Fatigue and Hearing Loss.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Investigating the Impact of Hearing Aid Fitting on Fatigue.

Conditions
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Fatigue, Hearing Loss

Intervention / Treatment
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* Device: Hearing aid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A self-reported hearing loss. Aged between 18 and 75 years old. Inclusion criteria for intervention group only: Must already have an appointment arranged to receive a hearing aid for the first time. Inclusion criteria for control group only: No change in hearing aid status (including new models) for the past 1 year. Exclusion Criteria: Non fluent English speakers. (To maintain validity of results as English language questionnaires are used) Inability to read (In order to complete the questionnaires). Inability to visit on multiple occasions over 7 months (e.g. can't be planning to move away from the area). Inability to give full informed consent. Primary complaint of tinnitus.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention<br>Participants who are due to receive their first-ever hearing aid(s) as part of their routine audiological care. | Device: Hearing aid<br>* One or two behind the ear hearing aids provided by the UK National Health Service.<br>|
| Control<br>Participants with hearing loss who have not experienced any change in hearing aid status for at least 1 year. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fatigue Assessment Scale (FAS) | A self-report measure of general fatigue. | Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Multidimensional Fatigue Symptom Inventory - short form (MFSI-SF) | A self-report measure of general fatigue. | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. | Once at baseline assessment only | 
| Change in Hearing Handicap Inventory for Adults (HHIA) | A self-report measure of hearing handicap | Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline. |