Randomised controlled trial of online behavioural sleep intervention for children with epilepsy
Paul Gringras1, Aiswarya Anilkumar2, Lucy Bray3
1Department of Children's Sleep Medicine, Women's and Children's Institute, King's College London, London, UK.
Insights
An online sleep intervention for children with epilepsy showed some benefits, including reduced sleep onset latency and improved parental knowledge. However, it was not superior to standard care in overall sleep habits and had a high cost-effectiveness ratio.
Area of Science:
- Pediatric Neurology
- Sleep Medicine
- Health Economics
Background:
- Sleep problems are common in children with epilepsy.
- Effective interventions are needed to improve sleep quality and parental knowledge.
Purpose of the Study:
- To evaluate the clinical and cost-effectiveness of an online sleep intervention (COSI) for parents of children with epilepsy.
- To compare the COSI intervention against standard care (SC).
Main Methods:
- A multicentre, parallel-group, unblinded, randomised controlled trial.
- Recruited 85 children (aged 4-12 years) with epilepsy and sleep problems.
- Primary outcome: Children's Sleep Habits Questionnaire (CSHQ) at 3 months; cost-effectiveness at 6 months.
Main Results:
- The COSI group did not show significant superiority in CSHQ scores compared to SC (adjusted mean difference 3.00, p=0.05).
- The COSI group demonstrated a 16.5-minute reduction in sleep onset latency and increased parental knowledge.
- Only 53% of families accessed core intervention materials; the incremental cost-effectiveness ratio was £433,167 per QALY gained.
Conclusions:
- While the online intervention showed promise in improving objective sleep onset latency and parental knowledge, it did not significantly outperform standard care on the primary outcome.
- The intervention's cost-effectiveness was unfavorable at conventional thresholds.
- The underlying behavior change techniques may hold potential but require further optimization for accessibility and efficacy.
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.
