Randomised controlled trial of online behavioural sleep intervention for children with epilepsy
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.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 85 participants or records.
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