Fatigue and Hearing Loss.

Fatigue Clinical Trial

Official title:

Investigating the Impact of Hearing Aid Fitting on Fatigue.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04875117
• Other study ID #: 17082
• Status: Completed
• Start date: April 4, 2018
• Est. completion date: December 12, 2019

Study information

• Verified date: April 2021
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: December 12, 2019
• Est. primary completion date: December 12, 2019
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Deafness
• Fatigue
• Hearing Loss

Intervention

Device:
• Hearing aid
One or two behind the ear hearing aids provided by the UK National Health Service.

Locations

Country	Name	City	State
United Kingdom	NHS audiology department, Glasgow Royal Infirmary	Glasgow
United Kingdom	University of Nottingham Hearing Sciences - Scottish Section	Glasgow

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Fatigue Assessment Scale (FAS)	A self-report measure of general fatigue.	Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
Secondary	Change in the Multidimensional Fatigue Symptom Inventory - short form (MFSI-SF)	A self-report measure of general fatigue.	Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
Secondary	Change in Vanderbilt Fatigue Scale (VFS)	A self-report measure of listening-related fatigue.	Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
Secondary	Change in Listening Effort Assessment Questionnaire (LEAS)	A self-report measure of listening effort	Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
Secondary	Change in International Physical Activity Questionnaire short form (IPAQ)	A self-report measure of physical activity	Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
Secondary	Craig Handicap Assessment and Reporting Technique (CHART)	A self-report measure of work activity	Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
Secondary	Change in Social Participation Restrictions Questionnaire (SPaRQ)	A self-report measure of social participation restrictions	Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
Secondary	Change in Social Participation Questionnaire (SPQ)	A self-report measure of social activity	Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
Secondary	Change in Social activity log (SAL)	A self-report measure of social activity	Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
Secondary	Change in Auditory Lifestyle Demand Questionnaire (ALDQ)	A self-report measure of auditory lifestyle	Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
Secondary	Need for Cognition Scale (NFCS)	A self-report measure of participants' enjoyment of cognitive challenges.	Once at baseline assessment only
Secondary	Change in Hearing Handicap Inventory for Adults (HHIA)	A self-report measure of hearing handicap	Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.