Generative AI for Sleep Promotion
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Fitbit-measured sleep duration
研究概览
简要总结
Sleep is a major public health concern in the United States. Major guidelines recommend that adults obtain at least 7 hours of sleep per night. More than 25% of U.S. adults do not meet this recommendation, and 14.5% report difficulty falling asleep on most days or every day during the past month. The investigators developed a low-cost, easily accessible sleep intervention using artificial intelligence (AI) technologies. The purpose of this study is to examine the effect of this intervention on sleep outcomes among U.S. adults.
详细描述
After providing informed consent, participants will complete a baseline assessment and then be randomized to either the AI chatbot intervention or a waitlist control. The intervention group will receive immediate access to the AI-powered sleep chatbot for 2 weeks, while the waitlist control group will continue their usual sleep habits without chatbot access. Following the post-intervention assessment, participants in the waitlist control group will receive access to the chatbot. Follow-up assessments will be conducted at 3 and 6 months after randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-75 years
- •had a raw score of 23 or higher on the Patient-Reported Outcomes Measurement Information System (PROMIS™) Sleep Disturbance
- •had a smartphone and be able to access the internet
- •willing and able to participate through text messages on a smartphone
- •able to read and understand English
排除标准
- •pregnant or lactating
- •concurrently participating in other research studies focused on lifestyle modifications
结局指标
主要结局
Fitbit-measured sleep duration
时间窗: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
Sleep duration will be measured objectively using Fitbit and defined as the total amount of time spent asleep during the primary sleep period, expressed in minutes.
次要结局
- Fitbit-measured sleep onset(Baseline, 2-week post-intervention, and 3- and 6-month follow-ups)
- Fitbit-measured sleep efficiency(Baseline, 2-week post-intervention, and 3- and 6-month follow-ups)
- Fitbit-measured wake after sleep onset(Baseline, 2-week post-intervention, and 3- and 6-month follow-ups)
- Perceived sleep quality(Baseline, 2-week post-intervention, and 3- and 6-month follow-ups)
- Daytime sleepiness(Baseline, 2-week post-intervention, and 3- and 6-month follow-ups)
- Sleep hygiene(Baseline, 2-week post-intervention, and 3- and 6-month follow-ups)
- Sleep environment(Baseline, 2-week post-intervention, and 3- and 6-month follow-ups)
- Number of awakenings(Baseline, 2-week post-intervention, and 3- and 6-month follow-ups)
- Light sleep duration(Baseline, 2-week post-intervention, and 3- and 6-month follow-ups)
- Deep sleep duration(Baseline, 2-week post-intervention, and 3- and 6-month follow-ups)
- Rapid eye movement sleep duration(Baseline, 2-week post-intervention, and 3- and 6-month follow-ups)
- Wake duration(Baseline, 2-week post-intervention, and 3- and 6-month follow-ups)
- Dysfunctional beliefs and attitudes about sleep(Baseline, 2-week post-intervention, and 3- and 6-month follow-ups)
- Perceived stress(Baseline, 2-week post-intervention, and 3- and 6-month follow-ups)
- Anxiety(Baseline, 2-week post-intervention, and 3- and 6-month follow-ups)
- Fatigue(Baseline, 2-week post-intervention, and 3- and 6-month follow-ups)