Hearing Aid Processing and Working Memory in Realistic Sp... | NCT04521166

ID	Type	Description	Link
K01DC018324	U.S. NIH Grant/Contract		View source

Hearing Aid Processing and Working Memory in Realistic Sp... | NCT04521166 | Trialant

Sponsor/Collaborators Module

Name	Class
National Institute on Deafness and Other Communication Disorders (NIDCD)	NIH

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Setting 1	Experimental	Hearing aid features presented in this arm include omnidirectional microphone settings and fast-acting compression	Device: Hearing aid
Setting 2	Experimental	Hearing aid features presented in this arm include omnidirectional microphone settings and slow-acting compression	Device: Hearing aid
Setting 3	Experimental	Hearing aid features presented in this arm include directional microphone settings and fast-acting compression	Device: Hearing aid
Setting 4	Experimental	Hearing aid features presented in this arm include directional microphone settings and slow-acting compression	Device: Hearing aid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hearing aid	Device	Settings in a wearable hearing aid will be adjusted within a clinically-relevant range for two features. The features include wide dynamic range compression and microphone directionality.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Speech Intelligibility (Percent Correct Scores)	Listeners will listen to and repeat recorded low-context sentences mixed with noise from different spatial locations. Speech intelligibility will be measured immediately following hearing aid fitting. Scoring is determined by percentage of words repeated correctly. Scores range from 0-100% (higher score indicates better performance). This task may take up to 1-2 visits (~ 2 hours each) for different combinations of hearing aid features. The device will only be worn in the laboratory for the duration of the experimental task and will be retrieved by the investigator at the end of each visit.	~20 mins for each intervention over the course of 1-2 days

Contacts/Locations Module

Name	Affiliation	Role
Varsha Rallapalli, AuD, PhD	Northwestern University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Northwestern University		Evanston	Illinois	60208	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39620655	Derived	Rallapalli V, Freyman R, Souza P. Relationship Between Working Memory, Compression, and Beamformers in Ideal Conditions. Ear Hear. 2025 Mar-Apr 01;46(2):523-536. doi: 10.1097/AUD.0000000000001605. Epub 2024 Nov 6.

Arm/Group Information

ID	Title	Description
FG000	Hearing Aid Setting: Single Arm	All participants listened to hearing aid features presented in this arm include omnidirectional microphone settings, directional microphone settings, slow-acting compression, and fast-acting compression Hearing aid: Settings in a wearable hearing aid will be adjusted within a clinically-relevant range for two features. The features include wide dynamic range compression and microphone directionality.

Periods

Title

Milestones

Reasons Not Completed

Sub-study 1

Type	Comment	Milestone Data
STARTED		FG00021 subjects
COMPLETED		FG00021 subjects
NOT COMPLETED		FG0000 subjects

Sub-study 2

Type	Comment	Milestone Data
STARTED		FG00023 subjectsParticipation in Sub-study 2 and Sub-study 3 was optional for the participants from Sub-study 1. Additionally, participants were allowed to participate in any of the Sub-studies independent from other Sub-studies. From Sub-study 1 to Sub-study 2, 7 participants continued, 14 dropped out, 16 were added.
COMPLETED		FG00023 subjects
NOT COMPLETED		FG000

Sub-study 3

Type	Comment	Milestone Data
STARTED		FG00017 subjectsParticipation in Sub-study 3 was optional for the participants from Sub-study 1 and Sub-study 2. Additionally, participants were allowed to participate in any of the Sub-studies independent from other Sub-studies. From Sub-study 2 to Sub-study 3, 9 participants continued, 14 dropped out, 8 were added. Among the participants added newly in Sub-study 3, there were 3 participants previously completed Sub-study 1 (but not Sub-study 2). Total of 5 participants completed all 3 Sub-studies.
COMPLETED		FG00017 subjects
NOT COMPLETED		FG000

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Hearing Aid Setting	Hearing aid features presented in this arm include omnidirectional microphone settings, directional microphone settings, fast-acting compression, and slow-acting compression Hearing aid: Settings in a wearable hearing aid will be adjusted within a clinically-relevant range for two features. The features include wide dynamic range compression and microphone directionality.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Speech Intelligibility (Percent Correct Scores)

Listeners will listen to and repeat recorded low-context sentences mixed with noise from different spatial locations. Speech intelligibility will be measured immediately following hearing aid fitting. Scoring is determined by percentage of words repeated correctly. Scores range from 0-100% (higher score indicates better performance). This task may take up to 1-2 visits (~ 2 hours each) for different combinations of hearing aid features. The device will only be worn in the laboratory for the duration of the experimental task and will be retrieved by the investigator at the end of each visit.

