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Completed

NCT Number: NCT03992963

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

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.

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Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sonova AG

Stäfa, 8712, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hearing Aid without frequency lowering enabled

Device

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

Device

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 outcomes

  1. Changes in event-related-pupil-dilations (ERPDs) data

    Time frame: 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 outcomes

  1. self-perceived speech intelligibility rating

    Time frame: 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.

  2. behavioral emotion recognition categorical rating

    Time frame: 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.

  3. behavioral emotion recognition continuous rating

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sonova AG

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 20, 2019
Registry last updated
Oct 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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