Sleep disorders in paediatrics Nervous System Diseases Sleep disorders
Conditions
Interventions
Sensory blanket (Southpaw Sensory Integration blanket)
Sponsors
Guy's and St.Thomas' NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total sleep time based on actigraphy two weeks after each cross-over period | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
United Kingdom
Outcome results
None listed