Hearing Loss, ConductiveNCT01858246
A Randomised Controlled Trial Comparing Bone Anchored Hearing Aid With Bonebridge
A study testing Bonebridge and Bone Anchored Hearing Aid in people with Hearing Loss, Conductive and Bone Conduction Deafness, run by Ninewells Hospital at 1 site in United Kingdom.
Trial summary
The Bonebridge is a new bone conducting implantable hearing aid. The investigators plan to randomize patients to receive either the Bonebridge or a conventional bone conducting hearing device. The investigators will then compare the surgical and audiological outcomes of the two groups. Read more about this study
- Who is it for?
- Ages 16 to 85 years
- Conditions the study is for
- Hearing Loss, Conductive, Bone Conduction Deafness
- What is being tested?
- Bonebridge and Bone Anchored Hearing Aid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2014to 31 Dec 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 16 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Conductive Hearing Loss within criteria for Bonebridge
- Adults
Who cannot join
- Children
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Ninewells Hospital and Medical School
Dundee, DD1 9SY
About this study
The Bonebridge is a new bone conducting implantable hearing aid. The investigators plan to randomize patients to receive either the Bonebridge or a conventional bone conducting hearing device. The investigators will then compare the surgical and audiological outcomes of the two groups.
Read the detailed description
The new Bonebridge fully implanted, except for an external sound processor. It does not have any percutaneous parts like the Bone Anchored Hearing Aid. The investigators believe that this may improve wound healing and reduce problems with wound infection and skin overgrowth seen in Bone Anchored Hearing Aids.
There may also be audiological improvements by the use of the Bonebridge as the physical separation of the vibrating part from the sound processor should reduce feedback. The company also claims other audiological improvements in the Bonebridge.
The investigators wish to demonstrate whether this is actually the case by performing a study directly comparing the outcomes of the two groups.
- Conditions
- Hearing Loss, Conductive, Bone Conduction Deafness
- Being tested
- Bonebridge, Bone Anchored Hearing Aid
- Keywords
- Hearing Loss, Conductive, Bone Conduction, bone conduction thresholds better than 45 dBHL
- Medical subject headings
- Hearing Loss, Conductive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BonebridgeDevice
Bone Anchored Hearing AidDevice
| Study group | Role | What they receive |
|---|---|---|
| Bonebridge | Active comparator | Implantation with a Bonebridge Receives: Device: Bonebridge |
| Bone Anchored Hearing Aid | Active comparator | Implantation with a Bone Anchored Hearing Aid Receives: Device: Bone Anchored Hearing Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech audiogram result at 6 months after switch on at 60 dBA in quiet using AB word lists
We will record and compare the standard speech audiometry results at a specific sound level in order to make a direct comparison of devices
Measured: Up to 1 year post-operatively
Secondary outcomes (5)
Speech audiogram result at 60 dB A in noise using AB word lists
The speech audiogram will also be carried out in noise to demonstrate whether one device gives an appreciable advantage over another with respect to understanding in noise compared to silence.
Measured: Up to 1 year after implantation
Patient reported outcome data
Patients will be asked to complete the Glasgow Benefit Inventory (GBI) and Hearing Device Satisfaction Scale (HDSS) questionnaires
Measured: Up to 1 year following implantation
Time from surgery to device switch-on
The time (measured in days) will be recorded from the date of implantation to the date of its switch-on.
Measured: Up to 3 months
Number of patient episodes required during study period
Measured: 1 year from implantation
Time to complete wound healing
Measured in days, as judged subjectively by ENT medical and nursing staff
Measured: Up to 3 months from implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startJan 2014
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, ConductiveStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ninewells Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Jones, Ninewells Hospital
- Investigators
- Stephen EM Jones, Principal investigator, NHS Tayside
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01858246
- Sponsor's protocol ID
- SJPSMH01
- Status last verified
- Jan 2018
- First submitted
- 15 May 2013
- Last updated
- 24 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial Comparing Bone Anchored Hearing Aid With Bonebridge
- ClinicalTrials.gov ID
- NCT01858246
- Acronym / sponsor ID
- SJPSMH01
- Conditions
- Hearing Loss, Conductive, Bone Conduction Deafness
- Keywords
- Hearing Loss, Conductive, Bone Conduction, bone conduction thresholds better than 45 dBHL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Ninewells HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 21 May 2013 (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.
The Bonebridge is a new bone conducting implantable hearing aid. The investigators plan to randomize patients to receive either the Bonebridge or a conventional bone conducting hearing device. The investigators will then compare the surgical and audiological outcomes of the two groups.
Detailed description
The new Bonebridge fully implanted, except for an external sound processor. It does not have any percutaneous parts like the Bone Anchored Hearing Aid. The investigators believe that this may improve wound healing and reduce problems with wound infection and skin overgrowth seen in Bone Anchored Hearing Aids.
There may also be audiological improvements by the use of the Bonebridge as the physical separation of the vibrating part from the sound processor should reduce feedback. The company also claims other audiological improvements in the Bonebridge.
The investigators wish to demonstrate whether this is actually the case by performing a study directly comparing the outcomes of the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bonebridge | Active comparator | Device: BonebridgeImplantation with a Bonebridge |
| Bone Anchored Hearing Aid | Active comparator | Device: Bone Anchored Hearing AidImplantation with a Bone Anchored Hearing Aid |
Who may qualify
- Ages
- 16 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Conductive Hearing Loss within criteria for Bonebridge
- Adults
Key exclusion criteria (2 listed)
- Children
- Pregnancy
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 |
|---|---|---|
| Bonebridge | Device | Bonebridge |
| Bone Anchored Hearing Aid | Device | Bone Anchored Hearing Aid |
Primary outcome
Speech audiogram result at 6 months after switch on at 60 dBA in quiet using AB word lists
Time frame: Up to 1 year post-operatively
We will record and compare the standard speech audiometry results at a specific sound level in order to make a direct comparison of devices
5 secondary outcomes
Speech audiogram result at 60 dB A in noise using AB word lists
Time frame: Up to 1 year after implantation
Patient reported outcome data
Time frame: Up to 1 year following implantation
Time from surgery to device switch-on
Time frame: Up to 3 months
Number of patient episodes required during study period
Time frame: 1 year from implantation
Time to complete wound healing
Time frame: Up to 3 months from implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2018.
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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.
Stephen EM Jones principal investigator
NHS Tayside
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bonebridge and Bone Anchored Hearing Aid in people with Hearing Loss, Conductive and Bone Conduction Deafness, run by Ninewells Hospital 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 24 Jan 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Speech audiogram result at 6 months after switch on at 60 dBA in quiet using AB word lists (time frame: Up to 1 year post-operatively). 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 24 Jan 2018.