Objective sleep assessment in brace treated AIS patients

  • Research type

    Research Study

  • Full title

    Objective Assessment of Sleep in Brace Treated Patients with Adolescent Idiopathic Scoliosis (AIS)

  • IRAS ID

    349113

  • Contact name

    Ashley Cole

  • Contact email

    ashley.cole4@nhs.net

  • Sponsor organisation

    Sheffield Children's NHS Foundation Trust

  • Duration of Study in the UK

    1 years, 8 months, 31 days

  • Research summary

    Adolescent Idiopathic Scoliosis (AIS) is a curvature of the spine which occurs in teenagers and will often get worse with growth. There are 2 treatments available on the NHS for scoliosis. Smaller curves are treated in a plastic brace which is worn around the trunk. The “full-time” brace is the current back brace offered within the NHS, and this is usually prescribed to be worn for 20 hours a day. Although in many patients, it stops the curve reaching a size where surgery would be considered, the brace needs to be worn until growth has finished which is usually several years. It is recognised that this is a very difficult treatment for many young people. A new “night-time” brace, which is worn for around 9 hours whilst in bed at night is being studied in the NIHR funded BASIS study (IRAS No 291133). As this brace works whilst the patient is lying down, it can provide a stronger force to push the curve straighter. Whichever brace is used, if the curve progresses to 50 degrees or more, it will usually get bigger during adult life, so surgery is considered.
    This study will be the first to look at an objective assessment of sleep in brace treated AIS patients using wearable technology (CamNTech MotionWatch8) to measure total sleep time, sleep quality and sleep interruptions. The aim is to see whether patients in either brace have problems sleeping as assessed by the watch, whether these can be predicted from questionnaires and if it changes over time as patients get used to the brace. Any comparisons between night-time and full-time brace will need to occur once the BASIS study is completed.

  • REC name

    London - Stanmore Research Ethics Committee

  • REC reference

    24/PR/1315

  • Date of REC Opinion

    21 Nov 2024

  • REC opinion

    Further Information Favourable Opinion