Hearing Loss, BilateralNCT05656313
PRINCE22 System Complete Performance Study
A study testing Measures of speech intelligibility in a noisy situation with speech from the side and from behind (measured with CC-OLSA Test), Measures of the subjective speech recognition threshold in a noisy situation with speech from the side and from behind (measured with HEISS test) and Ability to multitask in the auditory and visual domains in noisy situation with speech from the side and from behind (Multitask test) in people with Hearing Loss, Bilateral and Hearing Loss, Unilateral, run by Sonova AG at 1 site in Germany.
Trial summary
The investigation proposes to compare a narrow reference beamformer to a novel beamformer approach, when the talker is not in front of the hearing aid user and in the presence of background noise. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Bilateral, Hearing Loss, Unilateral
- What is being tested?
- Measures of speech intelligibility in a noisy situation with speech from the side and from behind (measured with CC-OLSA Test), Measures of the subjective speech recognition threshold in a noisy situation with speech from the side and from behind (measured with HEISS test) and Ability to multitask in the auditory and visual domains in noisy situation with speech from the side and from behind (Multitask test)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteGermany
- Study dates
- 3 Nov 2022to 17 Feb 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Experienced (minimum use duration 6 months)
- Adult (minimum age: 18 years) hearing aid users,
- Written and spoken German,
- Ability to understand instruction,
- Ability to perform tests successfully
- Ability to describe listening experiences,
Show all 10Show fewer
- Ability to attend to the appointments,
- Healthy outer ear,
- Moderat to severe Hearing
- Informed consent as documented by signature.
Who cannot join
- Clinical contraindications deformity of the ear (closed ear canal or absence of pinna),
- Known hypersensitivity or allergy,
- Not willing to wear the hearing aid,
- Fluctuating hearing that could influence the results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feature Supporting Multitasking of Visual and Acoustical Objects
The investigation proposes to compare a narrow reference beamformer to a novel beamformer approach, when the talker is not in front of the hearing aid user and in the presence of background noise. The beamformer effect will be determined in terms of speech intelligibility, listening effort and ability to multitask when the talkers are located on the side or in the back.
- Conditions
- Hearing Loss, Bilateral, Hearing Loss, Unilateral
- Being tested
- Measures of speech intelligibility in a noisy situation with speech from the side and from behind (measured with CC-OLSA Test), Measures of the subjective speech recognition threshold in a noisy situation with speech from the side and from behind (measured with HEISS test), Ability to multitask in the auditory and visual domains in noisy situation with speech from the side and from behind (Multitask test), Measure of subjective speech intelligibility and listening effort in noisy situation with speech from the side and from behind (subjective assessment; 100-point scale)
- Medical subject headings
- Hearing Loss, Bilateral, Hearing Loss, Unilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measures of speech intelligibility in a noisy situation with speech from the side and from behind (measured with CC-OLSA Test)Device
The Concurrent OLSA test (CC-OLSA) is a speech recognition test with three turn-taking talkers presenting sentences of the Oldenburg sentences test at fixed signal-to-noise ratios.
CC-OLSA is the only one-talker-at-a-time speech test that is sensitive at the desired SNR and uses sentences with an intelligibility function with slopes of 10-17 %/dB.
Measures of the subjective speech recognition threshold in a noisy situation with speech from the side and from behind (measured with HEISS test)Device
The measure of the subjective speech recognition threshold is an alternative procedure to evaluate the subjective speech intelligibility in different listening conditions. The subjective speech recognition threshold is defined as the speech presentation level of running speech needed to just follow conversation. Subjects have to adjust the presentation level of speech so that they are just able to understand the speech, using a slider on a touch screen. This adjustment is repeated 10 times. Each adjustment results in a value for the subjective speech recognition threshold in dB SNR. The outcome measure is the mean value of the 10 repetitions. The HEISS-Test will be repeated four times for the secondary objective: test for 2 test conditions (Reference, novel approach) against 2 target directions (better ear side, back).
