MedPath

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

Not Applicable
Completed
Conditions
Sleep disorders in paediatrics
Nervous System Diseases
Sleep disorders
Registration Number
ISRCTN92655217
Lead Sponsor
Guy's and St.Thomas' NHS Foundation Trust (UK)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
100
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

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath