Fatigue and Hearing Loss.

April 30, 2021 updated by: University of Nottingham

Investigating the Impact of Hearing Aid Fitting on Fatigue.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

129

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Glasgow, United Kingdom, G312ER
        • NHS audiology department, Glasgow Royal Infirmary
      • Glasgow, United Kingdom, G312ER
        • University of Nottingham Hearing Sciences - Scottish Section

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intervention
Participants who are due to receive their first-ever hearing aid(s) as part of their routine audiological care.
Device: Hearing aid
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
Time Frame: Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
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)
Time Frame: Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
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)
Time Frame: Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
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)
Time Frame: Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
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)
Time Frame: Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
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)
Time Frame: Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
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)
Time Frame: Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
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)
Time Frame: Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
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)
Time Frame: Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
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)
Time Frame: Once at baseline assessment only
A self-report measure of participants' enjoyment of cognitive challenges.
Once at baseline assessment only
Change in Hearing Handicap Inventory for Adults (HHIA)
Time Frame: Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
A self-report measure of hearing handicap
Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nottingham

Investigators

  • Principal Investigator: Graham Naylor, Director

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2018

Primary Completion (Actual)

December 12, 2019

Study Completion (Actual)

December 12, 2019

Study Registration Dates

First Submitted

April 27, 2021

First Submitted That Met QC Criteria

April 30, 2021

First Posted (Actual)

May 6, 2021

Study Record Updates

Last Update Posted (Actual)

May 6, 2021

Last Update Submitted That Met QC Criteria

April 30, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17082

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

All anonymised raw data are to be made available upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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