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Fatigue and Hearing Loss.

Completed
Conditions
Hearing Loss
Fatigue
Interventions
Device: Hearing aid
Registration Number
NCT04875117
Lead Sponsor
University of Nottingham
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 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
129
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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
InterventionHearing aidParticipants who are due to receive their first-ever hearing aid(s) as part of their routine audiological care.
Primary Outcome Measures
NameTimeMethod
Change in Fatigue Assessment Scale (FAS)Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.

A self-report measure of general fatigue.

Secondary Outcome Measures
NameTimeMethod
Change in the Multidimensional Fatigue Symptom Inventory - short form (MFSI-SF)Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.

A self-report measure of general fatigue.

Change in Social activity log (SAL)Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.

A self-report measure of social activity

Change in Auditory Lifestyle Demand Questionnaire (ALDQ)Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.

A self-report measure of auditory lifestyle

Craig Handicap Assessment and Reporting Technique (CHART)Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.

A self-report measure of work activity

Change in Vanderbilt Fatigue Scale (VFS)Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.

A self-report measure of listening-related fatigue.

Change in International Physical Activity Questionnaire short form (IPAQ)Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.

A self-report measure of physical activity

Change in Social Participation Restrictions Questionnaire (SPaRQ)Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.

A self-report measure of social participation restrictions

Need for Cognition Scale (NFCS)Once at baseline assessment only

A self-report measure of participants' enjoyment of cognitive challenges.

Change in Hearing Handicap Inventory for Adults (HHIA)Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.

A self-report measure of hearing handicap

Change in Listening Effort Assessment Questionnaire (LEAS)Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.

A self-report measure of listening effort

Change in Social Participation Questionnaire (SPQ)Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.

A self-report measure of social activity

Trial Locations

Locations (2)

NHS audiology department, Glasgow Royal Infirmary

🇬🇧

Glasgow, United Kingdom

University of Nottingham Hearing Sciences - Scottish Section

🇬🇧

Glasgow, United Kingdom

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