Hearing LossNCT04578457
Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2020_09
A study testing Hearing Aid without NR enabled, Hearing Aid with NR(1) and Hearing Aid with NR(2) in people with Hearing Loss, run by Sonova AG at 1 site in Switzerland.
Trial summary
Participants will perform two different listening tasks: (1) listening to, and repeating back, sentence lists presented in noise, and (2) Subjective rating of effort \& performance following each condition. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Hearing Aid without NR enabled, Hearing Aid with NR(1) and Hearing Aid with NR(2)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSwitzerland
- Study dates
- 23 Oct 2020to 22 Apr 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- 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
- Minimum 1 year hearing aid experience
- Moderate-Severe (N3-N5) hearing loss or Normal Hearing
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
- 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
Participants will perform two different listening tasks: (1) listening to, and repeating back, sentence lists presented in noise, and (2) Subjective rating of effort \& performance following each condition. During this study, continuous, non-invasive physiological measurements (skin conductance, changes in pupil dilation) will be recorded from participants. Using this paradigm we will be assessing the effect of different hearing aid processing algorithms on listening effort. The study takes the form of a one factor (algorithm), within-subjects design.
Each participant performs the Speech perception task with each algorithm (reference, noise reduction I, noise reduction II, noise reduction III), at two individualized signal-to-noise ratios (SRT90 and SRT50). Additionally subjective performance ratings in real-life will be collected.
- Conditions
- Hearing Loss
- Being tested
- Hearing Aid without NR enabled, Hearing Aid with NR(1), Hearing Aid with NR(2), Hearing Aid with NR(3)
- 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 enabledDevice
Each participant will be fitted with noise reduction disabled. Disabled means that no sound processing algorithm that removes noise from the speech signal is active.
Hearing Aid with NR(1)Device
Each participant will be fitted with the noise reduction program on the same hearing aid. The principle of the noise reduction algorithm is to remove noise from a speech signal with the aim of improving the speech intelligibility and comfort.
Hearing Aid with NR(2)Device
Each participant will be fitted with a second noise reduction program on the same hearing aid. The parameterization of this NR algorithm differs from that in NR(1).
Hearing Aid with NR(3)Device
Each participant will be fitted with a third noise reduction program on the same hearing aid. The parameterization of this NR algorithm differs from that in NR(1) and NR(2).
| Study group | Role | What they receive |
|---|---|---|
| Hearing Aid without NR(0) enabled | Active comparator | Hearing Aid without Noise Reduction (NR 0) enabled serves as reference condition. Receives: Device: Hearing Aid without NR enabled |
| Hearing Aid with NR (1) | Experimental | Hearing Aid with Noise Reduction I (NR) enabled. Receives: Device: Hearing Aid with NR(1) |
| Hearing Aid with NR(2) | Experimental | Hearing Aid with Noise Reduction II (NR) enabled. Receives: Device: Hearing Aid with NR(2) |
| Hearing Aid with NR(3) | Experimental | Hearing Aid with Noise Reduction III (NR) enabled. Receives: Device: Hearing Aid with NR(3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in Event-related-skin-conductance
Skin conductance will be recorded from participants during the performance of the auditory task. Analyses will be carried out on the skin conductance response recorded during a time window following each auditory stimulus. It is planned to analyze event-related skin conductance response amplitudes \& latencies (micro-Siemens \& milliseconds).
Measured: 6 weeks
Differences in Event-related-pupil-dilation (ERPDs)
Pupil dilations will be recorded from the participant during the performance of the auditory tasks.
Analyses will be carried out relative to the pre-trial baseline (measured one second prior to the onset of the stimulus), in order to account for differences in baseline physiological activity.
It is planned to analyze event-related-pupil-dilations. We use the unit: pixels. The size of a pixel in 1mm^2 is relative to the distance between the eye and the camera. Even though participants heads were placed on a chin rest that was always the same distance from the camera, the distance between the individual eye and the camera can still be different due to differences in participants' anatomies.
Thus, pupil dilation are often reported relative to an individuals' baseline, for example as percent change relative to the baseline.
Therefore, we use the unit: pixels, as the use of mm^2 may be inaccurate.
Measured: 6 weeks
Secondary outcomes (3)
Oldenburg Sentence Test
Words recalled correctly: words repeated back by participants are logged and the percentage of words recalled correctly calculated.
Measured: 6 weeks
Sound Quality Ratings
The sound quality ratings will be assessed with the aid of a Multi-Stimulus Test.
The data, serving as secondary outcome measure, are collected in the laboratory.
The scale ranges from 0 "very bad" to 6 "very good" in increments of 1. Individual sound quality rating from participants are averaged over 3 different acoustic scenes for each hearing aid program.
Measured: 6 weeks
Spectro-temporal-modulation Detection Thresholds (STM)
Stimuli which contain simultaneous frequency and amplitude modulations of a wide-band noise carrier are presented to the participants.
