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Completed

NCT Number: NCT04875117

Fatigue and Hearing Loss.

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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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

NHS audiology department, Glasgow Royal Infirmary, Glasgow, United Kingdom

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hearing Aid

Device

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

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. Need for Cognition Scale (NFCS)

    Time frame: Once at baseline assessment only

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

  11. 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

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Registry information

Official study title

Investigating the Impact of Hearing Aid Fitting on Fatigue.

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 6, 2021
Registry last updated
May 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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