Ability to multitask in the auditory and visual domains in noisy situation with speech from the side and from behind (Multitask test)Device
This test uses a dual-task-paradigm assessing vigilance for auditory and visual triggers concurrently. The primary task is to listen to a novel (Harry Potter) and respond on two trigger words by pressing the appropriate button (one in each hand). The secondary task is to observe a monitor showing a sequence of random signs and respond on a target sign by pressing both buttons. The test includes at least 100 triggers (50 auditory, 50 visual) and takes 10 minutes per condition (side vs. back; novel approach vs. reference; 40 minutes in total). The multitask test will be repeated four times for the secondary objective: 2 conditions (Refrence, novel approach) against 2 target directions (better ear side, back). Following data are provided from each multitask Test measure: (1) subjective rating of the perceived ability to perform the visual and the auditory test simultaneously. (2) reaction times to auditory and visual tasks, and (3) accuracy.
Measure of subjective speech intelligibility and listening effort in noisy situation with speech from the side and from behind (subjective assessment; 100-point scale)Device
In addition to the tests mentioned above a subjective assessment will be used to determine the subjective perception as this measure is often a good indication for clinical relevance.
For this purpose, the same speech material as used in the HEISS-test is presented by a loudspeaker in the same noisy environment as in the other three tests. The subjects rate his/her perception of the presented speech using a questionnaire on the dimensions "listen effort and speech intelligibility". The subject will rate his perception on the 100 point scale with pencils with different colors to get either absolute and relative ratings.
The subjective assessment will be repeated four times for the secondary objective: 2 test conditions (Rference and novel approach) against 2 target directions (better ear side, back). Following data are provided from assessment: rating on a 100-point scale per condition and per dimension.
| Study group | Role | What they receive |
|---|---|---|
| Narrow reference beamformer | Experimental | Not described Receives: Device: Measures of speech intelligibility in a noisy situation with speech from the side and from behind (measured with CC-OLSA Test); Device: Measures of the subjective speech recognition threshold in a noisy situation with speech from the side and from behind (measured with HEISS test); Device: Ability to multitask in the auditory and visual domains in noisy situation with speech from the side and from behind (Multitask test); Device: Measure of subjective speech intelligibility and listening effort in noisy situation with speech from the side and from behind (subjective assessment; 100-point scale) |
| Novel beamformer approach | Active comparator | Not described Receives: Device: Measures of speech intelligibility in a noisy situation with speech from the side and from behind (measured with CC-OLSA Test); Device: Measures of the subjective speech recognition threshold in a noisy situation with speech from the side and from behind (measured with HEISS test); Device: Ability to multitask in the auditory and visual domains in noisy situation with speech from the side and from behind (Multitask test); Device: Measure of subjective speech intelligibility and listening effort in noisy situation with speech from the side and from behind (subjective assessment; 100-point scale) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in speech intelligibility between the reference beamformer and the novel beamformer approach (percentage of correct responses in word recognition) in a noisy situation with speech from the side and from behind.
Two directional conditions (better ear side, back) and two beamformer conditions (Novel approach: SpeechSensor, Reference: StereoZoom) are tested (test and retest, eight measurements in total).
Measured: 4 weeks
Secondary outcomes (3)
Difference in speech recognition threshold between the reference beamformer and the novel (mean value of 10 repetitions).
Subjects have to adjust the presentation level of speech so that they are just able to understand the speech, using a slider on a touch screen. This adjustment is repeated 10 times. Each adjustment results in a value for the subjective speech recognition threshold in dB signal-to-noise ratio.
Measured: 4 weeks
Difference in multitasking ability between the reference beamformer and the novel (1. Respond on two trigger words / 2. Respond on a target sign).
This test uses a dual-task-paradigm assessing vigilance for auditory and visual triggers concurrently. The primary task is to listen to a novel (Harry Potter) and respond on two trigger words by pressing the appropriate button (one in each hand). The secondary task is to observe a monitor showing a sequence of random signs and respond on a target sign by pressing both buttons. The test includes at least 100 triggers (50 auditory, 50 visual) and takes 10 minutes per condition (side vs. back; SpeechSensor vs. StereoZoom; 40 minutes in total).
