Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04875117
Status:
COMPLETED
Last Update Posted:
2021-05-06
First Post:
2021-04-27
Brief Title:
Fatigue and Hearing Loss
Sponsor:
University of Nottingham
Organization:
University of Nottingham
Study Overview
Official Title:
Investigating the Impact of Hearing Aid Fitting on Fatigue
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
An intervention group and a control group will complete a battery of questionnaires at four time points to investigate the impact of first-ever hearing aid fitting on fatigue and associated variables The study is observational as all participants in the intervention group will already be receiving their first-ever hearing aid as part of their routine audiological care
Detailed Description:
Hearing Impairment leads to increased listening effort which could result in short andor long term fatigue Previous research has shown that people with a hearing loss score higher on fatigue questionnaires than people without a hearing loss Hearing Aid fitting has been shown to reduce fatigue in an objective measurement study however no reduction has been shown using subjective measurement To examine the effect of hearing aid fitting on fatigue a longitudinal study will be conducted A battery of questionnaires measuring fatigue listening effort daily activity need for cognition and hearing handicap as well as an objective hearing test will be conducted at 4 time points These time points will be a baseline assessment before hearing aid fitting 2 weeks after fitting 3 months after baseline 3 months after fitting and 6 months after fitting A control group with no change in hearing aid status will also be measured at these time points The study is observational as all participants in the intervention group will already be receiving their first-ever hearing aid as part of their routine audiological care This study monitors the effect of the hearing aid fitting
The general hypothesis is that hearing aid fitting will reduce fatigue More specifically it is expected that fatigue will increase immediately after fitting and then decrease by the 6 month time point It is also expected that social activity levels will increase after fitting and that individual differences in this activity change will explain some of the differences between participants in rate of change in fatigue It is predicted that high Need for Cognition and Hearing Handicap scores will increase the amount of change in fatigue for the intervention group 57 participants will be recruited for each group each participant being involved in the study for no more than 7 months with the study running for a total of 15 months The data will be analysed using multi-level analysis
The general hypothesis is that hearing aid fitting will reduce fatigue More specifically it is expected that fatigue will increase immediately after fitting and then decrease by the 6 month time point It is also expected that social activity levels will increase after fitting and that individual differences in this activity change will explain some of the differences between participants in rate of change in fatigue It is predicted that high Need for Cognition and Hearing Handicap scores will increase the amount of change in fatigue for the intervention group 57 participants will be recruited for each group each participant being involved in the study for no more than 7 months with the study running for a total of 15 months The data will be analysed using multi-level analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None