Physiological, Behavioural and Subjective Measures of Listening Effort

Hearing Loss Clinical Trial

Official title:

Effect of Noise Reduction Algorithms on Physiological, Behavioural and Subjective Measures of Listening Effort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03761927
• Other study ID #: Sonova2018_36
• Status: Completed
• Phase: N/A
• Start date: October 8, 2018
• Est. completion date: April 30, 2019

Study information

• Verified date: July 2019
• Source: Sonova AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: April 30, 2019
• Est. primary completion date: March 29, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• Hearing Aid without NR enabled
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.
• Hearing Aid with NR(1)
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.
• Hearing Aid with NR(2)
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).

Locations

Country	Name	City	State
Switzerland	Sonova AG	Stäfa

Sponsors (1)

Lead Sponsor	Collaborator
Sonova AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Hemoencephalography data	Hemoencephalography 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. Hemoencephalography will be analysed simply as the ratio of the blue and red light [%] during auditory task performance.	6 weeks
Secondary	Dual-task performance test 1	Performance on the secondary tracking task will be analysed in order to observe whether there is a dual-task cost associated with performing both tasks simultaneously. Typically the level of degradation on the secondary task is thought to reflect an increased listening effort (provided that the primary task performance remains stable). Accordingly, success on the primary task will also be monitored and used in analyses (speech intelligibility in [%] correct). For the Secondary task performance the reaction time [ms] will be analysed.	6 weeks
Secondary	Dual-task performance test 2	Performance on the secondary tracking task will be analysed in order to observe whether there is a dual-task cost associated with performing both tasks simultaneously. Typically the level of degradation on the secondary task is thought to reflect an increased listening effort (provided that the primary task performance remains stable). Accordingly, success on the primary task will also be monitored and used in analyses (comprehension questions [numbers] correct after listening to radio excerpts). For the Secondary task performance the reaction time [ms] will be analysed.	6 weeks
Secondary	Subjective Listening Effort rating	Subjective Listening Effort will also be assessed through self-reported individual listening effort on a 14 point scale from "only noise" to "no effort" after each auditory task.	6 weeks