NCT04875117

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 4, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 6, 2021

Completed
Last Updated

May 6, 2021

Status Verified

April 1, 2021

Enrollment Period

1.7 years

First QC Date

April 27, 2021

Last Update Submit

April 30, 2021

Conditions

Hearing LossFatigue

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • 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 Vanderbilt Fatigue Scale (VFS)

    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 International Physical Activity Questionnaire short form (IPAQ)

    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.

  • +6 more secondary outcomes

Study Arms (2)

Intervention

Participants who are due to receive their first-ever hearing aid(s) as part of their routine audiological care.

Device: Hearing aid

Control

Participants with hearing loss who have not experienced any change in hearing aid status for at least 1 year.

Interventions

Hearing aidDEVICE

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

Intervention

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

NHS audiology department, Glasgow Royal Infirmary

Glasgow, G312ER, United Kingdom

Location

University of Nottingham Hearing Sciences - Scottish Section

Glasgow, G312ER, United Kingdom

Location

MeSH Terms

Conditions

Hearing LossFatigue

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Wearable Electronic DevicesElectrical Equipment and SuppliesEquipment and SuppliesSensory Aids

Study Officials

  • Graham Naylor

    Director

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2021

First Posted

May 6, 2021

Study Start

April 4, 2018

Primary Completion

December 12, 2019

Study Completion

December 12, 2019

Last Updated

May 6, 2021

Record last verified: 2021-04

Locations

GB(2)