EMERALD

  • Research type

    Research Study

  • Full title

    EMERALD Pilot study: Evaluating the Tolerability and Efficacy of a Remote Microphone (Assisted Listening Device) in Adult Patients with Mitochondrial Disease

  • IRAS ID

    316557

  • Contact name

    Grainne Gorman

  • Contact email

    grainne.gorman@ncl.ac.uk

  • Sponsor organisation

    The Newcastle upon Tyne Hospitals NHS Foundation Trust

  • Duration of Study in the UK

    1 years, 8 months, 31 days

  • Research summary

    Mitochondria are the ‘batteries’ of our cells that provide the energy we need. When they are faulty, it leads to mitochondrial disease.

    Currently there is no cure for mitochondrial disease. Treatments are limited and address symptoms rather than causes.

    Hearing loss is a common feature. It affects around 50 % of people with mitochondrial disease at some point.

    With hearing loss, we often think of ‘loudness’ of sound i.e., needing a sound to be louder to hear it. Many people wear hearing aids to make sounds louder (to amplify the noise).

    In mitochondrial disease hearing loss, loudness of the sound is not typically the only problem.

    People with mitochondrial disease hearing loss also have trouble understanding the clarity of speech. This is due to the way that their brain processes sound.
    Unfortunately, making the sound louder (e.g., with hearing aids), does not correct for this, as the distorted sound is amplified. Those affected still struggle to hear and understand speech.

    Sometimes Assistive Listening Devices (ALDs) are used to help communication.

    Wireless Remote Microphones (RMs) are one type of ALD. RMs pick-up the voice of a speaker and send it directly to your ears. The very latest types of RM can adapt to conversations that occur in background noise and over distance.

    In this pilot trial, we will test the Phonak Roger On RM.

    Twelve adults with mitochondrial disease and hearing loss will take part. They will use the ALD over six months.

    We will assess usability and effectiveness of the ALD and will measure each participant’s hearing and quality of life before, during, and at the end of this period. The aim is to see if the ALD is usable and improves hearing and quality of life.

    We hope this trial will lead to further, larger-scale research in this area.

  • REC name

    South Central - Oxford A Research Ethics Committee

  • REC reference

    23/SC/0120

  • Date of REC Opinion

    24 Apr 2023

  • REC opinion

    Favourable Opinion