Randomised controlled trial of online behavioural sleep intervention for children with epilepsy

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Abstract
We evaluated the clinical and cost effectiveness of an online sleep intervention (COSI) for parents of children with epilepsy. We conducted a multicentre, parallel-group, unblinded, randomised controlled trial. We recruited children aged 4–12 years with epilepsy and sleep problems through 26 UK outpatient clinics. Participants were randomly assigned (1:1) via a computer-generated minimisation algorithm. The primary outcome was the Children’s Sleep Habits Questionnaire (CSHQ) at three months. Cost-effectiveness was estimated at six months. We conducted intention to treat analyses. 85 children were enrolled (42 SC; 43 SC + COSI). At three months, the adjusted mean CSHQ difference between arms was 3.00 (95% CI 0.06–5.93; p = 0.05), indicating significant superiority of SC. Children in the SC + COSI group showed a mean 16.5-minute reduction in sleep onset latency by actigraphy and parents increased their knowledge. Only 23 (53%) families accessed the core intervention materials. Incremental mean cost of SC + COSI was £1,232 (95% credibility interval £535–£3,455) with a mean incremental Quality Adjusted Life Year (QALY) of 0.00 (95% CI -0.03 to 0.04), yielding an incremental cost-effectiveness ratio of £433,167 per QALY gained a (0.04 probability of being cost-effective at the £30,000/QALY threshold). Improved objective sleep onset latency and enhanced parental knowledge suggest that the underlying behaviour change techniques hold value.
Funding Information
  • National Institute for Health and Care Research (RP-PG-0615-20007)
  • National Institute for Health and Care Research (RP-PG-0615-20007)
  • National Institute for Health and Care Research (RP-PG-0615-20007)
  • National Institute for Health and Care Research (RP-PG-0615-20007)
  • National Institute for Health and Care Research (RP-PG-0615-20007)
  • National Institute for Health and Care Research (RP-PG-0615-20007)
  • National Institute for Health and Care Research (RP-PG-0615-20007)
  • National Institute for Health and Care Research (RP-PG-0615-20007)
  • National Institute for Health and Care Research (RP-PG-0615-20007)
  • National Institute for Health and Care Research (RP-PG-0615-20007)
  • National Institute for Health and Care Research (RP-PG-0615-20007)
  • National Institute for Health and Care Research (RP-PG-0615-20007)
  • National Institute for Health and Care Research (RP-PG-0615-20007)
  • National Institute for Health and Care Research (RP-PG-0615-20007)
  • National Institute for Health and Care Research (RP-PG-0615-20007)

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