NCT03604380已完成不适用
STATE Trial: SusTained Attention Training to Enhance Sleep (Phase I- Remote Trial Arm)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 2
- 主要终点
- Sleep duration scores on the Pittsburg Sleep Quality Index
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) 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 remote, 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be 55 years of age or older.
- •Participant must meet criteria for clinical insomnia - moderate severity based on the Insomnia Severity Index.
- •Participant must be a fluent English speaker.
- •Participant must have adequate visual, auditory, and motor capacity to use computerized intervention.
- •Participant must have a computer and access to the Internet.
排除标准
- •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 using computer-based cognitive training programs or has used them within a month of the consent date.
结局指标
主要结局
Sleep duration scores on the Pittsburg Sleep Quality Index
时间窗: 6 months
Sleep efficiency scores on the Pittsburg Sleep Quality Index
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (2)
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