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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03704142
Other study ID # UMassAmherst
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2019
Est. completion date March 30, 2020

Study information

Verified date February 2022
Source University of Massachusetts, Amherst
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will measure the performance of three personal amplification devices when used by middle-aged adults. Speech understanding will be assessed with two different types of background noises at three different input levels.


Description:

Speech understanding will be measured both unaided and aided with three different models of Personal Amplification devices (PSAPs). Sentences will be played to the participant from a loudspeaker located in front. Different types of background sounds (noise and other sentences) will be played from loudspeakers located to the right and left of the participant. Participants will be instructed to repeat back the sentence coming from the front. They also will rate subjective effort at the end of each block of trials.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date March 30, 2020
Est. primary completion date March 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 45 Years to 64 Years
Eligibility Inclusion Criteria: - mild high-frequency hearing loss (pure-tone thresholds of 25 decibels hearing loss - 45 decibels hearing loss between 2000 Hz and 6000 Hz) Exclusion Criteria: - history of prior hearing aid use - history of neurologic or otologic disorders - score of < 26 on Montreal Cognitive Assessment (cognitive screening tool)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Sound World Solutions CS50+
Participants will be tested using the Sound World Solutions CS 50+ hearing devices.
Tweak Focus
Participants will be tested using the Tweak Focus hearing devices.
IQ Earbuds
Participants will be tested using the IQ Earbuds hearing devices.
Bose Hearphones
Participants will be tested using the Bose Hearphones hearing devices.

Locations

Country Name City State
United States University of Massachusetts Amherst Amherst Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
University of Massachusetts, Amherst

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of How Four Models of Personal Listening Devices Improve Word Understanding in Noise Improvement in performance on speech perception task using the Nuheara IQ Buds, Tweak Focus, Bose Hearphones, or the Sound World Solutions CS 50+ personal listening devices, measured by percentage of words accurately recalled in noise with device minus percentage recalled without device. Positive values indicate improvement in performance. One 2-hour lab session
Secondary Difference in Self-rated Listening Effort Effect of listening devices on subjective listening effort, measured by rating on ten-point scale (10 = greatest amount of effort) after task performed with device minus rating after task performed without device. Lower scores indicate less listening effort; negative values indicate reduction in effort with device. One 2-hour session
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