Snuggledown - Use of sensory blankets for children with autistic spectrum disorder

ISRCTN	ISRCTN92655217
DOI	https://doi.org/10.1186/ISRCTN92655217
Protocol serial number	10090
Sponsor	Guy's and St.Thomas' NHS Foundation Trust (UK)
Funder	Research Autism (UK)

Submission date: 10/08/2011
Registration date: 10/08/2011
Last edited: 23/06/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Paul Gringras
Scientific

Paediatric Neurology, 6th Floor
Evelina Children's Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised interventional treatment trial
Secondary study design	Randomised controlled trial
Scientific title	Snuggledown - The use of sensory weighted blankets in children with autistic spectrum disorders and poor sleep: a randomised crossover study
Study objectives	The objective of this trial is to confirm (or refute) that a specially designed weighted blanket is effective in improving total duration of night-time sleep compared to a similar but non-weighted blanket in children with autistic spectrum problems No randomised clinical trials (RCT) have been published. Previous studies of weighted jackets have not reported any side effects. Care is required to ensure that the child is free to move/remove blanket at any point.(MCF, 2008) Anecdotal parent reported benefits include a reduced sleep latency time (ie: reduced time to fall asleep) and reduced number of awakenings throughout the night (ie: increased periods of continuous, un-interrupted sleep throughout the night).
Ethics approval(s)	South East London REC2, 24/08/2010, ref: 10/H0802/57
Health condition(s) or problem(s) studied	Sleep disorders in paediatrics
Intervention	Sensory blanket (Southpaw Sensory Integration blanket)
Intervention type	Other
Primary outcome measure(s)	Total sleep time based on actigraphy two weeks after each cross-over period
Key secondary outcome measure(s)	1. Sleep latency and efficiency (actigraphy) 2. Total sleep time and sleep latency by sleep diary 3. Parental assessment of sleep according to composite sleep disturbance index 4. Changes in behaviour (Aberrant Behaviour Checklist questionnaire) 5. Child's Visual Analogue Scale (VAS) perspective of sleep quality and acceptability of blanket 6. Sensory Behaviour Questionnaire (Green 2009)
Completion date	01/10/2012

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	5 Years
Upper age limit	15 Years
Sex	All
Target sample size at registration	100
Key inclusion criteria	1. Children aged 5 to 15 years and 10 months with a diagnosis of an autistic spectrum disorders (ASD), diagnosed by a community paediatrician, paediatric neurologist or paediatric neurodisability consultant 2. No plans to commence new medication known to influence behaviour or sleep 3. Diagnosis of impaired sleep as defined by a) not falling asleep within one hour of 'lights off' or 'snuggling down to sleep' at age-appropriate times and/or b) less than 7 hours of continuous sleep in 3 out of 5 nights 4. A total score of <4 on questions 18 to 20 on the Children's Sleep Habits Questionnaire indicating the likely absence of sleep apnoea 5. Parental English language sufficient to read and complete questionnaires and sleep diaries 6. Ability to start each night's sleep in own bed 7. Male and female participants
Key exclusion criteria	1. Children who are using a weighted blanket 2. Children whose parents are unlikely to be able to use the actigraph or complete sleep diaries or both 3. Children where there may be a problem of major non-concordance with blanket or actigraph 4. Currently participating in a conflicting clinical study 5. Epilepsy (uncontrolled or medication changes) 6. Cerebral palsy
Date of first enrolment	01/04/2011
Date of final enrolment	01/10/2012

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Evelina Children's Hospital

London
SE1 7EH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2014		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes