改变癫痫患者的睡眠、治疗和学习议程（CASTLE）睡眠-E 研究：一项比较罗伦氏癫痫儿童在线行为睡眠干预与标准护理的随机对照试验方案。

Changing Agendas on Sleep, Treatment and Learning in Epilepsy (CASTLE) Sleep-E: a protocol for a randomised controlled trial comparing an online behavioural sleep intervention with standard care in children with Rolandic epilepsy.

机构信息

Liverpool Clinical Trials Centre, Institute of Population Health, Faculty of Health and Life Sciences, University of Liverpool, Liverpool, UK.

Department of Nursing & Midwifery, Faculty of Health, Social Care and Medicine, Edge Hill University, Ormskirk, UK.

出版信息

BMJ Open. 2023 Mar 10;13(3):e065769. doi: 10.1136/bmjopen-2022-065769.

DOI:10.1136/bmjopen-2022-065769

PMID:36898757

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10008377/

Abstract

INTRODUCTION

Sleep and epilepsy have an established bidirectional relationship yet only one randomised controlled clinical trial has assessed the effectiveness of behavioural sleep interventions for children with epilepsy. The intervention was successful, but was delivered via face-to-face educational sessions with parents, which are costly and non-scalable to population level. The Changing Agendas on Sleep, Treatment and Learning in Epilepsy (CASTLE) Sleep-E trial addresses this problem by comparing clinical and cost-effectiveness in children with Rolandic epilepsy between standard care (SC) and SC augmented with a novel, tailored parent-led CASTLE Online Sleep Intervention (COSI) that incorporates evidence-based behavioural components.

METHODS AND ANALYSES

CASTLE Sleep-E is a UK-based, multicentre, open-label, active concurrent control, randomised, parallel-group, pragmatic superiority trial. A total of 110 children with Rolandic epilepsy will be recruited in outpatient clinics and allocated 1:1 to SC or SC augmented with COSI (SC+COSI). Primary clinical outcome is parent-reported sleep problem score (Children's Sleep Habits Questionnaire). Primary health economic outcome is the incremental cost-effectiveness ratio (National Health Service and Personal Social Services perspective, Child Health Utility 9D Instrument). Parents and children (≥7 years) can opt into qualitative interviews and activities to share their experiences and perceptions of trial participation and managing sleep with Rolandic epilepsy.

ETHICS AND DISSEMINATION

The CASTLE Sleep-E protocol was approved by the Health Research Authority East Midlands (HRA)-Nottingham 1 Research Ethics Committee (reference: 21/EM/0205). Trial results will be disseminated to scientific audiences, families, professional groups, managers, commissioners and policymakers. Pseudo-anonymised individual patient data will be made available after dissemination on reasonable request.

TRIAL REGISTRATION NUMBER

ISRCTN13202325.

摘要

简介

睡眠与癫痫之间存在既定的双向关系，但仅有一项随机对照临床试验评估了行为睡眠干预对癫痫儿童的有效性。该干预措施是成功的，但通过与父母进行面对面的教育课程来实施，这既昂贵又无法推广到人群层面。“改变癫痫睡眠、治疗和学习议程（CASTLE）睡眠-E 试验”通过比较罗德里格氏癫痫儿童在标准护理（SC）和标准护理增加新型、量身定制的父母主导的 CASTLE 在线睡眠干预（COSI）中的临床和成本效益来解决这一问题，该干预纳入了基于证据的行为学成分。

方法和分析

CASTLE Sleep-E 是一项基于英国的、多中心的、开放性标签、主动同期对照、随机、平行组、实用优效性试验。总共将从门诊诊所招募 110 名罗德里格氏癫痫儿童，并按照 1:1 比例随机分配至 SC 或 SC 增加 COSI（SC+COSI）。主要临床结局是父母报告的睡眠问题评分（儿童睡眠习惯问卷）。主要健康经济学结局是增量成本效益比（英国国家卫生服务和个人社会服务视角，儿童健康效用 9D 工具）。父母和儿童（≥7 岁）可以选择参与定性访谈和活动，以分享他们对参与试验和管理罗德里格氏癫痫睡眠的经验和看法。