SLEEP SUPPORT FOR CHILDREN WITH NEURODEVELOPMENTAL DISORDERS

  • Research type

    Research Study

  • Full title

    CAN A SUPPORTIVE SLEEP-PRACTITIONER-LED INTERVENTION LEAD TO IMPROVED SLEEP, WELLBEING AND REDUCED MEDICATION PRESCRIBING FOR CHILDREN WITH NEURODEVELOPMENTAL DISORDERS AND CO-OCCURRING SEVERE SLEEP DIFFICULTIES?

  • IRAS ID

    290327

  • Contact name

    Heather Elphick

  • Contact email

    h.elphick@nhs.net

  • Sponsor organisation

    Sheffield Children's NHS Foundation Trust

  • Clinicaltrials.gov Identifier

    NCT05971212

  • Duration of Study in the UK

    1 years, 6 months, 0 days

  • Research summary

    Around 80% of children with neurodevelopmental disorders such as Attention Deficit Hyperactivity Disorder (ADHD) and autism are reported to have significant difficulties with sleep. This may be a problem with settling off to sleep, waking repeatedly in the night, or both.

    Often these children will be prescribed a medication called melatonin to help them sleep, but there is no strong evidence of its effectiveness in children, the long-term side effects are not known and prescriptions for this drug cost millions of pounds a year for the NHS. Many children continue to have persistent sleep problems despite taking melatonin.

    Sleep support programmes delivered by nurses and sleep practitioners are known to be effective and to give parents and young people long-term strategies for promoting sleep without the use of medication. However, sleep support services are not universally funded.

    In our feasibility study we will recruit 76 children with ADHD, autism or other neurodevelopmental disorder who have been prescribed and have been regularly taking melatonin for at least a year but still have severe sleep difficulties. We will help to improve the child’s sleep with a sleep practitioner support programme and, if possible, reduce the dose of melatonin or stop it completely if it is no longer needed.

    Using this design, we will be able to test whether a programme delivered by sleep practitioners will significantly improve sleep for children using a non-medical approach and in turn improve the health and well-being of the child and family and reduce melatonin prescribing, thereby saving NHS resources and the potential for long-term side effects. The study design will be delivered by Sheffield Children’s Hospital and supported by parent users, the Sleep Charity and Sheffield CCG. The results will be disseminated widely to local, regional and national groups as well as via social media.

  • REC name

    East of England - Cambridge South Research Ethics Committee

  • REC reference

    20/EE/0275

  • Date of REC Opinion

    23 Dec 2020

  • REC opinion

    Further Information Favourable Opinion