In collaboration with the NIHR Nottingham Hearing Biomedical Research Unit, a new trial into Tinnitus has opened at Nottingham University Hospitals.
Tinnitus describes any sound a person can hear which comes from inside their body rather than from an outside … Continue reading
AUT00063 (the study medicine) is an experimental new medicine for treating hearing disorders, such as loss of
hearing or tinnitus (a `ringing’ or buzzing noise in the ears). Hearing disorders are common in older people and have
recently become more common in young people. There are no licensed drugs available for hearing loss or tinnitus.
Reduced activity at certain sites in the brain (called “voltage-gated potassium channels”) has been linked to hearing
loss. The study medicine has been developed to treat the brain component of hearing disorders.
The main purpose of this study is to demonstrate a clinically relevant improvement in tinnitus severity after repeat
dosing of the study medicine or the placebo, in subjects with subjective tinnitus.
This will be determined by looking at a number of assessments (physical examinations, blood sampling, audiometric
assessments, questionnaires, etc.) done on patients experiencing noise or age-related tinnitus. Each patient will be
maximum 11 weeks in the study and will need to visit the clinic 5 times.
· Male or Female, English-speaking, subjects >18 years of age
· Able to understand and comply with the requirements of the study and provide signed informed consent.
· Experiencing stable tinnitus (consistent from day to day) with a Tinnitus Functional Index (TFI) score of ≥24 and ≤68
· Tinnitus has existed for not less than 6 months, and not more than 18 months (sub-acute tinnitus) at study start
· Hearing loss (Pure Tone Average (of thresholds at 250, 500, 1000, 2000 and 4000Hz) >20 and 90 days prior to study drug administration
Barrier methods plus spermicide in use at least 14 days prior to study drug administration or
[Exception: Female subjects of childbearing potential who are not sexually active will not be required to practice a
reliable method of contraception. These subjects may be enrolled at the Investigator’s discretion if they are counselled
to remain sexually inactive during the study and understand the possible risks in getting pregnant during the study.]
· Able to understand and comply with the requirements of the study, and sign Informed Consent forms.
1. History of hypersensitivity or reaction to any component of the test medication
2. Any acute disabling illness
3. Diabetes mellitus with an HbA1C >8% (64mmol/mol)
4. Previous cardiac rhythm abnormalities considered clinically significant
5. Severe hearing impairment such that verbal communication is unreliable
6. History of important major diseases deemed clinically significant at the time of the study by the Investigator and
which might be jeopardised by entering the study
7. Moderate or severe depression or generalised anxiety
8. Alcohol or drug abuse, deemed clinically significant by the Investigator
9. History of poor cooperation, non-compliance with medical treatment, or unreliability
10. Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at
least 5 half-lives (whichever is longer), of the investigational drug prior to consenting to study entry
11. Participation in hearing study within 3 months from last study visit
12. Use of central nervous system active drugs except analgesics
13. Non-study treatments for the management of tinnitus, severe insomnia, major depressive disorder, severe anxiety,
or post-traumatic stress disorder following baseline visit on D1
14. Central nervous system pathologies e.g. Multiple Sclerosis, Parkinson’s disease
15. Tinnitus as a concomitant symptom of a known otological condition.
16. Pulsatile tinnitus (rhythmical sounds that often beat in time with the heartbeat)
17. Intermittent tinnitus (comes and goes from one day to the next)
18. Surgery (e.g. stomach bypass) or medical condition that might affect absorption of medicines
19. Presence or history of relevant severe adverse reaction to any drug or a history of sensitivity to potassium channel
20. Blood pressure and heart rate (in seated position) at the screening examination outside the ranges specified
21. Corrected QTc interval Principal Investigator for this trial: Mr Matija Daniel
Research Ethics Committee Reference: 14/YH/1090
A study by the Nottingham Hearing Biomedical Research Unit found that the two best websites for assessing or managing tinnitus were rarely used by GPs, with just 2% logging on to access those pages. Continue reading
New Practice Guidance on Common Principles of Rehabilitation in Routine Audiology Services were launched in Nottingham last week by Professor Deborah Hall, Director of the NIHR Nottingham Hearing BRU during the Annual Conference of the British Society of Audiology. Continue reading
Gill suffers from tinnitus and is a Nottingham NIHR Hearing BRU trial participant. In this video, Gill describes her experiences of being part of a clinical trial with the Unit. Gill says: I became involved in the tinnitus trial because 23 years ago (when the tinnitus was diagnosed), the consultant I saw said “I don’t know much about tinnitus”. “We don’t really understand what it is all about”. And now, here and now, research is being done.” Continue reading
Nottingham researchers are testing whether emotions play a part in reducing the suffering of people with tinnitus. Hearing experts from Nottingham University Hospitals NHS Trust and the University of Nottingham are looking into how a range of personal and emotional … Continue reading
The C2HEAR (formerly known as HEAR-IT) research team led by Mel Ferguson and Prof Heather Wharrad (Nottingham Hearing BRU) were recently one of the top three finalists in the Software and Telehealth category of the East Midlands Innovation in … Continue reading
All NHS organisations are required to publish information on clinical trials regarding the 70 day benchmark of recruiting the first patient within 70 days of the valid submission and recruiting to time and target for commercial clinical trials.
