NCT03704142

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 12, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

May 17, 2022

Completed
Last Updated

May 17, 2022

Status Verified

February 1, 2022

Enrollment Period

1.1 years

First QC Date

September 6, 2018

Results QC Date

October 12, 2021

Last Update Submit

February 28, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Difference in Self-rated Listening Effort

    One 2-hour session

Study Arms (4)

Tweak Focus

EXPERIMENTAL

Speech understanding and listening effort will be assessed using the Tweak Focus personal sound amplifiers.

Device: Tweak Focus

IQ Earbuds

EXPERIMENTAL

Speech understanding and listening effort will be assessed using the IQEarbuds personal sound amplifiers.

Device: IQ Earbuds

Sound World Solutions CS50+

EXPERIMENTAL

Speech understanding and listening effort will be assessed using the Sound World Solutions CS50+ personal sound amplifiers.

Device: Sound World Solutions CS50+

Bose Hearphones

EXPERIMENTAL

Speech understanding and listening effort will be assessed using the Sound World Solutions CS50+ personal sound amplifiers.

Device: Bose Hearphones

Interventions

Participants will be tested using the Sound World Solutions CS 50+ hearing devices.

Sound World Solutions CS50+

Participants will be tested using the Tweak Focus hearing devices.

Tweak Focus

Participants will be tested using the IQ Earbuds hearing devices.

IQ Earbuds

Participants will be tested using the Bose Hearphones hearing devices.

Bose Hearphones

Eligibility Criteria

Age45 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • mild high-frequency hearing loss (pure-tone thresholds of 25 decibels hearing loss - 45 decibels hearing loss between 2000 Hz and 6000 Hz)

You may not qualify if:

  • history of prior hearing aid use
  • history of neurologic or otologic disorders
  • score of \< 26 on Montreal Cognitive Assessment (cognitive screening tool)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Massachusetts Amherst

Amherst, Massachusetts, 01003, United States

Location

Results Point of Contact

Title
Dr. Karen Helfer
Organization
University of Massachusetts Amherst Dept. of Communication Disorders

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Each participant will be tested with one of the models of devices.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 6, 2018

First Posted

October 12, 2018

Study Start

March 1, 2019

Primary Completion

March 30, 2020

Study Completion

March 30, 2020

Last Updated

May 17, 2022

Results First Posted

May 17, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations