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 |
| Protocol serial number | N0155164513 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funder | Pennine Acute Hospitals NHS Trust (UK), Own Account, NHS R&D Support Funding |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) | Improvement in hearing |
| Key secondary outcome measure(s) | Not provided at time of registration |
| 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 sample size at registration | 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
- United Kingdom
- England
Study participating centre
ENT Department
Manchester
M8 5RB
United Kingdom
M8 5RB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
