Hearing LossNCT04875117
Fatigue and Hearing Loss.
An observational study of Hearing Loss and Fatigue, run by University of Nottingham at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hearing Loss, Fatigue
- What is being tested?
- Hearing aid
- Type of treatment
- Medical device
- How many people
- 129 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 4 Apr 2018to 12 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- A self-reported hearing loss.
- Aged between 18 and 75 years old.
- Must already have an appointment arranged to receive a hearing aid for the first time.
- No change in hearing aid status (including new models) for the past 1 year.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
NHS audiology department, Glasgow Royal Infirmary
Glasgow, G312ER
University of Nottingham Hearing Sciences - Scottish Section
Glasgow, G312ER
About this study
Official title: 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.
Read the 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.
- Conditions
- Hearing Loss, Fatigue
- Being tested
- Hearing aid
- Medical subject headings
- Hearing Loss, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearing aidDevice
One or two behind the ear hearing aids provided by the UK National Health Service.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Participants who are due to receive their first-ever hearing aid(s) as part of their routine audiological care. Receives: Device: Hearing aid | |
| Control | Participants with hearing loss who have not experienced any change in hearing aid status for at least 1 year. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fatigue Assessment Scale (FAS)
A self-report measure of general fatigue.
Measured: Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
Secondary outcomes (11)
Change in the Multidimensional Fatigue Symptom Inventory - short form (MFSI-SF)
A self-report measure of general fatigue.
Measured: Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
Change in Vanderbilt Fatigue Scale (VFS)
A self-report measure of listening-related fatigue.
Measured: Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
Change in Listening Effort Assessment Questionnaire (LEAS)
A self-report measure of listening effort
Measured: Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
Change in International Physical Activity Questionnaire short form (IPAQ)
A self-report measure of physical activity
Measured: Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
Craig Handicap Assessment and Reporting Technique (CHART)
A self-report measure of work activity
Measured: Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
Change in Social Participation Restrictions Questionnaire (SPaRQ)
A self-report measure of social participation restrictions
Measured: Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
Change in Social Participation Questionnaire (SPQ)
A self-report measure of social activity
Measured: Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
Change in Social activity log (SAL)
A self-report measure of social activity
Measured: Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
Change in Auditory Lifestyle Demand Questionnaire (ALDQ)
A self-report measure of auditory lifestyle
Measured: Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
Need for Cognition Scale (NFCS)
A self-report measure of participants' enjoyment of cognitive challenges.
Measured: Once at baseline assessment only
Change in Hearing Handicap Inventory for Adults (HHIA)
A self-report measure of hearing handicap
Measured: Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start4 Apr 2018
- Primary completion12 Dec 2019
- Study completion12 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Graham Naylor, Principal investigator, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04875117
- Sponsor's protocol ID
- 17082
- Status last verified
- Apr 2021
- First submitted
- 27 Apr 2021
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All anonymised raw data are to be made available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Impact of Hearing Aid Fitting on Fatigue.
- ClinicalTrials.gov ID
- NCT04875117
- Acronym / sponsor ID
- 17082
- Conditions
- Hearing Loss, Fatigue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 4 Apr 2018 (actual)
- Primary completion
- 12 Dec 2019 (actual)
- Study completion
- 12 Dec 2019 (actual)
- First posted
- 6 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Device: Hearing aidParticipants who are due to receive their first-ever hearing aid(s) as part of their routine audiological care. |
| Control | – | –Participants with hearing loss who have not experienced any change in hearing aid status for at least 1 year. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- A self-reported hearing loss.
- Aged between 18 and 75 years old.
- Must already have an appointment arranged to receive a hearing aid for the first time.
- No change in hearing aid status (including new models) for the past 1 year.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hearing aidOne or two behind the ear hearing aids provided by the UK National Health Service. | Device | Intervention |
Primary outcome
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.
11 secondary outcomes
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.
Change in Vanderbilt Fatigue Scale (VFS)
Time frame: 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.
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.
Craig Handicap Assessment and Reporting Technique (CHART)
Time frame: 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.
Change in Social Participation Questionnaire (SPQ)
Time frame: 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.
Change in Auditory Lifestyle Demand Questionnaire (ALDQ)
Time frame: 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
Change in Hearing Handicap Inventory for Adults (HHIA)
Time frame: Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Individual participant dataSharing planned: Undecided. All anonymised raw data are to be made available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Graham Naylor principal investigator
Director
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss and Fatigue, run by University of Nottingham at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fatigue Assessment Scale (FAS) (time frame: Baseline, 3 months after baseline, 6 months after baseline and 9 months after baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2021.