The depth of the modulations is systematically varied and the individual modulation detection thresholds are recorded as a broadband decibel (dB) value.
For each participant 4 measures were made and averaged to give a mean STM threshold.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start23 Oct 2020
- Primary completion2 Mar 2021
- Study completion22 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonova AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578457
- Sponsor's protocol ID
- Sonova2020_09
- Status last verified
- Aug 2021
- First submitted
- 1 Oct 2020
- Last updated
- 5 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- 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 5 Oct 2021. 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 - 2020_09
- ClinicalTrials.gov ID
- NCT04578457
- Acronym / sponsor ID
- Sonova2020_09
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2020 (actual)
- Primary completion
- 2 Mar 2021 (actual)
- Study completion
- 22 Apr 2021 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Posted 28 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participants will perform two different listening tasks: (1) listening to, and repeating back, sentence lists presented in noise, and (2) Subjective rating of effort \& performance following each condition. During this study, continuous, non-invasive physiological measurements (skin conductance, changes in pupil dilation) will be recorded from participants. Using this paradigm we will be assessing the effect of different hearing aid processing algorithms on listening effort. The study takes the form of a one factor (algorithm), within-subjects design.
Each participant performs the Speech perception task with each algorithm (reference, noise reduction I, noise reduction II, noise reduction III), at two individualized signal-to-noise ratios (SRT90 and SRT50). Additionally subjective performance ratings in real-life will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hearing Aid without NR(0) enabled | Active comparator | Device: Hearing Aid without NR enabledHearing Aid without Noise Reduction (NR 0) enabled serves as reference condition. |
| Hearing Aid with NR (1) | Experimental | Device: Hearing Aid with NR(1)Hearing Aid with Noise Reduction I (NR) enabled. |
| Hearing Aid with NR(2) | Experimental | Device: Hearing Aid with NR(2)Hearing Aid with Noise Reduction II (NR) enabled. |
| Hearing Aid with NR(3) | Experimental | Device: Hearing Aid with NR(3)Hearing Aid with Noise Reduction III (NR) enabled. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy outer ear (without previous surgical procedures)
- Ability to fill in a questionnaire conscientiously
- Informed Consent as documented by signature
- Minimum 1 year hearing aid experience
- Moderate-Severe (N3-N5) hearing loss or Normal Hearing
Key exclusion criteria (6 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
- Inability to produce a reliable hearing test result
- Massively limited dexterity
- Known psychological problems
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 enabledEach participant will be fitted with noise reduction disabled. Disabled means that no sound processing algorithm that removes noise from the speech signal is active. | Device | Hearing Aid without NR(0) enabled |
| Hearing Aid with NR(1)Each participant will be fitted with the noise reduction program on the same hearing aid. The principle of the noise reduction algorithm is to remove noise from a speech signal with the aim of improving the speech intelligibility and comfort. | Device | Hearing Aid with NR (1) |
| Hearing Aid with NR(2)Each participant will be fitted with a second noise reduction program on the same hearing aid. The parameterization of this NR algorithm differs from that in NR(1). | Device | Hearing Aid with NR(2) |
| Hearing Aid with NR(3)Each participant will be fitted with a third noise reduction program on the same hearing aid. The parameterization of this NR algorithm differs from that in NR(1) and NR(2). | Device | Hearing Aid with NR(3) |
Primary outcome
Differences in Event-related-skin-conductance
Time frame: 6 weeks
Skin conductance will be recorded from participants during the performance of the auditory task. Analyses will be carried out on the skin conductance response recorded during a time window following each auditory stimulus. It is planned to analyze event-related skin conductance response amplitudes \& latencies (micro-Siemens \& milliseconds).
Differences in Event-related-pupil-dilation (ERPDs)
Time frame: 6 weeks
Pupil dilations will be recorded from the participant during the performance of the auditory tasks. Analyses will be carried out relative to the pre-trial baseline (measured one second prior to the onset of the stimulus), in order to account for differences in baseline physiological activity. It is planned to analyze event-related-pupil-dilations. We use the unit: pixels. The size of a pixel in 1mm^2 is relative to the distance between the eye and the camera. Even though participants heads were placed on a chin rest that was always the same distance from the camera, the distance between the individual eye and the camera can still be different due to differences in participants' anatomies. Thus, pupil dilation are often reported relative to an individuals' baseline, for example as percent change relative to the baseline. Therefore, we use the unit: pixels, as the use of mm^2 may be inaccurate.
3 secondary outcomes
Oldenburg Sentence Test
Time frame: 6 weeks
Sound Quality Ratings
Time frame: 6 weeks
Spectro-temporal-modulation Detection Thresholds (STM)
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 Hearing Aid without NR enabled, Hearing Aid with NR(1) and Hearing Aid with NR(2) in people with Hearing Loss, 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 5 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 5 Oct 2021. 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?
Yes. Results are posted in the registry (first posted 28 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Differences in Event-related-skin-conductance (time frame: 6 weeks). The study lists 2 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 5 Oct 2021.