Physiological, Behavioural and Subjective Measures of Listening Effort
Effect of Noise Reduction Algorithms on Physiological, Behavioural and Subjective Measures of Listening Effort
1 other identifier
interventional
17
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) 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).
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 2018
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
Study Start
First participant enrolled
October 8, 2018
CompletedFirst Submitted
Initial submission to the registry
November 30, 2018
CompletedFirst Posted
Study publicly available on registry
December 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 29, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2019
CompletedJuly 12, 2019
July 1, 2019
6 months
November 30, 2018
July 11, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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 \[micro-Siemens\].
6 weeks
Secondary Outcomes (4)
Hemoencephalography data
6 weeks
Dual-task performance test 1
6 weeks
Dual-task performance test 2
6 weeks
Subjective Listening Effort rating
6 weeks
Study Arms (3)
Hearing Aid without NR enabled.
ACTIVE COMPARATORHearing Aid without Noise Reduction (NR) 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.
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).
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)
Study Officials
- PRINCIPAL INVESTIGATOR
Juliane Raether
Sonova AG
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
November 30, 2018
First Posted
December 3, 2018
Study Start
October 8, 2018
Primary Completion
March 29, 2019
Study Completion
April 30, 2019
Last Updated
July 12, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share