Fitting Strategy Study | NCT04972162

Name	Class
University of South Dakota	OTHER

Fitting Strategy Study | NCT04972162 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Web-App-fitted Hearing Aid, Then Standard-of-care fitted Hearing Aid	Experimental	Patients self-fitted the web-app-fitted hearing aids and wore them in a home-trial for 14 days. After a washout period of 5 days, they were fitted by a hearing care professional with the Standard-of-care fitted hearing aids and wore those in a home-trial for 14 days.	Device: Web App Strategy Fitting Device: Standard-of-care Fitting
Standard-of-care-fitted Hearing Aid, Then Web-App-fitted hearing Aid	Experimental	Patients were fitted by a hearing care professional with the Standard-of-care fitted hearing aids and wore them in a home-trial for 14 days. After a washout period of 5 days, they self-fitted the web-app-fitted hearing aids and wore those in a home-trial for 14 days.	Device: Web App Strategy Fitting Device: Standard-of-care Fitting

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Web App Strategy Fitting	Device	Web App Strategy fitting of hearing aids	Standard-of-care-fitted Hearing Aid, Then Web-App-fitted hearing Aid Web-App-fitted Hearing Aid, Then Standard-of-care fitted Hearing Aid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Abbreviated Profile of Hearing Aid Benefit (APHAB)	The APHAB consists of 24 questions across 4 subscales: Ease of Communication (EC), Background Noise (BN), Reverberation (RV), and Aversiveness (AV), assessing hearing difficulties in daily situations reported as percentage of problems (0-100%, 100% = highest number of problems). It evaluates hearing aid (HA) benefit by subtracting the reported % of problems with HA from without HA, yielding scores from 0 (no benefit) to 100 (maximum benefit) in each subscale. The study focuses on the communication subscales (EC, BN, RV) and calculates benefit score differences for each subscale after using A) Web-App-fitted and B) standard-of-care-fitted HAs. The difference-of-benefit scores are compared to non-inferiority margins from Cox&Alexander (Ear&Hearing 1995). Differences-in-benefit scores range from -100 to 100, with negative scores indicating greater benefit with Web-App-fitted HAs, 0 indicating identical benefit and higher scores indicating greater benefit with standard-of-care fitting.	14-17 Days hearing aid wearing time per fitting type

Contacts/Locations Module

Name	Affiliation	Role
Lindsey Jorgensen	University of South Dakota	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of South Dakota, USD Speech and Hearing Clinic		Vermillion	South Dakota	57069	United States

Arm/Group Information

ID	Title	Description
FG000	Web-App-fitted Hearing Aid, Then Standard-of-care Fitted Hearing Aid	Patients self-fitted the web-app-fitted hearing aids and wore them in a home-trial for 14 days. After a washout period of 5 days, they were fitted by a hearing care professional with the Standard-of-care fitted hearing aids and wore those in a home-trial for 14 days.
FG001	Standard-of-care Fitted Hearing Aid, Then Web-App-fitted Hearing Aid	Patients were fitted by a hearing care professional with the Standard-of-care fitted hearing aids and wore them in a home-trial for 14 days. After a washout period of 5 days, they self-fitted the web-app-fitted hearing aids and wore those in a home-trial for 14 days.

Periods

Title

Milestones

Reasons Not Completed

First Intervention (14 Days)

Type	Comment	Milestone Data
STARTED		FG00014 subjects FG00114 subjects
COMPLETED		FG00014 subjects FG00114 subjects
NOT COMPLETED		FG0000 subjects FG0010 subjects

Washout Period (5 Days)

Type	Comment	Milestone Data
STARTED		FG00014 subjects FG00114 subjects
COMPLETED		FG00013 subjects FG001

Second Intervention (14 Days)

Type	Comment	Milestone Data
STARTED		FG00013 subjects FG00113 subjects
COMPLETED		FG00013 subjects FG001

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Study Participants	Baseline measures are only given for the total group of study participants because of the cross-over design (all participants took part in both arms)

