Bone Conduction DeafnessNCT03766152
Audiological Benefit and Improved Quality of Life With Two Bone Conduction Systems: ADHEAR vs. Bonebridge in Experienced Users
A study testing Adhesive bone conduction hearing aid (ADHEAR - Med El) in people with Bone Conduction Deafness and Hearing Loss, Conductive, run by Dominik Riss at 1 site in Austria.
Trial summary
Patients implanted with a Bonebridge will be asked to be part of the study. The study subjects are enrolled into the study according to inclusion criteria. Patients will be asked to wear an adhesive bone conduction device an adapt to it for 30-60 min. Read more about this study
- Who is it for?
- Ages 13 to 99 years
- Conditions the study is for
- Bone Conduction Deafness, Hearing Loss, Conductive
- What is being tested?
- Adhesive bone conduction hearing aid (ADHEAR - Med El)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteAustria
- Study dates
- 1 Nov 2018to 13 Dec 2019
- 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 13 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients implanted with a Bonebridge device and are active users
- Unilateral and/or bilateral conductive hearing loss (CHL)
- Subjects aged 13 years or older
- Capable of the German language
- Willingness and ability to perform all tests required for the study
- Signed, and dated informed consent before the start of any study specific procedure
Who cannot join
- Pregnancy or breastfeeding
- Patient is intolerant of the materials as described by Manufacturer's IFU
- Patient presents with a skin or scalp condition that may preclude the attachment of the adhesive adapter.
- Patient cannot perform the audiological tests or is unable to fill out the questionnaires.
- Patient presents with retrocochlear, or central auditory disorder.
- any physical, psychological, or emotional disorder that would interfere with the ability to perform on test and rehabilitation procedures
Trial locations and contacts
1 site in 1 country.
About this study
Patients implanted with a Bonebridge will be asked to be part of the study. The study subjects are enrolled into the study according to inclusion criteria.
Patients will be asked to wear an adhesive bone conduction device an adapt to it for 30-60 min. After this time period patients will be asked to use the adhesive device instead of the Bonebridge for 3 weeks. Audiologic Tests and quality of life questionnaires will be assessed at the beginning of the study and at the end of three weeks.
Read the detailed description
Phase 1 Patients will be fitted with an adhesive bone conduction device and asked to fill out two questionnaires. They will then wear the device for 30-60 minutes and decide if they want to wear the device for the remaining study time of three weeks. Patients who do not have sufficient benefit from the device or do not feel comfortable with it do not enter the second study period of wearing the device for three weeks. Patients will be asked to comment on their experiences after 30 to 60 minutes explaining why they do not want to enter the second part of the study if they feel comfortable sharing this information. Phase 2 Patients, in the second study period, will be asked to wear the hearing device as long as comfortable to them every day and mark time of device usage, battery life, changes of the adhesive adapter, sound quality and comfort related remarks in a diary. After three weeks patients will return to the outpatient ́s department for an audiological assessment and a second set of quality of hearing and quality of life questionnaire.
No patients will be implanted with a Bonebridge as part of the study.
Audiologic testing consists of sound field audiometry, Freiburg monosyllables test and Oldenburg sentence test.
Questionnaires consist of the AQol-8D and the SSQ-12
- Conditions
- Bone Conduction Deafness, Hearing Loss, Conductive
- Being tested
- Adhesive bone conduction hearing aid (ADHEAR - Med El)
- Keywords
- Hearing aid
- 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.
Adhesive bone conduction hearing aid (ADHEAR - Med El)Device
Patients are asked to wear an adhesive bone conduction hearing device which is attached to the mastoid with an adhesive adapter
| Study group | Role | What they receive |
|---|---|---|
| Adhear | Other | Patients will be fitted with an adhesive bone conduction device for three weeks Receives: Device: Adhesive bone conduction hearing aid (ADHEAR - Med El) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average functional hearing gain
The primary endpoint of the study is the average functional hearing gain evaluated by the free field audiometry (at 4 different frequencies) using the bone conduction device compared to the unaided situation. To compare the two hearing devices the following primary endpoint measure will be calculated: Δmean= {(Average functional hearing gain with Bonebridge - Average functional hearing gain with ADHEAR at timepoint T1 (=Δ1)) + (Average functional hearing gain with Bonebridge - Average functional hearing gain with ADHEAR at timepoint T2 (=Δ2))} divided by two. Measuring both hearing devices at both timepoints and using the mean difference (Δmean) enables adjustment for a possible underlying customization effect.
Measured: 3 weeks
Secondary outcomes (4)
AQoL-8D (quality of life)
Will be measured by comparing Quality of Life as assessed with AQoL - 8D at the beginning of the study and the end of the study (The result of the AQoL-8D is a number)
Measured: 3 weeks
Quality of hearing
Quality of hearing as assessed with the SSQ 12 questionnaire will be compared at the beginning of the study to the results after the three weeks with the adhesive device.