Measured: 4 weeks
Difference in subjective speech intelligibility between the reference beamformer and the novel (subjects rate his/her perception of the presented speech).
The subjects rate his/her perception of the presented speech using a questionnaire on the dimensions "listen effort and speech intelligibility". The subject will rate his perception on the 100 point scale with pencils with different colors to get either absolute and relative ratings. The subjective assessment will be repeated four times for the secondary objective: 2 test conditions (StereoZoom and SpeechSensor) against 2 target directions (better ear side, back). Following data are provided from assessment: rating on a 100-point scale per condition and per dimension.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start3 Nov 2022
- Primary completion31 Jan 2023
- Study completion17 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, BilateralStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonova AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthias Latzel, Study director, Sonova AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656313
- Sponsor's protocol ID
- SRF-2391
- Status last verified
- Dec 2022
- First submitted
- 16 Nov 2022
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feature Supporting Multitasking of Visual and Acoustical Objects
- ClinicalTrials.gov ID
- NCT05656313
- Acronym / sponsor ID
- SRF-2391
- Conditions
- Hearing Loss, Bilateral, Hearing Loss, Unilateral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 17 Feb 2023 (actual)
- First posted
- 19 Dec 2022 (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.
The investigation proposes to compare a narrow reference beamformer to a novel beamformer approach, when the talker is not in front of the hearing aid user and in the presence of background noise. The beamformer effect will be determined in terms of speech intelligibility, listening effort and ability to multitask when the talkers are located on the side or in the back.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Narrow reference beamformer | Experimental | Device: Measures of speech intelligibility in a noisy situation with speech from the side and from behind (measured with CC-OLSA Test), Device: Measures of the subjective speech recognition threshold in a noisy situation with speech from the side and from behind (measured with HEISS test), Device: Ability to multitask in the auditory and visual domains in noisy situation with speech from the side and from behind (Multitask test), Device: Measure of subjective speech intelligibility and listening effort in noisy situation with speech from the side and from behind (subjective assessment; 100-point scale) |
| Novel beamformer approach | Active comparator | Device: Measures of speech intelligibility in a noisy situation with speech from the side and from behind (measured with CC-OLSA Test), Device: Measures of the subjective speech recognition threshold in a noisy situation with speech from the side and from behind (measured with HEISS test), Device: Ability to multitask in the auditory and visual domains in noisy situation with speech from the side and from behind (Multitask test), Device: Measure of subjective speech intelligibility and listening effort in noisy situation with speech from the side and from behind (subjective assessment; 100-point scale) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Experienced (minimum use duration 6 months)
- Adult (minimum age: 18 years) hearing aid users,
- Written and spoken German,
- Ability to understand instruction,
- Ability to perform tests successfully
Key exclusion criteria (4 listed)
- Clinical contraindications deformity of the ear (closed ear canal or absence of pinna),
- Known hypersensitivity or allergy,
- Not willing to wear the hearing aid,
- Fluctuating hearing that could influence the results.
