Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2020_09
1 other identifier
interventional
19
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2020
CompletedFirst Posted
Study publicly available on registry
October 8, 2020
CompletedStudy Start
First participant enrolled
October 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 2, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 22, 2021
CompletedResults Posted
Study results publicly available
July 28, 2021
CompletedOctober 5, 2021
August 1, 2021
4 months
October 1, 2020
July 6, 2021
September 14, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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).
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.
6 weeks
Secondary Outcomes (3)
Oldenburg Sentence Test
6 weeks
Sound Quality Ratings
6 weeks
Spectro-temporal-modulation Detection Thresholds (STM)
6 weeks
Other Outcomes (7)
Non-verbal Trail Making Test A & B
2 weeks
Digit-Span Test Forward (FW) & Backward (BW)
2 weeks
Go/No-go Task
6 weeks
- +4 more other outcomes
Study Arms (4)
Hearing Aid without NR(0) enabled
ACTIVE COMPARATORHearing Aid without Noise Reduction (NR 0) enabled serves as reference condition.
Hearing Aid with NR (1)
EXPERIMENTALHearing Aid with Noise Reduction I (NR) enabled.
Hearing Aid with NR(2)
EXPERIMENTALHearing Aid with Noise Reduction II (NR) enabled.
Hearing Aid with NR(3)
EXPERIMENTALHearing Aid with Noise Reduction III (NR) enabled.
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).
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sonova AGlead
Study Sites (1)
Sonova AG
Stäfa, 8712, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Juliane Raether
- Organization
- Sonova AG
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2020
First Posted
October 8, 2020
Study Start
October 23, 2020
Primary Completion
March 2, 2021
Study Completion
April 22, 2021
Last Updated
October 5, 2021
Results First Posted
July 28, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share