Snuggledown - Use of sensory blankets for children with autistic spectrum disorder
| ISRCTN | ISRCTN92655217 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92655217 |
| Secondary identifying numbers | 10090 |
- 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
Not provided at time of registration
Contact information
Prof Paul Gringras
Scientific
Scientific
Paediatric Neurology, 6th Floor
Evelina Children's Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom
Study information
| Study design | Randomised interventional treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Scientific title | Snuggledown - The use of sensory weighted blankets in children with autistic spectrum disorders and poor sleep: a randomised crossover study |
| 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(s) | South East London REC2, 24/08/2010, ref: 10/H0802/57 |
| Condition | Sleep disorders in paediatrics |
| Intervention | Sensory blanket (Southpaw Sensory Integration blanket) |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 01/04/2011 |
| Overall study end date | 01/10/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 15 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 100; UK Sample Size: 100 |
| 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 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
- England
- United Kingdom
Study participating centre
Evelina Children's Hospital
London
SE1 7EH
United Kingdom
SE1 7EH
United Kingdom
Sponsor information
Guy's and St.Thomas' NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
4th Floor
Thomas Guy House
Lambeth Palace Road
London
SE1 7EH
England
United Kingdom
| Website | http://www.guysandstthomas.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/00j161312 |
Funders
Funder type
Charity
Research Autism (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
