Hearing loss study back in tune after COVID break
The REGAIN trial, funded by the EU Horizon 2020 programme and sponsored by Audion Therapeutics, was one of the first studies at University College London NHS Trust to restart after the pandemic, officially reopening on 29 May 2020.
Sensorineural hearing loss disables almost 500 million people worldwide. Irrespective of its cause and severity, hearing loss can have a large impact on people’s health and well-being. The most common cause of sensorineural hearing loss in adults is loss of inner ear hair cells due to ageing. The REGAIN trial is the first study of its kind investigating whether a drug that targets the regeneration of hair cells, injected into the ear, can restore hearing.
The study team at the University College London (UCL) Ear Institute and NIHR UCLH Biomedical Research Centre (BRC) have been pulling out all the stops to see patients in person again, and trial appointments have been delivered face-to-face since early July. These appointments were research only hospital visits and therefore required very careful and coordinated planning to align with the NHS clinical service re-opening.
Mark Sladen, Clinical Research Audiologist for the NIHR UCLH BRC, said: “We’ve been on quite the journey to get this study up and running again, and have had to think about how we can be flexible to meet the needs of our patients, while at the same time keeping both patients and staff safe, which is of paramount importance to us.”
Of the 30 patients recruited to this complex trial, the study team needed to see 18 remaining patients for their 12-month follow-up appointments from March onwards, when the pandemic hit. Seeing patients for the appointments was of critical importance to help establish the longer-term effects of the drug on hearing and if short-term effects were maintained over a longer period of time.
To make seeing patients again a reality, the study team had to present a case for reopening to the trust’s senior management team, but once support was secured, getting approval from the research and development department was clearly defined and straightforward.
Once this was sorted, attention turned to making the clinical area safe for both patients and staff.
“We worked with the hospital’s facilities management and infection control team to ensure we complied with all Personal Protective Equipment regulations, from the moment patients stepped through the entrance, having their hearing tests and completion of study visit,” Sladen explained.
“Some patients were reluctant to attend in person, so we provided lots of flexibility and multiple slots over July, August and later if required.”
Sladen added: “We helped with booking trains, given that many of the patients travel from a distance, and offered participants taxis so they could avoid tube journeys if these caused anxiety.”
The restart would not have happened without support from within UCLH, as Kim Airey, ENT Clinical Research Coordinator at UCL and UCLH, explained: “Clinical teams, especially those in Audiology, were very accommodating with our use of hearing booths and we worked collaboratively to accommodate both NHS patients and REGAIN patients.”
Chief Investigator, Director of the NIHR UCLH BRC Hearing Theme and NIHR CRN National Ear, Nose and Throat Specialty Lead, Professor Anne Schilder, added: “The clear directive from the NIHR surrounding the reopening of research supported our case with the UCLH senior management team and demonstrates the vital role research plays for patient care.
“It has been wonderful to experience how teams from the CRN, Joint Research Office and the Royal National ENT Hospital and Eastman Dental Hospital have worked effectively together to restart this ground-breaking trial.
“The approach has been very successful as the project is now near to completing the follow up appointments despite the pandemic. A big thank you to everyone involved.”