Hearing Aids for Tinnitus with Hearing Loss (HUSH)

Conditions

Tinnitus with hearing loss Ear, Nose and Throat

Haines RH, Hepburn T, Tan W, Jackson C, Lathe J, White J, Almey C, Nicholson R, Stockdale D, Leighton P, James M, Sereda M.

2022-11-033 citations

10.1186/s40814-022-01188-9

Protocol for a multi-centre randomised controlled stand-alone feasibility trial to assess potential effectiveness and cost-effectiveness of digital hearing aids in patients with tinnitus and hearing loss (the HUSH trial)

Rachel Haines, Jennifer White, Garry Meakin, Wei Tan, Trish Hepburn et al. (12 authors)

Pilot and Feasibility Studies2020-03-275 citations

10.1186/s40814-020-00582-5

Interventions

Participants will be randomised in a 1:1 ratio to receive either digital hearing aids plus treatment as usual (intervention group) or treatment as usual alone (control group). Digital

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 18 or over with a clinical diagnosis of tinnitus with hearing loss, as defined by assessing audiologist 2. Providing written informed consent

Exclusion criteria

Exclusion criteria: 1. Tinnitus of a medically treatable origin 2. Previous use of a hearing aid in the last 12 months 3. Use of any combination device or behind the ear sound generator 4. Inability to communicate in English 5. Started or stopped medication for anxiety/depression within the last 3 months

Design outcomes

Primary

Measure	Time frame
Feasibility outcomes for the trial have been defined to determine the feasibility and acceptability of running a future large main trial: 1. Recruitment: Outcomes to assess whether it would be possible to recruit to a definitive trial. This includes proportion of patients eligible for the trial, barriers to screening and recruitment, number and proportion of patients recruited and randomised, characteristics of recruited patients, hearing aid compliance, completeness of the collected data, components of TAU used across sites, re-referral rates. Interviews with recruiting audiologists towards the end of the recruitment period (12 months) 2. Acceptability: Outcomes to assess whether patients and clinicians would find the interventions and trial acceptable. This will include feedback from patients and clinicians regarding experience with the trial (e.g. conduct, design, barriers) and opinions of the intervention, hearing aid use compliance. Actual usage at 12 weeks compared to advised usage at baseline	—

Measure

Time frame

Feasibility outcomes for the trial have been defined to determine the feasibility and acceptability of running a future large main trial: 1. Recruitment: Outcomes to assess whether it would be possible to recruit to a definitive trial. This includes proportion of patients eligible for the trial, barriers to screening and recruitment, number and proportion of patients recruited and randomised, characteristics of recruited patients, hearing aid compliance, completeness of the collected data, components of TAU used across sites, re-referral rates. Interviews with recruiting audiologists towards the end of the recruitment period (12 months) 2. Acceptability: Outcomes to assess whether patients and clinicians would find the interventions and trial acceptable. This will include feedback from patients and clinicians regarding experience with the trial (e.g. conduct, design, barriers) and opinions of the intervention, hearing aid use compliance. Actual usage at 12 weeks compared to advised usage at baseline

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Secondary

Measure	Time frame
1. Assessment: Outcomes to help identify the most appropriate primary outcome for a definitive trial, including patient opinion of relevance of patient reported outcome measures, distribution of patient reported outcome measures at baseline and 12 weeks 2. Safety: Collection of data to capture exacerbation of symptoms at 12 weeks 3. Patient reported outcome measures will inform choice of primary outcome for the main trial: 3.1. Severity of tinnitus, measured using Tinnitus Functional Index (TFI) at baseline and 12 weeks 3.2. Effects of hearing impairment and social adjustment, measured using Hearing Handicap Inventory for the Elderly (HHIE) at baseline and 12 weeks 3.3. General health status, measured using Health Utilities Index Mark 3 (HUI3) at baseline and 12 weeks 3.4. Depression and anxiety, measured using Hospital Anxiety and Depression Scale (HADS) at baseline and 12 weeks 3.5. Symptoms that the participant consider most important, measured using Measures Yourself Medical Outcome Profile (MYMOP) at baseline and 12 weeks 3.6. Health-related quality of life, measured using EQ5D5L at baseline and 12 weeks 3.7. Participant reported improvement in tinnitus and hearing, measured using Global Rating of Change Score at 12 weeks 4. The feasibility of collecting data for a health economic evaluation will be captured through a healthcare resource use questionnaire at 12 weeks	—

Measure

Time frame

1. Assessment: Outcomes to help identify the most appropriate primary outcome for a definitive trial, including patient opinion of relevance of patient reported outcome measures, distribution of patient reported outcome measures at baseline and 12 weeks 2. Safety: Collection of data to capture exacerbation of symptoms at 12 weeks 3. Patient reported outcome measures will inform choice of primary outcome for the main trial: 3.1. Severity of tinnitus, measured using Tinnitus Functional Index (TFI) at baseline and 12 weeks 3.2. Effects of hearing impairment and social adjustment, measured using Hearing Handicap Inventory for the Elderly (HHIE) at baseline and 12 weeks 3.3. General health status, measured using Health Utilities Index Mark 3 (HUI3) at baseline and 12 weeks 3.4. Depression and anxiety, measured using Hospital Anxiety and Depression Scale (HADS) at baseline and 12 weeks 3.5. Symptoms that the participant consider most important, measured using Measures Yourself Medical Outcome Profile (MYMOP) at baseline and 12 weeks 3.6. Health-related quality of life, measured using EQ5D5L at baseline and 12 weeks 3.7. Participant reported improvement in tinnitus and hearing, measured using Global Rating of Change Score at 12 weeks 4. The feasibility of collecting data for a health economic evaluation will be captured through a healthcare resource use questionnaire at 12 weeks

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Countries

England, United Kingdom, Wales

Outcome results

None listed