Hearing LossNCT02525640
Hearing Handicap in Patients With Single Sided Deafness
A study testing Hearing Aid in people with Hearing Loss, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Hearing Aid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2015to 1 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cambridge University Hospital NHS Trust, Audiology department
Cambridge, Cambridgeshire, CB7 5TT
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Hearing Loss
- Being tested
- Hearing Aid
- Keywords
- Single sided hearing loss, Single sided deafness, Hearing loss music appreciation
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearing AidDevice
Also called Phonak Nathos S+ Micro Wireless CROS aid, Oticon Spirit Zest Wired CROS aid
Hearing aid comparison
| Study group | Role | What they receive |
|---|---|---|
| Hearing Aid | Experimental | CROS hearing aid Receives: Device: Hearing Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abbreviated hearing aid benefit profile (APHAB)
Hearing aid benefit questionnaire
Measured: 180 days
Speech and spatial qualities of hearing (SSQ)
Hearing aid benefit questionnaire
Measured: 180 days
Tinnitus handicap inventory (THI)
Tinnitus questionnaire
Measured: 180 days
Hearing handicap inventory (HHI)
Hearing aid benefit questionnaire
Measured: 180 days
Hospital anxiety and depression scale (HADS)
Anxiety and depression questionnaire
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study start1 Aug 2015 (estimated)
- Primary completion1 Feb 2017
- Study completion1 Feb 2017
Why it stopped: No participants recrui
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachel Knappett, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Mark D Smith, MSc, Principal investigator, Addenbrooke's Hospital, Cambridge, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02525640
- Sponsor's protocol ID
- 108402
- Other IDs
- A092833
- Status last verified
- Apr 2017
- First submitted
- 3 Sep 2014
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hearing Handicap in Patients With Single Sided Deafness
- ClinicalTrials.gov ID
- NCT02525640
- Acronym / sponsor ID
- 108402
- Conditions
- Hearing Loss
- Keywords
- Single sided hearing loss, Single sided deafness, Hearing loss music appreciation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants recrui
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Aug 2015 (estimated)
- Primary completion
- 1 Feb 2017 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 17 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hearing Aid | Experimental | Device: Hearing AidCROS hearing aid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hearing AidAlso: Phonak Nathos S+ Micro Wireless CROS aid, Oticon Spirit Zest Wired CROS aidHearing aid comparison | Device | Hearing Aid |
Primary outcome
Abbreviated hearing aid benefit profile (APHAB)
Time frame: 180 days
Hearing aid benefit questionnaire
Speech and spatial qualities of hearing (SSQ)
Time frame: 180 days
Hearing aid benefit questionnaire
Tinnitus handicap inventory (THI)
Time frame: 180 days
Tinnitus questionnaire
Hearing handicap inventory (HHI)
Time frame: 180 days
Hearing aid benefit questionnaire
Hospital anxiety and depression scale (HADS)
Time frame: 180 days
Anxiety and depression questionnaire
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark D Smith, MSc principal investigator
Addenbrooke's Hospital, Cambridge, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hearing Aid in people with Hearing Loss, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abbreviated hearing aid benefit profile (APHAB) (time frame: 180 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2017.