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Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2020_09

Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2020_09

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04578457
Enrollment
19
Registered
2020-10-08
Start date
2020-10-23
Completion date
2021-04-22
Last updated
2021-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss

Brief 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. 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.

Interventions

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.

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.

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).

DEVICEHearing 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).

Sponsors

Sonova AG
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Differences in Event-related-skin-conductance6 weeksSkin 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)6 weeksPupil 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.

Secondary

MeasureTime frameDescription
Oldenburg Sentence Test6 weeksWords recalled correctly: words repeated back by participants are logged and the percentage of words recalled correctly calculated.
Sound Quality Ratings6 weeksThe 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.
Spectro-temporal-modulation Detection Thresholds (STM)6 weeksStimuli 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.

Other

MeasureTime frameDescription
Skin Temperature Data6 weeksSkin temperature will be recorded from participants during the auditory task using a small thermometer attached to the outside of the little finger (non-dominant hand). This data will only be used to control for changes in temperature which may influence skin conductance measurements.
Non-verbal Trail Making Test A & B2 weeksThe Trail Making Test (TMT) is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible according to a given order. In version A the order is given by increasing digit number (i.e. 1-25) while in version B the order is given by alternating digits and letters (i.e. 1-A-2-B-3-C…). The data, serving as an outcome measure, are time-to-complete the set in seconds.
Acoustic Reflex Thresholds3 weeksTympanometry will be used to assess the mobility of the eardrum, prior to recording Acoustic Reflex Thresholds (ARTs). Compliance \[ml\], Middle Ear Pressure \[daPa\] and ear canal volume \[ml\] will be recorded and checked that they fall within normal limits. Where this is the case, ARTs will be measured using 0.5, 1 & 2 kHz stimulus tones ipsi- and contralaterally for each ear. The resulting outcome measure will be the threshold \[dB\] required at each frequency and ear arrangement for a stapedial reflex to be present.
Digit-Span Test Forward (FW) & Backward (BW)2 weeksThe digit-span task is used to measure working memory's number storage capacity. Participants will see a sequence of numerical digits and are tasked to recall the sequence correctly, with increasingly longer sequences being tested in each trial. The participant's span is the longest number of sequential digits that can accurately be remembered, which means that the participant recalls two sequences out of a maximum of three sequences correct. Digit-span tasks can be given forwards or backwards, meaning that once the sequence is presented, the participant is asked to either recall the sentence in normal or reverse order.
Go/No-go Task6 weeksThe Go/No-go task measures inhibitory control. Participants are asked to respond to a Go stimulus as fast as possible but not respond to a No-go stimulus. Go stimuli are presented at a rate much higher than the No-go stimuli to elicit prepotent motor activity. The outcome measure of this task is the number of commission errors (i.e. responding to a No-go stimuli) a participant commits as a measure of their ability to stop prepotent motor activity.
Blood Volume Pulse6 weeksBlood volume pulse will be recorded from participants during the performance of the auditory task (non-invasively with a photoplethysmographic (PPG) sensor). Analyses will be carried out on the data recorded during a time window following each auditory stimulus (relative to baseline activity). It is planned to analyze event-related changes in pulse rate and amplitude (beats per minute).
Respiration Data6 weeksRespiration rates will be recorded from participants during the auditory task using a belt placed under the ribcage. This data will only be used to control for changes in breathing patterns which may influence skin conductance measurements.

Countries

Switzerland

Participant flow

Participants by arm

ArmCount
Study Cohort
This study was a crossover design, therefore there was only a single study group. This group undertook measures under each of the study conditions.
19
Total19

Withdrawals & dropouts

PeriodReasonFG000
Hearing Aid With NR (1)Withdrawal by Subject2
Hearing Aid With NR (2)Withdrawal by Subject2
Hearing Aid With NR (4)Withdrawal by Subject2
Hearing Aid Without NR Enabled (0)Withdrawal by Subject2

Baseline characteristics

CharacteristicStudy Cohort
Age, Continuous74.95 years
STANDARD_DEVIATION 7.42
Race and Ethnicity Not Collected— Participants
Region of Enrollment
Switzerland
19 Participants
Sex: Female, Male
Female
4 Participants
Sex: Female, Male
Male
15 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 19
other
Total, other adverse events
1 / 19
serious
Total, serious adverse events
0 / 19

Outcome results

Primary

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.

Time frame: 6 weeks

Population: The data from some participants had to be excluded from the analysis. Due to the noisy nature of physiological data, in some cases we were unable to collect enough valid, artefact-free data to analyse. Where this was the case, we discounted the participant from analyses.

ArmMeasureValue (MEAN)
Hearing Aid Without NR(0) EnabledDifferences in Event-related-pupil-dilation (ERPDs)217.713 pixels
Hearing Aid With NR (1)Differences in Event-related-pupil-dilation (ERPDs)217.301 pixels
Hearing Aid With NR(2)Differences in Event-related-pupil-dilation (ERPDs)158.732 pixels
Hearing Aid With NR(3)Differences in Event-related-pupil-dilation (ERPDs)186.526 pixels
Primary

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).

Time frame: 6 weeks

Population: The data from some participants had to be excluded from the analysis. Due to the noisy nature of physiological data, in some cases we were unable to collect enough valid, artefact-free data to analyse. Where this was the case, we discounted the participant from analyses. As we only contrasted NR(0) vs NR(1) and NR(2) vs NR(3) (and collected respective data at different study appointments), there is a slight discrepancy in the number of participants analysed for these study arms.

ArmMeasureValue (MEAN)
Hearing Aid Without NR(0) EnabledDifferences in Event-related-skin-conductance0.221 micro Siemens
Hearing Aid With NR (1)Differences in Event-related-skin-conductance0.189 micro Siemens
Hearing Aid With NR(2)Differences in Event-related-skin-conductance0.147 micro Siemens
Hearing Aid With NR(3)Differences in Event-related-skin-conductance0.126 micro Siemens
Secondary

Oldenburg Sentence Test

Words recalled correctly: words repeated back by participants are logged and the percentage of words recalled correctly calculated.

Time frame: 6 weeks

Population: By the time this outcome measure was performed, 1 of the original participants had withdrawn from the study.~Therefore, data for 18 participants was analysed.

ArmMeasureValue (MEAN)Dispersion
Hearing Aid Without NR(0) EnabledOldenburg Sentence Test92.778 Percentage of correct wordsStandard Deviation 3.296
Hearing Aid With NR (1)Oldenburg Sentence Test88.611 Percentage of correct wordsStandard Deviation 6.709
Hearing Aid With NR(2)Oldenburg Sentence Test96.157 Percentage of correct wordsStandard Deviation 2.271
Hearing Aid With NR(3)Oldenburg Sentence Test94.398 Percentage of correct wordsStandard Deviation 4.607
Secondary

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.

Time frame: 6 weeks

Population: By the time this outcome measure was performed, 2 of the original participants had withdrawn from the study.~Therefore, data for 17 participants was analysed.

ArmMeasureValue (MEAN)Dispersion
Hearing Aid Without NR(0) EnabledSound Quality Ratings3.275 score on a scaleStandard Error 0.263
Hearing Aid With NR (1)Sound Quality Ratings3.230 score on a scaleStandard Error 0.107
Hearing Aid With NR(2)Sound Quality Ratings3.054 score on a scaleStandard Error 0.208
Hearing Aid With NR(3)Sound Quality Ratings3.157 score on a scaleStandard Error 0.136
Secondary

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.

Time frame: 6 weeks

Population: By the time this outcome measure was performed, 2 of the original participants had withdrawn from the study.~Therefore, 17 participants had measurements for this outcome measure made. For 5 participants it was not possible to measure an STM threshold reliably at all test occasions.~Where this was the case, these participants were excluded from analyses.

ArmMeasureValue (MEAN)Dispersion
Hearing Aid Without NR(0) EnabledSpectro-temporal-modulation Detection Thresholds (STM)-8.181 decibelStandard Error 0.617
Other Pre-specified

Acoustic Reflex Thresholds

Tympanometry will be used to assess the mobility of the eardrum, prior to recording Acoustic Reflex Thresholds (ARTs). Compliance \[ml\], Middle Ear Pressure \[daPa\] and ear canal volume \[ml\] will be recorded and checked that they fall within normal limits. Where this is the case, ARTs will be measured using 0.5, 1 & 2 kHz stimulus tones ipsi- and contralaterally for each ear. The resulting outcome measure will be the threshold \[dB\] required at each frequency and ear arrangement for a stapedial reflex to be present.

Time frame: 3 weeks

Other Pre-specified

Blood Volume Pulse

Blood volume pulse will be recorded from participants during the performance of the auditory task (non-invasively with a photoplethysmographic (PPG) sensor). Analyses will be carried out on the data recorded during a time window following each auditory stimulus (relative to baseline activity). It is planned to analyze event-related changes in pulse rate and amplitude (beats per minute).

Time frame: 6 weeks

Other Pre-specified

Digit-Span Test Forward (FW) & Backward (BW)

The digit-span task is used to measure working memory's number storage capacity. Participants will see a sequence of numerical digits and are tasked to recall the sequence correctly, with increasingly longer sequences being tested in each trial. The participant's span is the longest number of sequential digits that can accurately be remembered, which means that the participant recalls two sequences out of a maximum of three sequences correct. Digit-span tasks can be given forwards or backwards, meaning that once the sequence is presented, the participant is asked to either recall the sentence in normal or reverse order.

Time frame: 2 weeks

Other Pre-specified

Go/No-go Task

The Go/No-go task measures inhibitory control. Participants are asked to respond to a Go stimulus as fast as possible but not respond to a No-go stimulus. Go stimuli are presented at a rate much higher than the No-go stimuli to elicit prepotent motor activity. The outcome measure of this task is the number of commission errors (i.e. responding to a No-go stimuli) a participant commits as a measure of their ability to stop prepotent motor activity.

Time frame: 6 weeks

Other Pre-specified

Non-verbal Trail Making Test A & B

The Trail Making Test (TMT) is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible according to a given order. In version A the order is given by increasing digit number (i.e. 1-25) while in version B the order is given by alternating digits and letters (i.e. 1-A-2-B-3-C…). The data, serving as an outcome measure, are time-to-complete the set in seconds.

Time frame: 2 weeks

Other Pre-specified

Respiration Data

Respiration rates will be recorded from participants during the auditory task using a belt placed under the ribcage. This data will only be used to control for changes in breathing patterns which may influence skin conductance measurements.

Time frame: 6 weeks

Other Pre-specified

Skin Temperature Data

Skin temperature will be recorded from participants during the auditory task using a small thermometer attached to the outside of the little finger (non-dominant hand). This data will only be used to control for changes in temperature which may influence skin conductance measurements.

Time frame: 6 weeks

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026