A total of 42 participants were tested for the study. The study design was a full factorial design where each participant completed the outcome measures with all 4 settings in sub-studies 1 & 2. In Sub-study 3, the outcome measures were completed with Settings 1 & 3 only. Due to an error in assigning settings, 1 participant each did not listen with settings 1 & 3 in sub-study 1; 1 participant did not listen with Setting 3 in sub-study 3.

Posted

Mean

95% Confidence Interval

percentage of words correct

~20 mins for each intervention over the course of 1-2 days

Data Points

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Hearing Aid Setting	Hearing aid features presented in this arm include omnidirectional microphone settings, directional microphone settings, fast-acting compression, and slow-acting compression. Hearing aid: Settings in a wearable hearing aid will be adjusted within a clinically-relevant range for two features. The features include wide dynamic range compression and microphone directionality.

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Varsha Rallapalli	Northwestern University	847-467-0897		varsha8904@gmail.com

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 25, 2024	Jun 26, 2024	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Jun 25, 2024	Jun 26, 2024	SAP_001.pdf

Condition Browse Module

ID	Term
D006319	Hearing Loss, Sensorineural

ID	Term
D034381	Hearing Loss
D006311	Hearing Disorders
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases

Intervention Browse Module

ID	Term
D006310	Hearing Aids

ID	Term
D000076251	Wearable Electronic Devices
D055615	Electrical Equipment and Supplies
D004864	Equipment and Supplies
D012682	Sensory Aids

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000
Asian	BG0000
Native Hawaiian or Other Pacific Islander	BG0000
Black or African American	BG0000
White	BG00042
More than one race	BG0000
Unknown or Not Reported	BG0000

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Estimate Comment	Non-Inferiority Type	Non-Inferiority Comment
OG000 OG001		Mixed Models Analysis	0.5291	The a priori threshold for statistical significance was 0.05. P-value was adjusted for multiple comparisons using the Bonferroni correction.	Slope	-0.00990	Standard Error of the Mean	0.01572	2-Sided	95	-0.04075	0.02095	Setting 2 was considered as the reference and the estimate reflects whether the slope for Setting 1 is significantly different from the slope for Setting 2	Other	A linear mixed model was used to assess whether there was a difference between Settings 1 and 2.
OG001 OG002		Mixed Models Analysis	<0.001	The a priori threshold for statistical significance was 0.05. P-value was adjusted for multiple comparisons using the Bonferroni correction.	Slope	0.1329	Standard Error of the Mean	0.01740	2-Sided	95	0.09880	0.1671	Setting 2 was considered as the reference and the estimate reflects whether the slope for Setting 3 is significantly different from the slope for Setting 2	Other	A linear mixed model was used to assess whether there was a difference between Setting 2 and Setting 3.
OG001 OG003		Mixed Models Analysis	<.0001	The a priori threshold for statistical significance was 0.05. P-value was adjusted for multiple comparisons using the Bonferroni correction.	Slope	0.2016	Standard Error of the Mean	0.01812	2-Sided	95	0.1660	0.2371	Setting 2 was considered as the reference and the estimate reflects whether the slope for Setting 4 is significantly different from the slope for Setting	Other	A linear mixed model was used to assess whether there was a difference between Setting 2 and Setting 4.
OG000	A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after controlling for age and degree of hearing loss (decibel hearing level)	Mixed Models Analysis	0.242	The a priori threshold for statistical significance was 0.05.	Slope	0.002			2-Sided					Other	A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after controlling for age and degree of hearing loss (decibel hearing level)
OG001	A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after controlling for age and degree of hearing loss (decibel hearing level)	Mixed Models Analysis	0.242	The a priori threshold for statistical significance was 0.05.	Slope	0.002			2-Sided					Other	A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after controlling for age and degree of hearing loss (decibel hearing level)
OG002	A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after accounting for age and degree of hearing loss (decibel hearing level).	Mixed Models Analysis	0.242	The a priori threshold for statistical significance was 0.05.	Slope	0.002			2-Sided					Other	A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after accounting for age and degree of hearing loss (decibel hearing level).
OG003	A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after accounting for age and degree of hearing loss (decibel hearing level).	Mixed Models Analysis	0.242	The a priori threshold for statistical significance was 0.05.	Slope	0.002			2-Sided					Other	A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after accounting for age and degree of hearing loss (decibel hearing level).