NCT06589024进行中（未招募）不适用
Remote STATE Training for Insomnia in Older Adults - Phase II
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Sleep Efficiency
研究概览
简要总结
This study called rSTATE (Remote STATE Training for Insomnia in Older Adults) is a Phase II study to definitively evaluate the efficacy of a computerized cognitive training program (rSTATE) designed to improve sleep regulation and brain health and extend functional independence in older adults with insomnia.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who are 65 years of age or older. The inclusion age of ≥ 65 is in accordance with the FDA's Guideline for Industry Studies in Support of Special Populations (Geriatrics ICH-E7), which uses 65 as its cutoff for defining the geriatric population prone to insomnia.
- •Participants who have an Insomnia disorder diagnosis per DSM-V.
- •Participants who exhibit > 30 minutes sleep onset latency (SOL); and/or > 30 minutes wake after sleep onset (WASO).
- •Participants must be a US resident.
- •Participants who are fluent English speakers, per self-report, to ensure reasonable neuropsychological results on key assessments.
- •Participants must have adequate sensorimotor capacity to perform the program, including visual capacity adequate to read from a computer screen at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control a computer mouse or a tablet.
排除标准
- •Participants who score ≥ 4 on the Cognitive Function Index (CFI).
- •Participants who self-report vision or hearing difficulties that would interfere with the ability to complete the study tasks.
- •Participants with past or present psychosis, schizophrenia, or bipolar disorder. Participants with other untreated psychiatric disorder, including substance abuse/dependence disorders.
- •Participants with a seizure disorder.
- •Participants with untreated obstructive sleep apnea, diagnosis of other sleep disorders not attributable to a primary sleep regulation problem (e.g., restless legs syndrome).
- •Participants with a recent hospitalization, ongoing chemotherapy or other cancer treatment.
- •Participants enrolled in a concurrent clinical trial involving an investigational pharmaceutical, nutraceutical, medical device, or behavioral treatment (CBTi) in the last 12-months that could affect the outcome of this study, or concurrent engagement in another insomnia treatment, per self-report. However, participation in standard treatments not known to affect sleep (e.g., occupational therapy) or use of prescribed medications (e.g., anti-depressants) is allowable if stable on medications for > 3 months.
- •Participants who are using computer-based cognitive training programs or have used it within a month of the consent date.
研究组 & 干预措施
Experimental Treatment
Experimental
Computerized plasticity-based adaptive cognitive training requiring a total maximum of 36 treatment sessions, up to 5 sessions per week, ~36 minutes per session.
干预措施: Computerized Plasticity-Based Adaptive Cognitive Training (Other)
Active Comparator
Active Comparator
Sleep hygiene education
干预措施: Sleep Hygiene Education (Other)
结局指标
主要结局
Sleep Efficiency
时间窗: At 9 weeks and at 6 months
次要结局
- Wake After Sleep Onset(At 9 weeks and at 6 months)
- Sleep Onset Latency(At 9 weeks and at 6 months)
- Total Sleep Time(At 9 weeks and at 6 months)
- Total Time in Bed(At 9 weeks and at 6 months)
- Total Wake Time(At 9 weeks and at 6 months)
- Sleep Quality(At 9 weeks and at 6 months)
- Patient Health Questionnaire - 8 questions (PHQ-8) Score(At 9 weeks and at 6 months)
- Generalized Anxiety Disorder Questionnaire - 7 questions (GAD-7) Score(At 9 weeks and at 6 months)
- Percentage of Time Spent in Stage N1 Sleep(At 9 weeks)
- Percentage of Time Spent in Stage N2 Sleep(At 9 weeks)
- Percentage of Time Spent in Stage N3 Sleep(At 9 weeks)
- Percentage of Time Spent in REM Sleep(At 9 weeks)
- REM Latency(At 9 weeks)
- Gradual-Onset Continuous Performance Task Score(At 9 weeks and at 6 months)
- Complex Set-Shifting Score(At 9 weeks and at 6 months)
研究者
研究点 (1)
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