Fidgetbum for insomnia in children with ASD
Research type
Research Study
Full title
Does sleep quality and duration improve in children with autism with the use of ‘Fidgetbum’ compression sheet at night? A pilot study in two NHS tertiary children’s sleep services
IRAS ID
287539
Contact name
Heather Elphick
Contact email
Sponsor organisation
Sheffield Children's Hospital
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
Children with Autism Spectrum Disorder commonly suffer insomnia that affects their, and their family's, quality of life. Doctors often treat this with medication. Our clinical experience suggests that some children sleep better with sensory pressure bedding. We would like to study a commercially available compression sheet called Fidgetbum to see if it helps children sleep better, which children it helps most and what families and children think about using it. This will be a pilot study run by Sheffield Children's Hospital and Southampton Children's Hospital, two large children's sleep centres, with feedback from families to inform a later, bigger trial.
Questionnaires at the start of the study will record children's sleep habits and their parent's well being and will be completed remotely with or without the help of the research team. Children will then be randomly allocated to 2 weeks with their usual bedding or 2 weeks using the Fidgetbum and then they will swap to the alternative for a further 2 weeks.
Each night, parents will complete a sleep diary and a monitor will be placed under the mattress to assess pulse and breathing rate. During the second week with each type of bedding, children will wear a watch to measure sleep quality and length.
At the end, parents will be asked about their family's experience using the Fidgetbum and its effect on sleep.
It is thought that it will take 6 months to recruit all children and that each family's involvement in the study will be approximately 8 weeks. The entire project duration is anticipated to be 12 months.
All equipment will be sent out to the family at home and will be collected at the end of the study. Practical advice regarding set up will be delivered remotely via telephone or video calls.
REC name
London - Bromley Research Ethics Committee
REC reference
21/LO/0583
Date of REC Opinion
18 Oct 2021
REC opinion
Further Information Favourable Opinion