Condition category
Nervous System Diseases
Date applied
10/08/2011
Date assigned
10/08/2011
Last edited
23/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.researchautism.net/snuggledown

Contact information

Type

Scientific

Primary contact

Prof Paul Gringras

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

10090

Study information

Scientific title

Snuggledown - The use of sensory weighted blankets in children with autistic spectrum disorders and poor sleep: a randomised crossover study

Acronym

Study hypothesis

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

South East London REC2, 24/08/2010, ref: 10/H0802/57

Study design

Randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

Sleep disorders in paediatrics

Intervention

Sensory blanket (Southpaw Sensory Integration blanket)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Total sleep time based on actigraphy two weeks after each cross-over period

Secondary outcome measures

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)

Overall trial start date

01/04/2011

Overall trial end date

01/10/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned Sample Size: 100; UK Sample Size: 100

Participant 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

Recruitment start date

01/04/2011

Recruitment end date

01/10/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Evelina Children's Hospital
London
SE1 7EH
United Kingdom

Sponsor information

Organisation

Guy's and St.Thomas' NHS Foundation Trust (UK)

Sponsor details

4th Floor
Thomas Guy House
Lambeth Palace Road
London
SE1 7EH
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.guysandstthomas.nhs.uk/

Funders

Funder type

Charity

Funder name

Research Autism (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25022743

Publication citations

Additional files

Editorial Notes