Conductive Hearing LossNCT03746548
Audiological Benefit and Quality of Life With Two Bone Conduction Systems: ADHEAR vs. Contact Mini
A study testing Adhear and Contact Mini (CM) in people with Conductive Hearing Loss, run by Dominik Riss at 1 site in Austria.
Trial summary
Patients with conductive hearing loss fitting the inclusion criteria will be asked to participate in the study. All subjects will be randomized to wear either first the adhesive or the conventional bone conduction hearing aid. They will wear either device for two weeks. Read more about this study
- Who is it for?
- Ages 13 to 99 years
- Conditions the study is for
- Conductive Hearing Loss
- What is being tested?
- Adhear and Contact Mini (CM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jan 2018to 30 Jun 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
- Unilateral and/or bilateral conductive hearing loss (CHL)
- The bone conduction threshold for the patient's affected ear shall be better than or equal to 25 dB HL (PTA BC for 0.5, 1, 2, 3 kHz).
- 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 with conductive hearing loss fitting the inclusion criteria will be asked to participate in the study. All subjects will be randomized to wear either first the adhesive or the conventional bone conduction hearing aid. They will wear either device for two weeks. They will use the second device for another two weeks. Audiologic tests and quality of life questionnaires will be assessed at the beginning of the study after two weeks with the first device and after two weeks with the second device. Additionally, all patients will be asked to keep a diary including daily wearing time of the device.
Read the detailed description
The primary objective of this study is to show, that the ADHEAR will be worn ~75%(~11 to 15 hours per day) of the waking hours, whereas the Contact Mini will be worn ~ 50% (~5 - 8 hours per day) of the waking hours (p<0.05). The authors expect this difference due to increased wearing comfort, reduced/no pressure to the skin of the ADHEAR. The primary objective will be assessed with the diary patients are asked to use.
Audiologic testing will consist of free field audiometry, Freiburger monosyllables test and Oldenburg sentence test. All tests will be performed with and without the devices.
Quality of life and hearing related questionnaires will consist of the AQoL-8D and the SSQ12.
- Conditions
- Conductive Hearing Loss
- Being tested
- Adhear, Contact Mini (CM)
- 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.
AdhearDevice
Patients are wearing the Adhesive bone conduction hearing device (Adhear) for 2 weeks
Contact Mini (CM)Device
Patients are wearing the Conventional bone conduction hearing device (Contact Mini) for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| CM-ADHEAR | Other | First patients use the Contact Mini (conventional bone conduction device used with a soft band or headband) then ADHEAR (adhesive bone conduction device) Receives: Device: Adhear; Device: Contact Mini (CM) |
| ADHEAR - CM | Other | First patients use ADHEAR (adhesive bone conduction device) then CM (conventional bone conduction device used with a soft band or headband) Receives: Device: Adhear; Device: Contact Mini (CM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wearing time
Wearing time per day of the two devices
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start1 Jan 2018
- Primary completion18 Feb 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conductive 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
- 13 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
- NCT03746548
- Sponsor's protocol ID
- 1573/2017
- Status last verified
- Dec 2019
- First submitted
- 11 Nov 2018
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- 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 Quality of Life With Two Bone Conduction Systems: ADHEAR vs. Contact Mini
- ClinicalTrials.gov ID
- NCT03746548
- Acronym / sponsor ID
- 1573/2017
- Conditions
- Conductive Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Dominik RissUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 18 Feb 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 19 Nov 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 with conductive hearing loss fitting the inclusion criteria will be asked to participate in the study. All subjects will be randomized to wear either first the adhesive or the conventional bone conduction hearing aid. They will wear either device for two weeks. They will use the second device for another two weeks. Audiologic tests and quality of life questionnaires will be assessed at the beginning of the study after two weeks with the first device and after two weeks with the second device. Additionally, all patients will be asked to keep a diary including daily wearing time of the device.
Detailed description
The primary objective of this study is to show, that the ADHEAR will be worn ~75%(~11 to 15 hours per day) of the waking hours, whereas the Contact Mini will be worn ~ 50% (~5 - 8 hours per day) of the waking hours (p<0.05). The authors expect this difference due to increased wearing comfort, reduced/no pressure to the skin of the ADHEAR. The primary objective will be assessed with the diary patients are asked to use.
Audiologic testing will consist of free field audiometry, Freiburger monosyllables test and Oldenburg sentence test. All tests will be performed with and without the devices.
Quality of life and hearing related questionnaires will consist of the AQoL-8D and the SSQ12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CM-ADHEAR | Other | Device: Adhear, Device: Contact Mini (CM)First patients use the Contact Mini (conventional bone conduction device used with a soft band or headband) then ADHEAR (adhesive bone conduction device) |
| ADHEAR - CM | Other | Device: Adhear, Device: Contact Mini (CM)First patients use ADHEAR (adhesive bone conduction device) then CM (conventional bone conduction device used with a soft band or headband) |
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)
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 |
|---|---|---|
| AdhearPatients are wearing the Adhesive bone conduction hearing device (Adhear) for 2 weeks | Device | ADHEAR - CM, CM-ADHEAR |
| Contact Mini (CM)Patients are wearing the Conventional bone conduction hearing device (Contact Mini) for 2 weeks | Device | ADHEAR - CM, CM-ADHEAR |
Primary outcome
Wearing time
Time frame: 1 year
Wearing time per day of the two devices
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 Adhear and Contact Mini (CM) in people with Conductive Hearing Loss, 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?
Wearing time (time frame: 1 year). 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.