Physiological, Behavioural and Subjective Measures of Listening Effort

NCT ID: NCT03761927

Last Updated: 2019-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-08

Study Completion Date

2019-04-30

Brief Summary

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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

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Conditions

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Hearing Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Hearing Aid without NR enabled.

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

Group Type ACTIVE_COMPARATOR

Hearing Aid without NR enabled

Intervention Type DEVICE

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)

Hearing Aid with Noise Reduction I (NR) enabled.

Group Type EXPERIMENTAL

Hearing Aid with NR(1)

Intervention Type DEVICE

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)

Hearing Aid with Noise Reduction II (NR) enabled.

Group Type EXPERIMENTAL

Hearing Aid with NR(2)

Intervention Type DEVICE

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).

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

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).

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sonova AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Juliane Raether

Role: PRINCIPAL_INVESTIGATOR

Sonova AG

Locations

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Sonova AG

Stäfa, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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Sonova2018_36

Identifier Type: -

Identifier Source: org_study_id

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