- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02525640
Hearing Handicap in Patients With Single Sided Deafness
Single sided deafness (SSD) refers to asymmetrical hearing loss, where there is a significant worsening of hearing in one ear compared to the other.
In Cambridge, the investigators see large numbers of patients with SSD caused by vestibular schwannomas, due to their affiliation with the Neuro-Otology Department, with over 100 new SSD patients being referred every year.
Only a small number of studies have explored hearing handicap for those with SSD, and music appreciation has not been investigated, to the best of the investigators knowledge, in this patient group.
In the limited number of studies conducted on those with single sided deafness, often only one or two outcome measures have been used, or the patient group has been small. The investigators have a large group of patients with a wide range of aetiologies who have completed several questionnaires as part of their treatment in the single sided deafness clinic and the investigators would like to analyse these data.
At present there are different devices available on the NHS for the management of SSD and many studies have explored benefits of Bone Anchored Hearing Aids (BAHA). There is an under-representation of studies looking specifically at CROS aid devices which is relevant given the cost differences involved between devices.
Study goals and objectives
- To find out what factors drive hearing handicap in SSD patients by analysing the results of several different well validated hearing handicap questionnaires
- To find out whether or not it is possible to change hearing handicap in this patient group by looking to see if there is an improvement in questionnaire scores post treatment.
- The investigators will also look at a sub-group who will be fitted with both traditional wired CROS aids and more up-to-date wireless aids which have been funded through a research grant, in order to assess whether these are more beneficial.
- The investigators will use a new questionnaire developed in-house to further explore the impact of single sided deafness on music appreciation.
Study Overview
Detailed Description
SSD can lead to:
- Reduction in spatial hearing
- Significant difficulty in background noise and social situations
- Exhaustion from the extra effort required to hear
- Reduced confidence
- Reduced ability to enjoy music
- Isolation
- An emotional burden linked to the onset of the hearing loss and associated symptoms
The investigators have established a specialised clinic to address the consequences of SSD, and assess treatment options including the provision of counselling and wired CROS (Contralateral Routing of Signal) hearing aids.
The investigators use a range of questionnaires, completed pre and post treatment, to assess outcomes and would like to analyse this data to see what drives handicap and whether there is any observable improvement post treatment. The investigators would like to find out more about the impact of SSD on patients' ability to enjoy music and propose to do this using a questionnaire developed in-house.
The investigators have been awarded a grant to fit some of their patients with wireless CROS aids, which are not routinely available under the NHS in Cambridge, but are widely available in other areas and in the commercial sector.
The investigators will utilise retrospective data in the form of questionnaires completed by SSD patients attending the Audiology clinic between 2009 and 2012. Prospective data will also be collected and from existing SSD patients, to whom the investigators intend to post the music appreciation questionnaire, or ask them to complete in clinic.
A prospective cross over design study will compare wired and wireless CROS hearing aids in 13 new patients a cross-over design trial to investigate whether residual handicap and satisfaction are any better with these devices than with standard wired versions.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Cambridgeshire
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Cambridge, Cambridgeshire, United Kingdom, CB7 5TT
- Cambridge University Hospital NHS Trust, Audiology department
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients who attend the single sided deafness clinic.
- Must have either no recordable hearing threshold levels on one side or a significant asymmetry.
- The 13 CROS aid trial patients must be post-operative vestibular schwannoma patients with an audiological 'dead ear' on the affected side.
Exclusion Criteria:
- Patients unable to give informed consent
- Patients under 18 years of age
- For the CROS aid trial, patients with any aetiology other than vestibular schwanomma, pre-operative vestibular schwanomma patients or vestibular schwanomma patents who still have residual hearing in the affected ear.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Hearing Aid
CROS hearing aid
|
Hearing aid comparison
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Abbreviated hearing aid benefit profile (APHAB)
Time Frame: 180 days
|
Hearing aid benefit questionnaire
|
180 days
|
Speech and spatial qualities of hearing (SSQ)
Time Frame: 180 days
|
Hearing aid benefit questionnaire
|
180 days
|
Tinnitus handicap inventory (THI)
Time Frame: 180 days
|
Tinnitus questionnaire
|
180 days
|
Hearing handicap inventory (HHI)
Time Frame: 180 days
|
Hearing aid benefit questionnaire
|
180 days
|
Hospital anxiety and depression scale (HADS)
Time Frame: 180 days
|
Anxiety and depression questionnaire
|
180 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mark D Smith, MSc, Addenbrooke's Hospital, Cambridge, UK
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 108402
- A092833 (OTHER: Addenbrookes Hospital, Cambridge)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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