How well we … Continue reading
COCHLEAR IMPLANTATION IN PATIENTS WITH SINGLE-SIDED DEAFNESS
Individuals with severe/profound hearing loss in one ear experience great difficulty to understand speech in
background noise and to localize sounds. The “standard of care” is a specialized hearing aid called a “contralateral
routing of signals” (CROS) system, which picks up sound at the deaf ear and delivers it to the opposite ear. This
enables the user to hear sounds at the poor side, but does not allow spatial separation of sound sources as all
sounds are perceived in one ear. Consequently, benefits are limited and uptake of CROS systems is low.
A cochlear implant (CI) is a surgically implanted hearing aid, and an approved treatment for bilateral deafness. There have been some recent reports, from outside the UK, of successful CI use in patients with single-side deafness
(SSD), where a CI can restore some hearing in the deaf ear. The aim of the proposed pilot study is to measure
outcomes from a cohort of such patients in detail, and to compare them with outcomes using a CROS system. The
study is funded by an NIHR grant, by Nottingham University Hospitals NHS Trust, the MRC Institute of Hearing
Research and by industry support from Cochlear Europe Ltd.
Adults with SSD will be recruited at five UK CI centres. They will be fitted with modern CROS systems for a 3 month trial, and then be given the option to proceed to cochlear implantation. 10 participants will be implanted. Detailed measures of sound localization, speech understanding in noise and a range of self-report questionnaires will be administered before treatment (baseline), and at intervals during the CROS trial and the first 9 months post implantation in order to obtain performance and healthutility comparisons between CROS and CI systems, which will potentially inform future NHS funding.
· Eighteen years of age or older at the time of entry to the study.
· Able and willing to undertake all assessments required by the study.
· Good understanding of written and spoken English.
· Normal anatomy of the cochlea and auditory system on MRI scanning.
· Medical fitness to undergo general anaesthesia.
· Poorer ear (ear to be implanted): (i) Acquired (post-lingual) severe to profound sensorineural hearing loss of
greater than 6 months and 90dB HL at 1 & 4 kHz, and no better than 65 dB HL at 500 Hz, (ii) Minimal benefit from hearing aids defined as scoring
less than 50% on Bamford-Kowal-Bench (BKB) sentences presented at 70 dB SPL.
· Better ear (contralateral ear): Normal or near-normal hearing. For the purposes of this study this is defined as hearing thresholds with a puretone average (PTA) of 30 dB HL at 500, 1000, and 2000 Hz.
· Evidence of middle-ear pathology based on otologic examination and immitance testing (NB: it is possible that
some such cases might be resolvable by medical/surgical treatment, so that the subject may be eventually included).
· Medical or psychological conditions that contraindicate undergoing surgery.
· Tinnitus as primary motivation for treatment.
· Abnormal anatomy of the cochlea that might prevent complete insertion of the electrode array and abnormalities of the
· Hearing loss of neural or central origin, including auditory neuropathy and neurofibromatosis type II.
· Additional handicaps that would prevent or restrict participation in the audiological evaluations.
· Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations which are
inherent to the surgical procedure and prosthetic device.
· Any known factor which would limit the benefit obtainable from a cochlear implant device.
Principal Investigator for this trial: Mr Andrew Marshall
Research Ethics Committee Reference: 12/EM/0378
The first issue of the Nottingham Hearing BRU newsletter features Dave Langer’s novel research investigating tonotopic maps. These display how the brain processes different audio frequencies.
The 9 million people in the UK with significant hearing loss have a greater hope of improving their condition with the announcement of a major NIHR award for a Nottingham Hearing & Deafness Biomedical Research Unit. The unit, based at … Continue reading
Gill suffers from tinnitus and is a Nottingham NIHR Hearing BRU trial participant. She describes her experiences of being part of a clinical trial with the Unit.
Peter Butler, a Nottingham NIHR Hearing BRU trial participant, describes his experiences of … Continue reading
Nottingham is home to two Biomedical Research Units (BRUs) awarded by the Department of Health. BRUs represent a large scale investment in infrastructure and promote a strong partnership between the NHS, academia and industry partners. This success have identified the … Continue reading