Hearing Study: Sensitivity to Features of Speech Sounds

• Sponsor: University of Rochester (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03666676
• Collaborator: National Institute on Deafness and Other Communication Disorders (NIDCD) (NIH)
• Enrollment: 200
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 41.7
• Patients Per Site Per Month: 4.8

Study Details

Study Description

Brief Summary

The purpose of this study is to better understand the sensitivity of listeners to the fast changes in frequency or amplitude of sounds that occur in speech. The investigators are studying ways to manipulate these aspects of sounds in an effort to make speech sounds more clear.

Condition or Disease	Intervention/Treatment	Phase
Hearing Loss, Sensorineural	Other: Signal processing to improve intelligibility	N/A

Detailed Description

The investigators will test listeners with normal hearing or with mild or moderate hearing loss. Tests will first focus on sensitivity to changes in fast changes in amplitude (loudness) or frequency (pitch) in sounds. Then the investigators will test the intelligibility of synthetic vowels and syllables in which these "chirps" are manipulated. Finally, the investigators will test intelligibility of words in noise while manipulating sounds in an effort to improve clarity.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Auditory Processing of Complex Sounds - Sensitivity to Chirps
• Actual Study Start Date: Jun 9, 2020
• Anticipated Primary Completion Date: Nov 30, 2023
• Anticipated Study Completion Date: Nov 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Normal Hearing Signal processing to improve intelligibility	Other: Signal processing to improve intelligibility; Signal processing will be used to manipulate frequency and amplitude fluctuations in complex sounds.
Active Comparator: Mild hearing loss Signal processing to improve intelligibility	Other: Signal processing to improve intelligibility; Signal processing will be used to manipulate frequency and amplitude fluctuations in complex sounds.
Active Comparator: Moderate hearing loss Signal processing to improve intelligibility	Other: Signal processing to improve intelligibility; Signal processing will be used to manipulate frequency and amplitude fluctuations in complex sounds.

Outcome Measures

Primary Outcome Measures

1. Discrimination thresholds for formant-freq difference limens [5 years]

   Measures of discrimination thresholds (in units of "% of Formant Frequency" at the discrimination threshold) for different formant bandwidths and for different alignments of formants and harmonics.

Secondary Outcome Measures

1. % of correct synthetic vowels [5 years]

   % correct answers

2. % of correct synthetic syllables [5 years]

   % correct answers

3. % of correct words [5 years]

   % correct answers using SPiN test

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Normal hearing, mild or moderate symmetric sensorineural hearing loss.

Exclusion Criteria:

• Asymmetric hearing thresholds (more than 15 decibels (dB) threshold difference between the two ears at any frequency up to 4 kHz).

• Severe hearing loss (greater than 60 dB hearing thresholds at any frequency up to 4 kHz).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Rochester	Rochester	New York	United States	14642

Sponsors and Collaborators

• University of Rochester
• National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Laurel Carney, Professor, University of Rochester
• ClinicalTrials.gov Identifier: NCT03666676
• Other Study ID Numbers: 73346; R01DC001641
• First Posted: Sep 12, 2018
• Last Update Posted: Nov 17, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hearing Loss; Hearing Loss, Sensorineural

Study Results

No Results Posted as of Nov 17, 2021