<p>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; <i>p</i> = 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.</p>

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

  • Paul Gringras,
  • Aiswarya Anilkumar,
  • Lucy Bray,
  • Bernie Carter,
  • Tony Coffey,
  • Georgia Cook,
  • Will A. S. Hardy,
  • Dyfrig A. Hughes,
  • Sylvine Lalnunhlimi,
  • Christopher Morris,
  • Holly Saron,
  • Lucy Stibbs-Eaton,
  • Catrin Tudur Smith,
  • Luci Wiggs,
  • Deb K. Pal

摘要

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.