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

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	Abbreviated Profile of Hearing Aid Benefit (APHAB)	The APHAB consists of 24 questions across 4 subscales: Ease of Communication (EC), Background Noise (BN), Reverberation (RV), and Aversiveness (AV), assessing hearing difficulties in daily situations reported as percentage of problems (0-100%, 100% = highest number of problems). It evaluates hearing aid (HA) benefit by subtracting the reported % of problems with HA from without HA, yielding scores from 0 (no benefit) to 100 (maximum benefit) in each subscale. The study focuses on the communication subscales (EC, BN, RV) and calculates benefit score differences for each subscale after using A) Web-App-fitted and B) standard-of-care-fitted HAs. The difference-of-benefit scores are compared to non-inferiority margins from Cox&Alexander (Ear&Hearing 1995). Differences-in-benefit scores range from -100 to 100, with negative scores indicating greater benefit with Web-App-fitted HAs, 0 indicating identical benefit and higher scores indicating greater benefit with standard-of-care fitting.	All participants who completed the study visits were included in the efficacy analysis. The intention to treat (ITT) population includes 2 subjects who withdrew from study. It was concluded that their primary endpoint data was missing for cause and their APHAB benefit scores (change from baseline) was imputed as 0 for each subscale	Posted		Mean	Standard Deviation	score on a scale		14-17 Days hearing aid wearing time per fitting type

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	Web App Fitted Hearing Aids	Web App fitted hearing aids will be worn by subject for 14 days. Web App Strategy Fitting: Web App Strategy fitting of hearing aids

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Dr. Veronika Littmann	WSAUDAS	+4991313080		veronika.littmann@wsa.com

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Sep 8, 2021	Nov 11, 2024	Prot_SAP_000.pdf

Condition Browse Module

ID	Term
D006319	Hearing Loss, Sensorineural

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

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Benefit Ease of Communication

