STATE Trial: SusTained Attention Training to Enhance Sleep
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Sleep duration obtained by sleep diary
研究概览
简要总结
This study is a validation study to document the acceptability of the Tonic and Phasic Alertness Training (TAPAT) training program in older adults with chronic late-life insomnia. The goal of this study is to employ a computerized attention-training program, TAPAT, designed for chronic late-life insomnia in a randomized, controlled trial to assess feasibility and initial efficacy in this population.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be between ages 55 and
- •Participant must meet current diagnostic criteria for Primary Insomnia Disorder based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
- •Participant with hypertension must be undergoing treatment for this condition and on a stable medication regimen for hypertension for ≥ 8 weeks prior to screening.
- •Participant must be a fluent English speaker
- •Participant must have adequate visual, auditory, and motor capacity to use computerized intervention
- •Participant must be willing to wear Microsoft Band 2 watch to track sleep patterns
排除标准
- •Participants with cognitive impairment, delirium or dementia, or evidence of cognitive impairment from a pre-existing cause.
- •Participants with untreated psychiatric conditions, including substance abuse/dependence disorders, untreated obstructive sleep apnea, diagnosis of other sleep disorders (e.g., restless legs syndrome), recent hospitalization, ongoing chemotherapy or other cancer treatment, and concurrent engagement in another insomnia treatment.
- •Participants enrolled in another concurrent research study.
- •Participants who have difficulty performing assessments or comprehending or following spoken instructions, in the judgment of the screening clinician.
- •Participants using computer-based cognitive training programs or has used them within a month of the consent date.
研究组 & 干预措施
Experimental Treatment
Computerized plasticity-based adaptive cognitive training requiring a total maximum of 24 treatment sessions, up to 7 sessions per week, 36 minutes per session.
干预措施: Computerized Plasticity-Based Adaptive Cognitive Training (Other)
Active Comparator
Commercially available computerized training requiring a total maximum of 24 treatment sessions, up to 7 sessions per week, 36 minutes per session.
干预措施: Commercially available computerized training (Other)
结局指标
主要结局
Sleep duration obtained by sleep diary
时间窗: 4 months
Sleep efficiency and sleep duration scores on the Pittsburg Sleep Quality Index
时间窗: 4 months
Sleep duration obtained by actigraphy (Microsoft Band 2 watch)
时间窗: 4 months
次要结局
未报告次要终点