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 |
|---|---|---|
| Measures of speech intelligibility in a noisy situation with speech from the side and from behind (measured with CC-OLSA Test)The Concurrent OLSA test (CC-OLSA) is a speech recognition test with three turn-taking talkers presenting sentences of the Oldenburg sentences test at fixed signal-to-noise ratios. CC-OLSA is the only one-talker-at-a-time speech test that is sensitive at the desired SNR and uses sentences with an intelligibility function with slopes of 10-17 %/dB. | Device | Narrow reference beamformer, Novel beamformer approach |
| Measures of the subjective speech recognition threshold in a noisy situation with speech from the side and from behind (measured with HEISS test)The measure of the subjective speech recognition threshold is an alternative procedure to evaluate the subjective speech intelligibility in different listening conditions. The subjective speech recognition threshold is defined as the speech presentation level of running speech needed to just follow conversation. Subjects have to adjust the presentation level of speech so that they are just able to understand the speech, using a slider on a touch screen. This adjustment is repeated 10 times. Each adjustment results in a value for the subjective speech recognition threshold in dB SNR. The outcome measure is the mean value of the 10 repetitions. The HEISS-Test will be repeated four times for the secondary objective: test for 2 test conditions (Reference, novel approach) against 2 target directions (better ear side, back). | Device | Narrow reference beamformer, Novel beamformer approach |
| Ability to multitask in the auditory and visual domains in noisy situation with speech from the side and from behind (Multitask test)This test uses a dual-task-paradigm assessing vigilance for auditory and visual triggers concurrently. The primary task is to listen to a novel (Harry Potter) and respond on two trigger words by pressing the appropriate button (one in each hand). The secondary task is to observe a monitor showing a sequence of random signs and respond on a target sign by pressing both buttons. The test includes at least 100 triggers (50 auditory, 50 visual) and takes 10 minutes per condition (side vs. back; novel approach vs. reference; 40 minutes in total). The multitask test will be repeated four times for the secondary objective: 2 conditions (Refrence, novel approach) against 2 target directions (better ear side, back). Following data are provided from each multitask Test measure: (1) subjective rating of the perceived ability to perform the visual and the auditory test simultaneously. (2) reaction times to auditory and visual tasks, and (3) accuracy. | Device | Narrow reference beamformer, Novel beamformer approach |
| Measure of subjective speech intelligibility and listening effort in noisy situation with speech from the side and from behind (subjective assessment; 100-point scale)In addition to the tests mentioned above a subjective assessment will be used to determine the subjective perception as this measure is often a good indication for clinical relevance. For this purpose, the same speech material as used in the HEISS-test is presented by a loudspeaker in the same noisy environment as in the other three tests. The subjects rate his/her perception of the presented speech using a questionnaire on the dimensions "listen effort and speech intelligibility". The subject will rate his perception on the 100 point scale with pencils with different colors to get either absolute and relative ratings. The subjective assessment will be repeated four times for the secondary objective: 2 test conditions (Rference and novel approach) against 2 target directions (better ear side, back). Following data are provided from assessment: rating on a 100-point scale per condition and per dimension. | Device | Narrow reference beamformer, Novel beamformer approach |
Primary outcome
Difference in speech intelligibility between the reference beamformer and the novel beamformer approach (percentage of correct responses in word recognition) in a noisy situation with speech from the side and from behind.
Time frame: 4 weeks
Two directional conditions (better ear side, back) and two beamformer conditions (Novel approach: SpeechSensor, Reference: StereoZoom) are tested (test and retest, eight measurements in total).
3 secondary outcomes
Difference in speech recognition threshold between the reference beamformer and the novel (mean value of 10 repetitions).
Time frame: 4 weeks
Difference in multitasking ability between the reference beamformer and the novel (1. Respond on two trigger words / 2. Respond on a target sign).
Time frame: 4 weeks
Difference in subjective speech intelligibility between the reference beamformer and the novel (subjects rate his/her perception of the presented speech).
Time frame: 4 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 27 Mar 2023.
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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.
Matthias Latzel study director
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 Measures of speech intelligibility in a noisy situation with speech from the side and from behind (measured with CC-OLSA Test), Measures of the subjective speech recognition threshold in a noisy situation with speech from the side and from behind (measured with HEISS test) and Ability to multitask in the auditory and visual domains in noisy situation with speech from the side and from behind (Multitask test) in people with Hearing Loss, Bilateral and Hearing Loss, Unilateral, run by Sonova AG at 1 site in Germany.
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 10 inclusion and 4 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 27 Mar 2023. 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 Germany. 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?
Difference in speech intelligibility between the reference beamformer and the novel beamformer approach (percentage of correct responses in word recognition) in a noisy situation with speech from the side and from behind. (time frame: 4 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 27 Mar 2023.