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

Not Applicable

Completed

• Conditions: Hearing Loss

• Registration Number: NCT03992963
• Lead Sponsor: Sonova AG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-08
• Study First Submitted: 2019-06-19
• Study First Submitted QC: 2019-06-19
• Study First Posted: 2019-06-20
• Primary Completion: 2019-06-28
• Study Completion: 2019-07-26
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-10
• Last Update Posted: 2019-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Primary Outcome Measures

Name	Time	Method
Changes in event-related-pupil-dilations (ERPDs) data	6 weeks	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

Name	Time	Method
self-perceived speech intelligibility rating	6 weeks	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	6 weeks	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	6 weeks	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.

Trial Locations

Locations (1)

Sonova AG; 🇨🇭 Stäfa, Switzerland