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

Haines, Rachel; White, Jennifer; Meakin, Garry; Tan, Wei; Hepburn, Trish; Leighton, Paul; Hall, Deborah; Sereda, Magdalena

Authors

Rachel Haines

Jennifer White

Garry Meakin

Wei Tan

Trish Hepburn

Paul Leighton

Deborah Hall

Magdalena Sereda



Contributors

Jennifer White
Project Member

Garry Meakin
Project Member

Wei Tan
Project Member

Trish Hepburn
Project Member

Paul Leighton
Researcher

Deborah Hall
Researcher

Magdalena Sereda
Researcher

Abstract

Background: The most common management strategy for tinnitus provided in UK audiology clinics is education and advice. This may also be combined with some form of sound therapy (e.g. digital hearing aids). While education and advice is generally provided by all clinics, there is a marked variability in provision of hearing aids that depends very much on clinical decisions. A recent Cochrane review concluded a lack of evidence to support or refute hearing aid use as a routine intervention for people with tinnitus and hearing loss. This lack of evidence is reflected in the inconsistency of tinnitus management in the UK. The aim of the HUSH trial is to determine the feasibility of conducting a definitive randomised controlled trial (RCT) of the effectiveness and cost-effectiveness of hearing aids for adults with tinnitus and hearing loss.

Methods: This is a multicentre randomised controlled feasibility trial. Up to 100 adults, aged 18 and over, presenting to 5 UK audiology clinics with a complaint of tinnitus and measurable hearing loss are being randomised to receive either: i) education and advice (Treatment as usual), or ii) education and advice with digital hearing aids. Feasibility outcomes are being collected around recruitment, retention, patient and healthcare professional acceptability and clinical outcome assessment. Outcomes are being collected via postal questionnaire at 12 weeks post baseline. A nested interview study will supplement clinical and other outcome data, providing a detailed understanding of participants’ and audiologists’ experience of both tinnitus management and the research processes.

Discussion: This feasibility trial will help us to (i) determine if it is feasible to conduct a multicentre RCT comparing treatment as usual and treatment as usual plus digital hearing aids, (ii) optimise the design of a future definitive, multicentre RCT, and (iii) inform which outcome(s) is/are relevant for patients. This work presents an important first step in determining the effectiveness of hearing aids as a tinnitus management strategy.

Trial registration: ISRCTN14218416

Journal Article Type Article
Publication Date Mar 27, 2020
Journal Pilot and Feasibility Studies
Publisher Springer Verlag
Peer Reviewed Peer Reviewed
Volume 6
Article Number 41
APA6 Citation Haines, R., White, J., Meakin, G., Tan, W., Hepburn, T., Leighton, P., …Sereda, M. (2020). Protocol for a multi-centre randomised controlled feasibility trial to assess effectiveness and cost effectiveness of digital hearing aids in patients with tinnitus and hearing loss (The HUSH Trial). Pilot and Feasibility Studies, 6, https://doi.org/10.1186/s40814-020-00582-5
DOI https://doi.org/10.1186/s40814-020-00582-5
Publisher URL https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-020-00582-5

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