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

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03992963
• Other study ID #: Sonova2019_04
• Status: Completed
• Phase: N/A
• Start date: April 8, 2019
• Est. completion date: July 26, 2019

Study information

• Verified date: October 2019
• Source: Sonova AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: July 26, 2019
• Est. primary completion date: June 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• Hearing Aid without frequency lowering enabled
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.
• Hearing Aid with frequency lowering enabled
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.

Locations

Country	Name	City	State
Switzerland	Sonova AG	Stäfa

Sponsors (1)

Lead Sponsor	Collaborator
Sonova AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	6 weeks
Secondary	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.	6 weeks
Secondary	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.	6 weeks