Effects of Tablet Computer-based Cognitive Training in Patients With Idiopathic REM Sleep Behavior Disorder
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Korean version of the Consortium to Establish a Registry for Alzheimer's Disease Assessment Packet (CERAD-K) total score
研究概览
简要总结
To evaluate the effectiveness of tablet computer-based cognitive training in patients with idiopathic REM sleep behavior disorder.
详细描述
Rapid eye movement (REM) sleep behavior disorder (RBD) is a parasomnia characterized by abnormal movement to reproduce dreams and loss of skeletal muscle tension during REM sleep. Idiopathic RBD (iRBD) refers to the absence of any predisposing factors or comorbid neurological disorders. iRBD is considered the prodromal stage of alpha-synucleinopathy.
Through past studies, it has been confirmed that cognitive function decline has already occurred in a significant number of iRBD patients. However, there is still no treatment that can suppress or delay the onset of neurodegenerative diseases.
The cognitive function improvement effect of computerized cognitive training in the elderly and patients with mild cognitive impairment is known. However, the effect of cognitive training on improving cognitive function in iRBD patients has not been studied.
The investigators developed a program that allows patients to train cognitive functions in various domains by repeatedly performing tasks related to daily life activities. In addition, by loading the program on the tablet computer, it is possible to participate in the training easily at home using the touch screen without visiting the hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 60-80 years old who have been diagnosed with iRBD through nocturnal polysomnography according to the International Classification of Sleep Disorders 3rd Edition (ICSD-3) diagnostic criteria
- •Those who gave their written consent to participate in the study
排除标准
- •Patients with neurodegenerative diseases including Parkinson's disease, dementia, and multiple system atrophy
- •Patients with secondary causes of RBD
- •Patients with severe hearing, visual impairment, or motor impairment
- •Patients who have received cognitive training within the last year
结局指标
主要结局
Change in Korean version of the Consortium to Establish a Registry for Alzheimer's Disease Assessment Packet (CERAD-K) total score
时间窗: Change from baseline CERAD-K total score at 12 weeks
Z score of total 5 domains (attentive, memory, language, visuospatial and executive functions)
次要结局
- Change in CERAD-K visuospatial function score(Change from baseline CERAD-K visualspatial function score at 12 weeks)
- Change in Korean version of Montreal Cognitive Assessment (MoCA-K) score(Change from baseline MoCA-K score at 12 weeks)
- Change in resting electroencephalography (EEG) weighted phase lag index(Change from baseline EEG weighted phase lag index at 12 weeks)
- Change in event-related potential (ERP) reaction time(Change from baseline ERP reaction time at 12 weeks)
- Change in CERAD-K executive function score(Change from baseline CERAD-K executive function score at 12 weeks)
- Change in resting electroencephalography (EEG) power spectrum(Change from baseline EEG power spectrum at 12 weeks)
- Change in CERAD-K attention score(Change from baseline CERAD-K attention score at 12 weeks)
- Change in event-related potential (ERP) N2 amplitude(Change from baseline ERP N2 amplitude at 12 weeks)
- Change in event-related potential (ERP) time-frequency analysis(Change from baseline ERP time-frequency analysis at 12 weeks)
- Change in CERAD-K memory score(Change from baseline CERAD-K memory score at 12 weeks)
- Change in CERAD-K language score(Change from baseline CERAD-K language score at 12 weeks)
- Change in mini-mental status examination in the Korean version (MMSE-K) score(Change from baseline MMSE-K score at 12 weeks)
- Change in event-related potential (ERP) hit rate(Change from baseline ERP hit rate at 12 weeks)