Fatigue and Hearing Loss.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

129 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-04

Study Completion Date

2019-12-12

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.

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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.

Conditions

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Hearing Loss Fatigue

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Intervention

Participants who are due to receive their first-ever hearing aid(s) as part of their routine audiological care.

Hearing aid

Intervention Type DEVICE

One or two behind the ear hearing aids provided by the UK National Health Service.

Control

Participants with hearing loss who have not experienced any change in hearing aid status for at least 1 year.

No interventions assigned to this group

Interventions

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Hearing aid

One or two behind the ear hearing aids provided by the UK National Health Service.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* A self-reported hearing loss.
* Aged between 18 and 75 years old.

* Must already have an appointment arranged to receive a hearing aid for the first time.

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No