Hearing LossNCT03761927
Physiological, Behavioural and Subjective Measures of Listening Effort
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) listening to short radio excerpts and answering subsequent comprehension 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
- 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
- 17 participants
- Where
- 1 siteSwitzerland
- Study dates
- 8 Oct 2018to 30 Apr 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 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
- 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
Official title: Effect of Noise Reduction Algorithms on Physiological, Behavioural and Subjective Measures of Listening Effort
Participants will perform two different listening tasks: (1) listening to, and repeating back, sentence lists presented in noise, and (2) listening to short radio excerpts and answering subsequent comprehension questions. At the same time participants are required to perform a manual target-tracking task on a touch screen. During this study, continuous, non-invasive physiological measurements (heart rate, skin conductance and hemoencephalography) will be made 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 three factor (listening task x algorithm x signal-to-noise ratio), within-subjects design. Each participant performs each listening task (about 4min long each) with each algorithm (reference, noise reduction I, noise reduction II), at two signal-to-noise ratios (+4 decibel and 0 decibel) twice (test-retest).
- Conditions
- Hearing Loss
- Being tested
- Hearing Aid without NR enabled, Hearing Aid with NR(1), Hearing Aid with NR(2)
- 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).
| Study group | Role | What they receive |
|---|---|---|
| Hearing Aid without NR enabled. | Active comparator | Hearing Aid without Noise Reduction (NR) 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability data
Heart rate variability will be recorded from the participant both before and during the performance of the auditory tasks. Analyses will be carried out relative to the baseline recording (made before the auditory tasks), in order to account for differences in baseline physiological activity. Heart rate variability will be analysed in both the time [ms] and frequency [ms squared] domains.
Measured: 6 weeks
Skin conductance data
Skin conductance will be recorded from the participant both before and during the performance of the auditory tasks. Analyses will be carried out relative to the baseline recording (made before the auditory tasks), in order to account for differences in baseline physiological activity. It is planned to analyse mean levels of skin conductance [micro-Siemens].
Measured: 6 weeks
Secondary outcomes (4)
Hemoencephalography data
Hemoencephalography will be recorded from the participant both before and during the performance of the auditory tasks. Analyses will be carried out relative to the baseline recording (made before the auditory tasks), in order to account for differences in baseline physiological activity. Hemoencephalography will be analysed simply as the ratio of the blue and red light [%] during auditory task performance.
Measured: 6 weeks
Dual-task performance test 1
Performance on the secondary tracking task will be analysed in order to observe whether there is a dual-task cost associated with performing both tasks simultaneously. Typically the level of degradation on the secondary task is thought to reflect an increased listening effort (provided that the primary task performance remains stable). Accordingly, success on the primary task will also be monitored and used in analyses (speech intelligibility in [%] correct). For the Secondary task performance the reaction time [ms] will be analysed.
Measured: 6 weeks
Dual-task performance test 2
Performance on the secondary tracking task will be analysed in order to observe whether there is a dual-task cost associated with performing both tasks simultaneously. Typically the level of degradation on the secondary task is thought to reflect an increased listening effort (provided that the primary task performance remains stable). Accordingly, success on the primary task will also be monitored and used in analyses (comprehension questions [numbers] correct after listening to radio excerpts). For the Secondary task performance the reaction time [ms] will be analysed.
Measured: 6 weeks
Subjective Listening Effort rating
Subjective Listening Effort will also be assessed through self-reported individual listening effort on a 14 point scale from "only noise" to "no effort" after each auditory task.
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 posted3 Dec 2018
- Study start8 Oct 2018
- Primary completion29 Mar 2019
- Study completion30 Apr 2019
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
- 17 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
- NCT03761927
- Sponsor's protocol ID
- Sonova2018_36
- Status last verified
- Jul 2019
- First submitted
- 30 Nov 2018
- Last updated
- 12 Jul 2019
- 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 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Noise Reduction Algorithms on Physiological, Behavioural and Subjective Measures of Listening Effort
- ClinicalTrials.gov ID
- NCT03761927
- Acronym / sponsor ID
- Sonova2018_36
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- 29 Mar 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 3 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.
Participants will perform two different listening tasks: (1) listening to, and repeating back, sentence lists presented in noise, and (2) listening to short radio excerpts and answering subsequent comprehension questions. At the same time participants are required to perform a manual target-tracking task on a touch screen. During this study, continuous, non-invasive physiological measurements (heart rate, skin conductance and hemoencephalography) will be made 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 three factor (listening task x algorithm x signal-to-noise ratio), within-subjects design. Each participant performs each listening task (about 4min long each) with each algorithm (reference, noise reduction I, noise reduction II), at two signal-to-noise ratios (+4 decibel and 0 decibel) twice (test-retest).
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 enabled. | Active comparator | Device: Hearing Aid without NR enabledHearing Aid without Noise Reduction (NR) 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- 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 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) |
Primary outcome
Heart rate variability data
Time frame: 6 weeks
Heart rate variability will be recorded from the participant both before and during the performance of the auditory tasks. Analyses will be carried out relative to the baseline recording (made before the auditory tasks), in order to account for differences in baseline physiological activity. Heart rate variability will be analysed in both the time [ms] and frequency [ms squared] domains.
Skin conductance data
Time frame: 6 weeks
Skin conductance will be recorded from the participant both before and during the performance of the auditory tasks. Analyses will be carried out relative to the baseline recording (made before the auditory tasks), in order to account for differences in baseline physiological activity. It is planned to analyse mean levels of skin conductance [micro-Siemens].
4 secondary outcomes
Hemoencephalography data
Time frame: 6 weeks
Dual-task performance test 1
Time frame: 6 weeks
Dual-task performance test 2
Time frame: 6 weeks
Subjective Listening Effort rating
Time frame: 6 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 12 Jul 2019.
- 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 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 12 Jul 2019. 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?
Heart rate variability data (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 12 Jul 2019.