Title	Measurements
	OG00012.7± 19.09 OG00113.18± 13.60

Benefit Background Noise

Title	Measurements
	OG00011.17± 22.98 OG00112.22± 19.94

Benefit Reverberant Room

Title	Measurements
	OG00011.43± 22.32 OG00112.49± 16.76

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Estimate Comment	Non-Inferiority Type	Non-Inferiority Comment
OG000 OG001	Check for interaction effect for Ease of Communication Subscale (EC) The statistical analysis method was a repeated-measures ANOVA in which: order is a "between-subjects" effect - i.e., each subject has just one order treatment is a "within-subjects" effect - i.e., each subjects has both treatments because of the cross-over design the interaction term treatment x order is a "within-subjects" effect. The rm-ANOVAs generates a nuisance p-value: that of the interaction effect.	ANOVA		0.38	p<0.05 would show that there is an interaction effect i.e. results would differ depending on the order in which the participants wore the hearing aids								Other	The rm-ANOVA model fitted for the primary analysis was run to confirm if there is a significant interaction for treatment and order. This confirmation of the absence of an interaction effect is needed to validate the pooling of the two periods of Web-App treatment and the two periods of Standard-of-Care treatment, respectively.
OG000 OG001	Check for interaction effect for Background Noise Subscale (BN) The statistical analysis method was a repeated-measures ANOVA in which: order is a "between-subjects" effect - i.e., each subject has just one order treatment is a "within-subjects" effect - i.e., each subjects has both treatments because of the cross-over design the interaction term treatment x order is a "within-subjects" effect. The rm-ANOVAs generates a nuisance p-value: that of the interaction effect.	ANOVA		0.79	p<0.05 would show that there is an interaction effect i.e. results would differ depending on the order in which the participants wore the hearing aids								Other	The rm-ANOVA model fitted for the primary analysis was run to confirm if there is a significant interaction for treatment and order. This confirmation of the absence of an interaction effect is needed to validate the pooling of the two periods of Web-App treatment and the two periods of Standard-of-Care treatment, respectively.
OG000 OG001	Check for interaction effect for Reverberant Room Subscale (RV) The statistical analysis method was a repeated-measures ANOVA in which: order is a "between-subjects" effect - i.e., each subject has just one order treatment is a "within-subjects" effect - i.e., each subjects has both treatments because of the cross-over design the interaction term treatment x order is a "within-subjects" effect. The rm-ANOVAs generates a nuisance p-value: that of the interaction effect.	ANOVA		0.51	p<0.05 would show that there is an interaction effect i.e. results would differ depending on the order in which the participants wore the hearing aids								Other	The rm-ANOVA model fitted for the primary analysis was run to confirm if there is a significant interaction for treatment and order. This confirmation of the absence of an interaction effect is needed to validate the pooling of the two periods of Web-App treatment and the two periods of Standard-of-Care treatment, respectively.
OG000 OG001	Results for Ease of Communication Subscale. Null hypothesis: benefit(standard-of-care fit) - benefit(web-app-fit) < noninferiority margin for all subscales. Each subscale was analyzed using an rm-ANOVA in which the repeated factors are order & treatment; no between-group factors. Interaction term was order x treatment. ITT population includes 2 subjects who withdrew. It was concluded that their primary endpoint data was missing for cause and their APHAB benefit scores were imputed as 0.	ANOVA	repeated measures ANOVA where factors are order and treatment is device with patient as a random effect. Added interaction term of treatment and order	<0.0001	Threshold for statistical significance was p =0.05. p-value was calculated using the estimated difference of benefits, calculating a new t-statistic by subtracting the applicable non-inf. margin from the difference and dividing by standard error.	Mean Difference (Final Values)	0.44	2-Sided	95	-4.3	5.2	Difference calculated as benefit(standard-of-care fit) - benefit(web-app-fit)	Non-Inferiority	Non-inferiority tests compared the subject´s perceived hearing aid benefit when the hearing aid was standard-of-care fitted compared to Web-App fitted by the subject. The non-inferiority margins are the minimum clinically important differences on each of the 3 communication benefit subscales as described by Cox & Alexander (Ear and Hearing 1995;16;176-186). These literature values are as follows: Ease of Communication (EC): 26, Background Noise (BN): 27, Reverberant Room (RV): 28
OG000 OG001	Results for Background Noise Subscale. Null hypothesis: benefit(standard-of-care fit) - benefit(web-app-fit) < noninferiority margin for all subscales. Each subscale was analyzed using an rm-ANOVA in which the repeated factors are order & treatment; no between-group factors. Interaction term was order x treatment. ITT population includes 2 subjects who withdrew. It was concluded that their primary endpoint data was missing for cause and their APHAB benefit scores were imputed as 0.	ANOVA	repeated measures ANOVA where factors are order and treatment is device with patient as a random effect. Added interaction term of treatment and order	<0.0001	Threshold for statistical significance was p =0.05. p-value was calculated using the estimated difference of benefits, calculating a new t-statistic by subtracting the applicable non-inf. margin from the difference and dividing by standard error.	Mean Difference (Final Values)	0.97	2-Sided	95	-5.3	7.2	Difference calculated as benefit(standard-of-care fit) - benefit(web-app-fit)	Non-Inferiority	Non-inferiority tests compared the subject´s perceived hearing aid benefit when the hearing aid was standard-of-care fitted compared to Web-App fitted by the subject. The non-inferiority margins are the minimum clinically important differences on each of the 3 communication benefit subscales as described by Cox & Alexander (Ear and Hearing 1995;16;176-186). These literature values are as follows: Ease of Communication (EC): 26, Background Noise (BN): 27, Reverberant Room (RV): 28
OG000 OG001	Results for Reverberant Room Subscale. Null hypothesis: benefit(standard-of-care fit) - benefit(web-app-fit) < noninferiority margin for all subscales. Each subscale was analyzed using an rm-ANOVA in which the repeated factors are order & treatment; no between-group factors. Interaction term was order x treatment. ITT population includes 2 subjects who withdrew. It was concluded that their primary endpoint data was missing for cause and their APHAB benefit scores were imputed as 0.	ANOVA	repeated measures ANOVA where factors are order and treatment is device with patient as a random effect. Added interaction term of treatment and order	<0.0001	Threshold for statistical significance was p =0.05. p-value was calculated using the estimated difference of benefits, calculating a new t-statistic by subtracting the applicable non-inf. margin from the difference and dividing by standard error.	Mean Difference (Final Values)	0.98	2-Sided	95	-4.6	6.5	Difference calculated as benefit(standard-of-care fit) - benefit(web-app-fit)	Non-Inferiority	Non-inferiority tests compared the subject´s perceived hearing aid benefit when the hearing aid was standard-of-care fitted compared to Web-App fitted by the subject. The non-inferiority margins are the minimum clinically important differences on each of the 3 communication benefit subscales as described by Cox & Alexander (Ear and Hearing 1995;16;176-186). These literature values are as follows: Ease of Communication (EC): 26, Background Noise (BN): 27, Reverberant Room (RV): 28