Nextsense Brain-sensing Buds Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Participant-reported Sleep Quality
研究概览
简要总结
The purpose of this clinical trial is to explore how the presentation of sleep data impacts sleep quality, sleep-related behaviors (such as sleepiness), and sleep-related anxiety and stress. The study aims to answer the following key questions:
- Does receiving sleep-related feedback from a wearable sleep tracker affect an individual's mindset about sleep?
- How does the mindset about sleep influence sleep quality, sleepiness, and stress/anxiety levels related to sleep?
- Does the feedback on sleep data moderate the relationship between one's mindset about sleep and their sleep quality?
Participants will:
- Be randomly assigned to receive different types of feedback about their sleep data to determine if the way sleep data is presented influences self-reported sleep quality, sleepiness, and sleep-related stress.
- During the baseline period (Weeks 1-2), complete daily and weekly surveys assessing their sleep habits, beliefs about sleep, anxiety, stress, and mindset regarding sleep.
- For Weeks 3-4, wear a Fitbit and Brain-Sensing earbuds, receiving daily feedback on their sleep.
- At the end of the study, provide feedback on their experience using the devices. Participants may choose to return the devices or keep them after the study concludes.
详细描述
With the growing prevalence of sleep-tracking wearables available to consumers, understanding the psychological and behavioral impacts they have on users is important. Recent advancements in wearable technology allow for monitoring various sleep parameters, providing users with extensive data on their sleep patterns. The study aims to examine how the presentation of sleep data influences user sleep quality, sleep-related behaviors, including sleepiness, and sleep-related anxiety and stress. It will evaluate how the presentation of sleep data affects individuals' perceptions of sleep and related health issues, including daytime sleepiness and perceived sleep quality. Participants will receive sleep data feedback based on new methods assessed using Fitbit, brain-sensing earbuds, and other factors that might impact sleep. Additionally, the study seeks to offer valuable insights into sleep research, behavioral psychology, and wearable technology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All participants have the capacity to understand the informed consent for study participation and ability for subject to comply with the requirements of the study
- •Experiencing mild to moderate sleep disturbances, but without sleep disorder diagnosis
- •Naïve to sleep tracker use
- •Age 25-65
排除标准
- •Participants who have used any type of sleep tracker, such as Oura, Fitbit, Google Fit, Garmin Connect, or Apple Watch Sleep
- •Health conditions (i.e., cancer, cognitive impairment, panic disorder, post-traumatic stress disorder, sleep apnea, insomnia, restless leg syndrome, Parkinson's disease)
- •Use of Modafinil (Provigil), Methylphenidate (Ritalin), Sodium oxybate (Xyrem), Melatonin, Benadryl, Wakix, Sunosi or prescription medications for ADHD Enrollment in other sleep studies
- •Women who are pregnant or who are currently nursing/breastfeeding will be excluded from this study.
结局指标
主要结局
Participant-reported Sleep Quality
时间窗: 4 weeks (Week 1 - Week 4): measured at baseline, in daily surveys.
Measured via self-report using the 15-item Groningen Sleep Quality Scale, with scores ranging from 1 to 14. A score of 14 indicates poor sleep quality the previous night.
Sleep data - Total hours of sleep
时间窗: 2 weeks (Week 3 - Week 4): measured daily, sleep data tracked by Fitbit will be transmitted to the Alethios platform automatically once a day.
Total hours of sleep data tracked by Fitbit
Modified Karolinska Sleepiness Scale
时间窗: 4 weeks (Week 1 - Week 4): measured at baseline, in daily surveys.
Sleepiness, measured via self-report using the 1-item modified Karolinska Sleepiness Scale, ranges from 1 to 10, with 1 indicating extreme alertness, 3 alert, 5 neither alert nor sleepy, 7 sleepy but no difficulty remaining awake, 9 extremely sleepy, fighting sleep, and 10 extremely sleepy, falling asleep all the time.
Fitbit tracked Sleep Quality
时间窗: 2 weeks (Week 3 - Week 4): measured daily, sleep data tracked by Fitbit will be transmitted to the Alethios platform automatically once a day.
Fitbit sleep score, ranging from 0 to 100, indicates sleep quality: 90-100 is excellent, 80-89 good, 60-79 fair, and 0-59 poor, based on duration, disturbances, and restorative sleep.
次要结局
- Anxiety, Stress, and Mindset related to Sleep(4 weeks (Week 1 - Week 4): measured at baseline, in weekly surveys.)
- Dysfunctional Beliefs and Attitudes about Sleep 16-item(4 weeks (Week 1 - Week 4): measured at baseline, in weekly surveys.)
- Modified Insomnia Severity Index(Week 2 and Week 4: measured twice.)
- Satisfaction with sleep(Week 2 and Week 4: measured twice.)
- Sleep Problems Interference with Daily Functioning(Week 2 and Week 4: measured twice.)
- Pre-Sleep Arousal Scale(4 weeks (Week 1 - Week 4): measured at baseline, in weekly surveys.)