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

Primary Purpose

Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Hearing Aid without NR enabled
Hearing Aid with NR(1)
Hearing Aid with NR(2)
Hearing Aid with NR(3)
Sponsored by
Sonova AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sonova AG

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Hearing Aid without NR(0) enabled

Hearing Aid with NR (1)

Hearing Aid with NR(2)

Hearing Aid with NR(3)

Arm Description

Hearing Aid without Noise Reduction (NR 0) enabled serves as reference condition.

Hearing Aid with Noise Reduction I (NR) enabled.

Hearing Aid with Noise Reduction II (NR) enabled.

Hearing Aid with Noise Reduction III (NR) enabled.

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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

Full Information

First Posted
October 1, 2020
Last Updated
September 14, 2021
Sponsor
Sonova AG
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1. Study Identification

Unique Protocol Identification Number
NCT04578457
Brief Title
Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2020_09
Official Title
Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2020_09
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 23, 2020 (Actual)
Primary Completion Date
March 2, 2021 (Actual)
Study Completion Date
April 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sonova AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hearing Aid without NR(0) enabled
Arm Type
Active Comparator
Arm Description
Hearing Aid without Noise Reduction (NR 0) enabled serves as reference condition.
Arm Title
Hearing Aid with NR (1)
Arm Type
Experimental
Arm Description
Hearing Aid with Noise Reduction I (NR) enabled.
Arm Title
Hearing Aid with NR(2)
Arm Type
Experimental
Arm Description
Hearing Aid with Noise Reduction II (NR) enabled.
Arm Title
Hearing Aid with NR(3)
Arm Type
Experimental
Arm Description
Hearing Aid with Noise Reduction III (NR) enabled.
Intervention Type
Device
Intervention Name(s)
Hearing Aid without NR enabled
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Hearing Aid with NR(1)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Hearing Aid with NR(2)
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Hearing Aid with NR(3)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Differences in Event-related-skin-conductance
Description
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
Title
Differences in Event-related-pupil-dilation (ERPDs)
Description
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
Secondary Outcome Measure Information:
Title
Oldenburg Sentence Test
Description
Words recalled correctly: words repeated back by participants are logged and the percentage of words recalled correctly calculated.
Time Frame
6 weeks
Title
Sound Quality Ratings
Description
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
Title
Spectro-temporal-modulation Detection Thresholds (STM)
Description
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
Other Pre-specified Outcome Measures:
Title
Non-verbal Trail Making Test A & B
Description
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
Title
Digit-Span Test Forward (FW) & Backward (BW)
Description
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
Title
Go/No-go Task
Description
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
Title
Blood Volume Pulse
Description
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
Title
Respiration Data
Description
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
Title
Skin Temperature Data
Description
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
Title
Acoustic Reflex Thresholds
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Sonova AG
City
Stäfa
ZIP/Postal Code
8712
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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

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