Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2019_04
1 other identifier
interventional
8
1 country
1
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.
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 Apr 2019
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
April 8, 2019
CompletedFirst Submitted
Initial submission to the registry
June 19, 2019
CompletedFirst Posted
Study publicly available on registry
June 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 26, 2019
CompletedOctober 11, 2019
October 1, 2019
3 months
June 19, 2019
October 10, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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).
6 weeks
Secondary Outcomes (3)
self-perceived speech intelligibility rating
6 weeks
behavioral emotion recognition categorical rating
6 weeks
behavioral emotion recognition continuous rating
6 weeks
Study Arms (2)
Hearing Aid without frequency lowering enabled
ACTIVE COMPARATORHearing Aid with frequency lowering enabled
EXPERIMENTALInterventions
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.
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.
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
June 19, 2019
First Posted
June 20, 2019
Study Start
April 8, 2019
Primary Completion
June 28, 2019
Study Completion
July 26, 2019
Last Updated
October 11, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share