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CASE STUDY

Evaluating sensory bedding (The Fidgetbum) to aid chronic insomnia in children with autism spectrum disorders

UNMET NEED

Autism spectrum disorder (ASD) affects approximately 1/100 children in the UK. About 60-90% of children with ASD suffer with insomnia or other sleep problems. Insomnia and sleep disorders can have many negative impacts on children and their families, including poorer quality of life, poorer concentration, and/or behavioural problems.

The National Institute for Health and Care Excellence (NICE) recommends that first line treatments for insomnia and sleep disorders in children and young people should be educational and behavioural interventions, with melatonin prescribed as a second line treatment.

SOLUTION

Clinical evidence suggests that sensory pressure bedding may be more effective than melatonin at treating insomnia and sleep problems in children with ASD.

A small company called Fidgetbum developed a stretchy cotton sheet that wraps around a mattress and holds bedding in place, providing sensory pressure, with the aim of inducing relaxation and reducing arousal. The sheet is called the Fidgetbum.

NIHR CYP MedTech have partnered with Fidgetbum, Sheffield Children’s NHS Foundation Trust, Southampton Children’s Hospital, Oxford Brookes University, and Brunel University to evaluate the effectiveness of the Fidgetbum sheet on sleep quality and duration in children with ASD.

STAGE OF DEVELOPMENT BEFORE WORKING WITH NIHR CYP MEDTECH

Basic idea

Concept development

Prototype development

Prototype validation

Clinical testing

Regulatory approval

Manufacturing

Commercially available

SUPPORT PROVIDED BY NIHR CYP MEDTECH

Access to NHS and NIHR infrastructure

NIHR CYP MedTech facilitated access to the clinical sleep teams Sheffield Children’s NHS Foundation Trust and Southampton Children’s Hospital.

Study set up support

NIHR CYP MedTech supported the set up of the study and developed digital questionnaires and case report forms to simplify and streamline data collection.

Project management

NIHR CYP MedTech is providing day-to-day management of the project.

NEXT STEPS

Once data collection and analysis has concluded, the results of the study will be disseminated via:

  • Relevant local meetings;
  • Regional paediatric sleep and respiratory forums; and
  • Abstracts submitted to the British Sleep Society and British Thoracic Society conferences.

This initial study will also be used as the basis of a larger funding application to further examine the impact of the Fidgetbum sheet on the sleep of children with ASD.

IMPACT

This project addresses a significant unmet need for children with ASD. This research will help us understand the impact of the Fidgetbum sheet on children’s sleep quality and duration as well as on children’s, and their family’s, quality of life.

FUNDING

The pilot study is jointly funded by NIHR CYP MedTech and the Baily Thomas Foundation.

PARTNERS

 

Last updated: 18 May 2022