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Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2019_04

Primary Purpose

Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Hearing Aid without frequency lowering enabled
Hearing Aid with frequency lowering enabled
Sponsored by
Sonova AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Sonova AG

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Hearing Aid without frequency lowering enabled

Hearing Aid with frequency lowering enabled

Arm Description

Outcomes

Primary Outcome Measures

Changes in event-related-pupil-dilations (ERPDs) data
Pupil dilations 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) and also 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 analyse event-related-pupil-dilations (ERPDs).

Secondary Outcome Measures

self-perceived speech intelligibility rating
Subjective speech intelligibility will be assessed through self-perceived speech intelligibility on a continuous scale from 0 (nothing) to 100 (everything) during a training phase only.
behavioral emotion recognition categorical rating
Behavioral ratings will be assessed in the final stage of the study during the active task. Participants will categorize stimuli into emotion categories (happy, sad, etc.) in a forced-choice task after each auditory stimulus is played.
behavioral emotion recognition continuous rating
Behavioral ratings will be assessed in the final stage of the study during the active task. Participants rate the valence and arousal of the stimulus on a continuous scale from 1 (very low) to 9 (very high) after each auditory stimulus is played.

Full Information

First Posted
June 19, 2019
Last Updated
October 10, 2019
Sponsor
Sonova AG
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1. Study Identification

Unique Protocol Identification Number
NCT03992963
Brief Title
Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2019_04
Official Title
Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
April 8, 2019 (Actual)
Primary Completion Date
June 28, 2019 (Actual)
Study Completion Date
July 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sonova AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Participants will take part in both a passive and active emotion recognition task: (1) passively listening to semantically-neutral sentences with emotional prosody, and (2) actively listening and subsequently categorizing emotional sentences and sounds. Participants are seated and instructed to stare at a fixation cross while the stimulus is played. During this study, non-invasive physiological measurements of pupil dilation will be recorded from the participants. Using this paradigm we will be assessing the effect of frequency lowering on emotion recognition. The study takes the form of a partly three factorial design (passive task x frequency lowering x acclimatization). Participants also perform a two factor design (active task x frequency lowering). Each participant performs two passive tests (20 minutes long each) with frequency lowering on and off, and a four week acclimatization period in-between. Participants perform one active listening task after the acclimatization period with frequency lowering on and off.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hearing Aid without frequency lowering enabled
Arm Type
Active Comparator
Arm Title
Hearing Aid with frequency lowering enabled
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Hearing Aid without frequency lowering enabled
Intervention Description
Each participant will be fitted with frequency lowering disabled. Disabled means standard hearing loss compensation without lowering higher frequencies in lower frequency areas. The input frequency is mapped to the same frequency in output.
Intervention Type
Device
Intervention Name(s)
Hearing Aid with frequency lowering enabled
Intervention Description
Each participant will be fitted with frequency lowering enabled. The principle of the frequency lowering algorithm is to lower high frequencies to a lower frequency region with the aim of ensuring high frequency audibility to improve auditory emotion recognition.
Primary Outcome Measure Information:
Title
Changes in event-related-pupil-dilations (ERPDs) data
Description
Pupil dilations 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) and also 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 analyse event-related-pupil-dilations (ERPDs).
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
self-perceived speech intelligibility rating
Description
Subjective speech intelligibility will be assessed through self-perceived speech intelligibility on a continuous scale from 0 (nothing) to 100 (everything) during a training phase only.
Time Frame
6 weeks
Title
behavioral emotion recognition categorical rating
Description
Behavioral ratings will be assessed in the final stage of the study during the active task. Participants will categorize stimuli into emotion categories (happy, sad, etc.) in a forced-choice task after each auditory stimulus is played.
Time Frame
6 weeks
Title
behavioral emotion recognition continuous rating
Description
Behavioral ratings will be assessed in the final stage of the study during the active task. Participants rate the valence and arousal of the stimulus on a continuous scale from 1 (very low) to 9 (very high) after each auditory stimulus is played.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juliane Raether
Organizational Affiliation
Sonova AG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sonova AG
City
Stäfa
ZIP/Postal Code
8712
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2019_04

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