2016-08-012024-05-18https://scholars.lib.ntu.edu.tw/handle/123456789/708840摘要：兒童早期的睡眠問題與行為情緒障礙之形成有密切關係，且嚴重影響父母的睡眠及生活品質。癲癇兒的睡眠由於受到日夜間發作的影響，使其睡眠問題相較於同年齡的兒童更為普遍。不當的睡眠會誘發癲癇發作且不良睡眠習慣過去發現與較差的兒童癲癇預後有關，因而癲癇兒之睡眠及其對發作控制和健康相關生活品質之影響值得臨床關注。雖然目前歐美專家學者大力倡導兒童早期為建立良好睡眠習慣之關鍵時期，但全球目前還沒有任何已發表針對癲癇兒之睡眠介入性研究。本三年期研究目的為發展及測試一SHARE睡眠介入措施方案(Sleep, Health, and Research for Epilepsy; SHARE)。第一階段研究(08/2015-07/2016)預招募30位個案，將發展及前驅測試SHARE方案以初步評估其臨床可行性及可接受性和降低癲癇兒及其父母睡眠問題之有效性。第二階段研究(08/2016-07/2018)預招募160位個案，將利用前瞻性單一中心隨機分派之臨床試驗設計，評估SHARE方案於改善癲癇兒及其父母睡眠問題和健康相關生活品質、及癲癇兒發作頻率和行為情緒問題之短長期成效。本研究將於個案進入研究時(T0)，及隨機分派後三(T1)、六(T2)和十二個月時(T3)進行資料收集，活動紀錄器將用以提供客觀睡眠數據，資料分析將遵守治療意向分析法之原則，研究成果將提供日後推動睡眠介入方案落實於國內癲癇兒臨床照護之重要依據。<br> Abstract: Sleep problems are a major health concern for parents of young children. A recent large-scalecross-cultural survey involving 17 countries revealed that the prevalence of childhood sleep problems inTaiwan was one of the highest (71.65%) among the countries studied, and much higher than the already high20-30% reported in Western countries. Early childhood sleep problems are associated with overweight orobese children, poor language development, and parental distress and sleep disturbances. Sleep problems aremore prevalent and serious in children with epilepsy whose sleep can be disrupted by seizures occurringduring the night and/or during the day. Inadequate sleep has long been recognized as a trigger for seizure andpoor sleep habits have been associated with unfavorable outcomes in children with epilepsy. Attention tosleep in children with epilepsy as a result is critically important for seizure control and health-related qualityof life (HRQoL). Although early childhood has become increasingly acknowledged as the critical period toestablish adequate sleep habits, no sleep intervention studies have targeted children with epilepsy.The purpose of the three-year study is to develop and evaluate a SHARE sleep intervention program(sleep, health, and research for epilepsy; SHARE) for improving sleep and health in youth with epilepsy andtheir parents. Two major phases of the study are planned. Phase I: develop and test the feasibility,acceptability, and preliminary effectiveness of the SHARE program (08/2015-07/2016); Phase II: implementa prospective, one-center, parallel, single blind, fully-powered randomized controlled trial to evaluate theeffectiveness of the SHARE program delivered to parents of children with epilepsy (08/2016-07/2018). Equalnumber of epileptic children will be randomized to the experimental intervention or control with attention(usual care) groups. During Phase I trial, 30 children (15 per group) using the identical study protocol anddata retrial process at baseline (T0) and 3 months (T1) post-randomization will precede the full scoperandomized controlled trial. During Phase II trial, 160 children (80 per group) will be recruited and datacollection to evaluate the short-term and long-term impact of the SHARE program includes baseline atenrollment (T0), and 3 months (T1), 6 months (T2), and 12 months post-randomization (T3).Data analyses will be performed using the intention to treat approach. Outcome measures in this studyinclude objective and subjective sleep patterns, seizure frequencies, parental and child HRQoL, and childbehavioral and emotional symptoms. A separate repeated measure analysis of variance will be performed foreach sleep, health, and seizure outcome parameters in subjects with and without intervention. The researchteam chose this topic because little attention has been given to evaluating the complexities of sleep problemsand its adverse impact on health in youth with epilepsy and their parents. The educational material developedfrom this study can serve as a tool for helping parents of epileptic children to improve their knowledge aboutchildhood sleep behavior and problems. If successful, sleep-related knowledge can be delivered effectively toparents of children with epilepsy through this education material within our current structure of pediatricclinical practice in Taiwan.