Hearing Handicap in Patients With Single Sided Deafness
Primary Purpose
Hearing Loss
Status
Withdrawn
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Hearing Aid
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss focused on measuring Single sided hearing loss, Single sided deafness, Hearing loss music appreciation
Eligibility Criteria
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.
Sites / Locations
- Cambridge University Hospital NHS Trust, Audiology department
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hearing Aid
Arm Description
CROS hearing aid
Outcomes
Primary Outcome Measures
Abbreviated hearing aid benefit profile (APHAB)
Hearing aid benefit questionnaire
Speech and spatial qualities of hearing (SSQ)
Hearing aid benefit questionnaire
Tinnitus handicap inventory (THI)
Tinnitus questionnaire
Hearing handicap inventory (HHI)
Hearing aid benefit questionnaire
Hospital anxiety and depression scale (HADS)
Anxiety and depression questionnaire
Secondary Outcome Measures
Full Information
NCT ID
NCT02525640
First Posted
September 3, 2014
Last Updated
April 6, 2017
Sponsor
Cambridge University Hospitals NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT02525640
Brief Title
Hearing Handicap in Patients With Single Sided Deafness
Official Title
Hearing Handicap in Patients With Single Sided Deafness
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Withdrawn
Why Stopped
No participants recrui
Study Start Date
August 1, 2015 (Anticipated)
Primary Completion Date
February 1, 2017 (Actual)
Study Completion Date
February 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cambridge University Hospitals NHS Foundation Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
Single sided hearing loss, Single sided deafness, Hearing loss music appreciation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hearing Aid
Arm Type
Experimental
Arm Description
CROS hearing aid
Intervention Type
Device
Intervention Name(s)
Hearing Aid
Other Intervention Name(s)
Phonak Nathos S+ Micro Wireless CROS aid, Oticon Spirit Zest Wired CROS aid
Intervention Description
Hearing aid comparison
Primary Outcome Measure Information:
Title
Abbreviated hearing aid benefit profile (APHAB)
Description
Hearing aid benefit questionnaire
Time Frame
180 days
Title
Speech and spatial qualities of hearing (SSQ)
Description
Hearing aid benefit questionnaire
Time Frame
180 days
Title
Tinnitus handicap inventory (THI)
Description
Tinnitus questionnaire
Time Frame
180 days
Title
Hearing handicap inventory (HHI)
Description
Hearing aid benefit questionnaire
Time Frame
180 days
Title
Hospital anxiety and depression scale (HADS)
Description
Anxiety and depression questionnaire
Time Frame
180 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark D Smith, MSc
Organizational Affiliation
Addenbrooke's Hospital, Cambridge, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cambridge University Hospital NHS Trust, Audiology department
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB7 5TT
Country
United Kingdom
12. IPD Sharing Statement
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Hearing Handicap in Patients With Single Sided Deafness
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