The results of the SSQ-12 is a number
Measured: 3 weeks
Word recognition score
Further secondary outcomes will be assessed by comparing the results of the word recognition test in the aided condition once with the implanted device (Bonebridge) in comparison to the adhesive device (ADHEAR). Word recognition is measured in percent at two different noise levels
Measured: 3 weeks
Sentence test
Further secondary outcomes will be assessed by comparing the results of the sentence test in the aided condition once with the implanted device (Bonebridge) in comparison to the adhesive device (ADHEAR). Sentence test results are measured as percent at a certain volume level (dB).
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start1 Nov 2018
- Primary completion31 Oct 2019
- Study completion13 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Conduction DeafnessStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dominik Riss
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dominik Riss, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766152
- Sponsor's protocol ID
- 1757/2018
- Status last verified
- Dec 2019
- First submitted
- 16 Nov 2018
- Last updated
- 2 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Audiological Benefit and Improved Quality of Life With Two Bone Conduction Systems: ADHEAR vs. Bonebridge in Experienced Users
- ClinicalTrials.gov ID
- NCT03766152
- Acronym / sponsor ID
- 1757/2018
- Conditions
- Bone Conduction Deafness, Hearing Loss, Conductive
- Keywords
- Hearing aid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Dominik RissUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 13 Dec 2019 (actual)
- First posted
- 6 Dec 2018 (actual)
- 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.
Patients implanted with a Bonebridge will be asked to be part of the study. The study subjects are enrolled into the study according to inclusion criteria.
Patients will be asked to wear an adhesive bone conduction device an adapt to it for 30-60 min. After this time period patients will be asked to use the adhesive device instead of the Bonebridge for 3 weeks. Audiologic Tests and quality of life questionnaires will be assessed at the beginning of the study and at the end of three weeks.
Detailed description
Phase 1 Patients will be fitted with an adhesive bone conduction device and asked to fill out two questionnaires. They will then wear the device for 30-60 minutes and decide if they want to wear the device for the remaining study time of three weeks. Patients who do not have sufficient benefit from the device or do not feel comfortable with it do not enter the second study period of wearing the device for three weeks. Patients will be asked to comment on their experiences after 30 to 60 minutes explaining why they do not want to enter the second part of the study if they feel comfortable sharing this information. Phase 2 Patients, in the second study period, will be asked to wear the hearing device as long as comfortable to them every day and mark time of device usage, battery life, changes of the adhesive adapter, sound quality and comfort related remarks in a diary. After three weeks patients will return to the outpatient ́s department for an audiological assessment and a second set of quality of hearing and quality of life questionnaire.
No patients will be implanted with a Bonebridge as part of the study.
Audiologic testing consists of sound field audiometry, Freiburg monosyllables test and Oldenburg sentence test.
Questionnaires consist of the AQol-8D and the SSQ-12
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adhear | Other | Device: Adhesive bone conduction hearing aid (ADHEAR - Med El)Patients will be fitted with an adhesive bone conduction device for three weeks |
Who may qualify
- Ages
- 13 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients implanted with a Bonebridge device and are active users
- Unilateral and/or bilateral conductive hearing loss (CHL)
- Subjects aged 13 years or older
- Capable of the German language
- Willingness and ability to perform all tests required for the study
Key exclusion criteria (6 listed)
- Pregnancy or breastfeeding
- Patient is intolerant of the materials as described by Manufacturer's IFU
- Patient presents with a skin or scalp condition that may preclude the attachment of the adhesive adapter.
- Patient cannot perform the audiological tests or is unable to fill out the questionnaires.
- Patient presents with retrocochlear, or central auditory disorder.
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 |
|---|---|---|
| Adhesive bone conduction hearing aid (ADHEAR - Med El)Patients are asked to wear an adhesive bone conduction hearing device which is attached to the mastoid with an adhesive adapter | Device | Adhear |
Primary outcome
Average functional hearing gain
Time frame: 3 weeks
The primary endpoint of the study is the average functional hearing gain evaluated by the free field audiometry (at 4 different frequencies) using the bone conduction device compared to the unaided situation. To compare the two hearing devices the following primary endpoint measure will be calculated: Δmean= {(Average functional hearing gain with Bonebridge - Average functional hearing gain with ADHEAR at timepoint T1 (=Δ1)) + (Average functional hearing gain with Bonebridge - Average functional hearing gain with ADHEAR at timepoint T2 (=Δ2))} divided by two. Measuring both hearing devices at both timepoints and using the mean difference (Δmean) enables adjustment for a possible underlying customization effect.
4 secondary outcomes
AQoL-8D (quality of life)
Time frame: 3 weeks
Quality of hearing
Time frame: 3 weeks
Word recognition score
Time frame: 3 weeks
Sentence test
Time frame: 3 weeks
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 2 Jan 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adhesive bone conduction hearing aid (ADHEAR - Med El) in people with Bone Conduction Deafness and Hearing Loss, Conductive, run by Dominik Riss at 1 site in Austria.
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 6 inclusion and 6 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 2 Jan 2020. 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 Austria. 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?
Average functional hearing gain (time frame: 3 weeks). 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 2 Jan 2020.