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Clinical Trials/NCT04875117
NCT04875117
Completed
N/A

Investigating the Impact of Hearing Aid Fitting on Fatigue.

University of Nottingham2 sites in 1 country129 target enrollmentApril 4, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hearing Loss
Sponsor
University of Nottingham
Enrollment
129
Locations
2
Primary Endpoint
Change in Fatigue Assessment Scale (FAS)
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 4, 2018
End Date
December 12, 2019
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Change in Fatigue Assessment Scale (FAS)

Time Frame: Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.

A self-report measure of general fatigue.

Secondary Outcomes

  • 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.)
  • Change in Social activity log (SAL)(Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.)
  • Change in Auditory Lifestyle Demand Questionnaire (ALDQ)(Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.)
  • Craig Handicap Assessment and Reporting Technique (CHART)(Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.)
  • Change in Vanderbilt Fatigue Scale (VFS)(Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.)
  • Change in International Physical Activity Questionnaire short form (IPAQ)(Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.)
  • Change in Social Participation Restrictions Questionnaire (SPaRQ)(Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.)
  • Need for Cognition Scale (NFCS)(Once at baseline assessment only)
  • Change in Hearing Handicap Inventory for Adults (HHIA)(Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.)
  • Change in Listening Effort Assessment Questionnaire (LEAS)(Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.)
  • Change in Social Participation Questionnaire (SPQ)(Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.)

Study Sites (2)

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