Physiological, Behavioural and Subjective Measures of Listening Effort

Not Applicable

Completed

• Conditions: Hearing Loss
• Interventions: Device: Hearing Aid with NR(1); Device: Hearing Aid without NR enabled; Device: Hearing Aid with NR(2)

• Registration Number: NCT03761927
• Lead Sponsor: Sonova AG

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-08
• Study First Submitted: 2018-11-30
• Study First Submitted QC: 2018-11-30
• Study First Posted: 2018-12-03
• Primary Completion: 2019-03-29
• Study Completion: 2019-04-30
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-11
• Last Update Posted: 2019-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hearing Aid with NR(1)	Hearing Aid with NR(1)	Hearing Aid with Noise Reduction I (NR) enabled.
Hearing Aid without NR enabled.	Hearing Aid without NR enabled	Hearing Aid without Noise Reduction (NR) enabled serves as reference condition.
Hearing Aid with NR(2)	Hearing Aid with NR(2)	Hearing Aid with Noise Reduction II (NR) enabled.

Primary Outcome Measures

Name	Time	Method
Heart rate variability data	6 weeks	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.
Skin conductance data	6 weeks	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 \[micro-Siemens\].

Secondary Outcome Measures

Name	Time	Method
Dual-task performance test 1	6 weeks	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.
Dual-task performance test 2	6 weeks	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.
Subjective Listening Effort rating	6 weeks	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.
Hemoencephalography data	6 weeks	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.

Trial Locations

Locations (1)

Sonova AG; 🇨🇭 Stäfa, Switzerland