Hearing Loss Clinical Trials

Find Hearing Loss Clinical Trials Near You

A Randomised Controlled Trial to Evaluate the Effectiveness of Spatial-listening Training Delivered Via the Both EARS Training Package (BEARS) in Older Children and Teenagers With Bilateral Cochlear Implants

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of the BEARS clinical trial is to determine whether using the directional listening training delivered via the BEARS training package for 3-months alongside usual care compared to only receiving usual care improves speech-in-noise perception, hearing experiences, vocabulary and quality of life and reduces listening effort in young people between 8-16 years old (inclusive) with two cochlear implants. The participants will complete hearing assessments and questionnaires before completing the 3-month intervention. They will be followed up for the next 9-months through online and in-person appointments.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 16
Healthy Volunteers: f
View:

• Participant is a simultaneous or sequential bilateral cochlear implant user\*, who either has:

‣ Congenital severe/profound bilateral sensorineural hearing loss and have received at least one implant ≤ 36 months of age.

⁃ Progressive or acquired severe/profound bilateral sensorineural hearing loss (no age at implant restrictions for these patients) \*(a bilateral CI user is defined as a patient who uses both cochlear implant processors for a minimum of 6-hours per day over a month)

• Participant has stable programmes (defined as no longer using progressive programmes to work through).

• Participant has had at least two usual care checks/clinical appointments with stable aided levels (+/- 10 dB across 500Hz-4kHz) and no progressive maps to still work through, if they have had re-implantation of internal implant devices.

• Participant is aged 8-16 years, inclusive.

Locations
Other Locations
United Kingdom
The Midlands Hearing Implant Programme (Children's Service)
ACTIVE_NOT_RECRUITING
Birmingham
Yorkshire Auditory Implant Service
RECRUITING
Bradford
Emmeline Centre for Hearing Implants
RECRUITING
Cambridge
Scottish Cochlear Implant Programme
RECRUITING
Kilmarnock
Auditory Implants: Royal National ENT and Eastman Dental Hospitals
RECRUITING
London
Great Ormond Street Cochlear Implant Programme
RECRUITING
London
St George's Auditory Implant Service
RECRUITING
London
St Thomas' Hospital Hearing Implant Centre
RECRUITING
London
The Richard Ramsden Centre for Hearing Implants
RECRUITING
Manchester
North East Regional Cochlear Implant Programme
RECRUITING
Middlesbrough
Nottingham Auditory Implant Programme
RECRUITING
Nottingham
Oxford Auditory Implant Centre
RECRUITING
Oxford
University of Southampton Auditory Implant Service
RECRUITING
Southampton
Contact Information
Primary
Debi Vickers, PhD
dav1000@medschl.cam.ac.uk
01223 760683
Backup
Liz Arram, MSc
cctu.bears@ucl.ac.uk
Time Frame
Start Date: 2023-07-27
Estimated Completion Date: 2026-10-31
Participants
Target number of participants: 272
Treatments
Experimental: Both EARS training package (BEARS) and Usual Care
BEARS is a compilation of virtual reality games designed specifically for young people with bilateral cochlear implants. The hardware is either: A Head Mounted Display Device or an iPad with headphones.
Active_comparator: Usual Care
Usual care describes the routine rehabilitation received by participants via their implant centre.
Related Therapeutic Areas
Sponsors
Collaborators: University of Cambridge, University of Nottingham, Cambridge University Hospitals NHS Foundation Trust, Imperial College London, University College, London, University of Southampton, National Institute for Health Research, United Kingdom
Leads: Guy's and St Thomas' NHS Foundation Trust

This content was sourced from clinicaltrials.gov

Similar Clinical Trials