Hearing LossNCT03578471
Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2018_16
A study testing Hearing Aid without NR and BF, Hearing Aid with NR and Hearing Aid with BF in people with Hearing Loss and Normal Hearing, run by Sonova AG at 1 site in Switzerland.
Trial summary
An EEG study using continuous speech stimuli to assess neural language processing in a hearing impaired population. Participants listen to short radio excerpts in different Signal to Noise Ratios (SNR) and answer comprehension questions as well as listening effort questions. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Normal Hearing
- What is being tested?
- Hearing Aid without NR and BF, Hearing Aid with NR and Hearing Aid with BF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 Jun 2018to 31 Jul 2018
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy outer ear (without previous surgical procedures)
- Ability to fill in a questionnaire conscientiously
- Informed Consent as documented by signature
Who cannot join
- Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
- Limited mobility and not in the position to attend weekly appointments
- Limited ability to describe listening impressions/experiences and the use of the hearing aid
- Inability to produce a reliable hearing test result
- Massively limited dexterity
- Known psychological problems
- Known central hearing disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application
An EEG study using continuous speech stimuli to assess neural language processing in a hearing impaired population. Participants listen to short radio excerpts in different Signal to Noise Ratios (SNR) and answer comprehension questions as well as listening effort questions. We assess the effect of different algorithms on neural language processing as well as subjective listening effort. Each participant hears 12 randomized segments of speech (about 4min long each) with different settings on their hearing aid (reference condition, noise reduction algorithm, beam forming algorithm). This will be a controlled, single blinded and randomized active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarter based in Stäfa.
- Conditions
- Hearing Loss, Normal Hearing
- Being tested
- Hearing Aid without NR and BF, Hearing Aid with NR, Hearing Aid with BF
- 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 Aid without NR and BFDevice
Each participant will be fitted with the Noise Reduction (NR) and Beamforming (BF) disabled. Disabled means that no sound processing algorithm that removes noise from the speech signal is active.
Hearing Aid with NRDevice
Each participant will be fitted with the Noise Reduction (NR)(Sound Changing) program on the same hearing aid. Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The Noise Reduction is working spatially independent.
Hearing Aid with BFDevice
Each participant will be fitted with a beam forming program on the same hearing aid. Beam forming (BF) principle is a sound processing algorithm to remove noise from certain directions to improve the speech intelligibility and comfort.
| Study group | Role | What they receive |
|---|---|---|
| Hearing Aid without NR and BF | Active comparator | Hearing Aid without Noise Reduction (NR) or beam forming (BF) enabled serves as reference condition. Receives: Device: Hearing Aid without NR and BF |
| Hearing Aid with NR | Experimental | Hearing Aid with Noise Reduction (NR) enabled. Receives: Device: Hearing Aid with NR |
| Hearing Aid with BF | Experimental | Hearing Aid with beam forming (BF) enabled. Receives: Device: Hearing Aid with BF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electroencephalogram (EEG) data
Neural language processing will be assessed through the EEG data collected while the participant is listening to running speech (neurophysiological data). Analysis of the brainstem response, cortical entrainment, N400 and alpha power are planned. EEG data is measured in Volt (mV), and entrainment data is analysed through coherence (frequency-based measure of correlation between the acoustic and the neural signal). N400 and alpha power are measured on the variance of mV over time.
Measured: 8 weeks
Secondary outcomes (1)
Subjective Listening Effort rating
The subjective Listening Effort rating will be assessed through self-reported individual listening effort on a scale from "extreme effort" to "no effort".
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start4 Jun 2018
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonova AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Juliane Raether, Principal investigator, Sonova AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578471
- Sponsor's protocol ID
- Sonova2018_16
- Status last verified
- Sep 2018
- First submitted
- 20 Jun 2018
- Last updated
- 18 Sep 2018
- 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 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application
- ClinicalTrials.gov ID
- NCT03578471
- Acronym / sponsor ID
- Sonova2018_16
- Conditions
- Hearing Loss, Normal Hearing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 6 Jul 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.
An EEG study using continuous speech stimuli to assess neural language processing in a hearing impaired population. Participants listen to short radio excerpts in different Signal to Noise Ratios (SNR) and answer comprehension questions as well as listening effort questions. We assess the effect of different algorithms on neural language processing as well as subjective listening effort. Each participant hears 12 randomized segments of speech (about 4min long each) with different settings on their hearing aid (reference condition, noise reduction algorithm, beam forming algorithm). This will be a controlled, single blinded and randomized active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarter based in Stäfa.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hearing Aid without NR and BF | Active comparator | Device: Hearing Aid without NR and BFHearing Aid without Noise Reduction (NR) or beam forming (BF) enabled serves as reference condition. |
| Hearing Aid with NR | Experimental | Device: Hearing Aid with NRHearing Aid with Noise Reduction (NR) enabled. |
| Hearing Aid with BF | Experimental | Device: Hearing Aid with BFHearing Aid with beam forming (BF) enabled. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy outer ear (without previous surgical procedures)
- Ability to fill in a questionnaire conscientiously
- Informed Consent as documented by signature
Key exclusion criteria (7 listed)
- Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
- Limited mobility and not in the position to attend weekly appointments
- Limited ability to describe listening impressions/experiences and the use of the hearing aid
- Inability to produce a reliable hearing test result
- Massively limited dexterity
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 Aid without NR and BFEach participant will be fitted with the Noise Reduction (NR) and Beamforming (BF) disabled. Disabled means that no sound processing algorithm that removes noise from the speech signal is active. | Device | Hearing Aid without NR and BF |
| Hearing Aid with NREach participant will be fitted with the Noise Reduction (NR)(Sound Changing) program on the same hearing aid. Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The Noise Reduction is working spatially independent. | Device | Hearing Aid with NR |
| Hearing Aid with BFEach participant will be fitted with a beam forming program on the same hearing aid. Beam forming (BF) principle is a sound processing algorithm to remove noise from certain directions to improve the speech intelligibility and comfort. | Device | Hearing Aid with BF |
Primary outcome
Electroencephalogram (EEG) data
Time frame: 8 weeks
Neural language processing will be assessed through the EEG data collected while the participant is listening to running speech (neurophysiological data). Analysis of the brainstem response, cortical entrainment, N400 and alpha power are planned. EEG data is measured in Volt (mV), and entrainment data is analysed through coherence (frequency-based measure of correlation between the acoustic and the neural signal). N400 and alpha power are measured on the variance of mV over time.
1 secondary outcome
Subjective Listening Effort rating
Time frame: 8 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 18 Sep 2018.
- 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.
Juliane Raether principal investigator
Sonova AG
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 without NR and BF, Hearing Aid with NR and Hearing Aid with BF in people with Hearing Loss and Normal Hearing, run by Sonova AG at 1 site in Switzerland.
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 7 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 18 Sep 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 Switzerland. 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?
Electroencephalogram (EEG) data (time frame: 8 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 18 Sep 2018.