
| Target number of participants | 16 |
| Key inclusion criteria | Children with Down's Syndrome aged 24-48 months with mild to moderate hearing loss. |
| Key exclusion criteria | Severe hearing loss. |
| Date of first enrolment | 31/05/2005 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
ENT Department
Manchester
M8 5RB
United Kingdom
M8 5RB
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Pennine Acute Hospitals NHS Trust (UK), Own Account, NHS R&D Support Funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
