An observational study in Hearing Loss and Fatigue, sponsored by University of Nottingham. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-05-06.
Sponsored by University of Nottingham · Observational
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.
Hearing Impairment leads to increased listening effort which could result in short and/or 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.
1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.
This study's enrollment of 129 is above the median of 87 across 270 observational studies indexed under Hearing Loss.
Browse Hearing Loss studies →University of Nottingham is the lead sponsor of 455 studies on the registry; 77 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population are adults with hearing loss. The intervention group are those already due to receive their first-ever hearing aid as part of their routine audiological care, while the controls experience no change in hearing aid status for at least one year.
Inclusion Criteria:
Inclusion criteria for intervention group only:
Inclusion criteria for control group only:
Exclusion Criteria:
Participants who are due to receive their first-ever hearing aid(s) as part of their routine audiological care.
Device: Hearing aid
Participants with hearing loss who have not experienced any change in hearing aid status for at least 1 year.
One or two behind the ear hearing aids provided by the UK National Health Service.
Change in Fatigue Assessment Scale (FAS)
A self-report measure of general fatigue.
Time frame: Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
Change in the Multidimensional Fatigue Symptom Inventory - short form (MFSI-SF)
A self-report measure of general fatigue.
Time frame: Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
Change in Vanderbilt Fatigue Scale (VFS)
A self-report measure of listening-related fatigue.
Time frame: Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
Change in Listening Effort Assessment Questionnaire (LEAS)
A self-report measure of listening effort
Time frame: Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
Change in International Physical Activity Questionnaire short form (IPAQ)
A self-report measure of physical activity
Time frame: Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
Craig Handicap Assessment and Reporting Technique (CHART)
A self-report measure of work activity
Time frame: Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
Change in Social Participation Restrictions Questionnaire (SPaRQ)
A self-report measure of social participation restrictions
Time frame: Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
Change in Social Participation Questionnaire (SPQ)
A self-report measure of social activity
Time frame: Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
Change in Social activity log (SAL)
A self-report measure of social activity
Time frame: Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
Change in Auditory Lifestyle Demand Questionnaire (ALDQ)
A self-report measure of auditory lifestyle
Time frame: Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
Need for Cognition Scale (NFCS)
A self-report measure of participants' enjoyment of cognitive challenges.
Time frame: Once at baseline assessment only
Change in Hearing Handicap Inventory for Adults (HHIA)
A self-report measure of hearing handicap
Time frame: Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
Plan to share: Undecided — All anonymised raw data are to be made available upon request.
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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University of Nottingham