Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06560918
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-15
Brief Title:
Self-efficacy-based Auditory Rehabilitation with Over-the-Counter Hearing Aids
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Self-efficacy-based Auditory Rehabilitation to Optimize Real-world Outcomes with Over-the-Counter Hearing Aids a Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This goal of this study is to learn if a new audiology treatment process called the self-efficacy-based auditory rehabilitation SEBAR can improve confidence and success with over-the-counter OTC hearing aids
The main questions it aims to answer are
Can the SEBAR improve participants confidence related to managing their over-the-counter hearing aids
Can the SEBAR improve participants willingness to adopt over-the-counter hearing aids their satisfaction quality of life and their emotional state Researchers will compare these outcomes of the SEBAR with and without wearing OTC hearing aids
Participants will
Visit for one appointment to complete a few questionnaires without OTC hearing aids
Wear a pair of ITC hearing aids for a week and use an app to answer questions about their experiences
Visit for a second appointment to complete the same questionnaires with OTC hearing aids
The main questions it aims to answer are
Can the SEBAR improve participants confidence related to managing their over-the-counter hearing aids
Can the SEBAR improve participants willingness to adopt over-the-counter hearing aids their satisfaction quality of life and their emotional state Researchers will compare these outcomes of the SEBAR with and without wearing OTC hearing aids
Participants will
Visit for one appointment to complete a few questionnaires without OTC hearing aids
Wear a pair of ITC hearing aids for a week and use an app to answer questions about their experiences
Visit for a second appointment to complete the same questionnaires with OTC hearing aids
Detailed Description:
The proposed study will use a single-arm pre-post intervention research design to achieve both the aims Participants will complete two appointments Assessments in the first appointment will serve as the baseline unaided This will be followed by a week of OTC HA use and SEBAR implementation in their natural listening situations and the outcome measures will be completed again in appointment 2 aided to reflect the impact of wearing OTC HAs Scores on the outcome measures will be compared between the unaided and the aided conditions to answer both the aims Both the appointments in the proposed study will be completed in the shared and dedicated research spaces in the Department of Audiology and Speech Pathology College of Health Professions at the University of Arkansas for Medical Sciences The research proposal will be submitted for the universitys Institutional Review Boards approval Upon arrival participants will complete the consent process in which the PI will describe in detail all study procedures risks and benefits of the study and the lack of negative consequences should the participant choose to withdraw from the study or cease participation during data collection Once the consent form has been signed the participant will complete two appointments
Appointment 1 For each interested participant a standard audiometric procedure will be completed to confirm their eligibility Once the eligible participants consent preliminary measures will be completed Participants will then complete the unaided baseline outcome measures of hearing aid self-efficacy willingness to adopt HAs expected HA satisfaction current emotional state and quality of life At this time OTC HAs will be fitted to the participants and they will receive the SEBAR Participants will be instructed to use the HAs for at least 4 hours every day for the next week Finally the EMA app will be installed on their phone and its use at home will be demonstrated by the researcher
Appointment 2 At this appointment data from the EMA app during the one-week field trial will be stored HAs will be tested using the Verifit 2 to verify if they are providing the required amount of amplification at the participants preferred settings All the outcome measures conducted will be repeated to reflect the outcomes after using the OTC HAs for a week
Appointment 1 For each interested participant a standard audiometric procedure will be completed to confirm their eligibility Once the eligible participants consent preliminary measures will be completed Participants will then complete the unaided baseline outcome measures of hearing aid self-efficacy willingness to adopt HAs expected HA satisfaction current emotional state and quality of life At this time OTC HAs will be fitted to the participants and they will receive the SEBAR Participants will be instructed to use the HAs for at least 4 hours every day for the next week Finally the EMA app will be installed on their phone and its use at home will be demonstrated by the researcher
Appointment 2 At this appointment data from the EMA app during the one-week field trial will be stored HAs will be tested using the Verifit 2 to verify if they are providing the required amount of amplification at the participants preferred settings All the outcome measures conducted will be repeated to reflect the outcomes after using the OTC HAs for a week
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None