SleepCogni V1
Research type
Research Study
Full title
Can the SleepCogni device (a handheld device that treats insomnia using biofeedback) improve sleep in children with chronic insomnia?
IRAS ID
342316
Contact name
Heather Elphick
Contact email
Sponsor organisation
SleepCogni
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
Around 30% children in mainstream and 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 most 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. Sleep apps have been designed, but their efficacy is lacking and none has been designed for children or young people. A solution is needed to help children to resolve sleep problems and to prevent them from escalating to the extent that they require specialist input.
SleepCogni is a CE marked device that uses biofeedback to aid sleep and is effective for adults with insomnia. Users’ comments included “I felt in control of my sleep”, “Shifts attention away from worry”, “I found it easier to relax my thinking”. We therefore believe that the device will be helpful for children, especially those with autism, anxiety and ADHD who have difficulty calming their thoughts around bedtime. The Adaptive Music for Sleep (AdMuS) is a new technology developed by The University of Sheffield that employs fading music to help sleep onset and quality that will be included in the SleepCogni platform.
In this observational study, we will recruit children and young people with chronic insomnia, as defined by the International Classification of Sleep Disorders (ICSD III) as difficulty getting to sleep or staying asleep at least 3 nights a week for at least 3 months. We will test whether SleepCogni is helpful in improving sleep and wellbeing parameters for these children and their caregivers. AdMuS will be used in a small subsample of children to test its effectiveness. We will also investigate the cost benefits of using SleepCogni in the NHS.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
25/PR/0632
Date of REC Opinion
26 Jun 2025
REC opinion
Further Information Favourable Opinion