Assessing Sleep and Circadian Rhythms in Primary Brain Tumors Patients: An Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Number of participants who wore the Fitbit device and complete questionnaires
研究概览
简要总结
Background:
Sleep disturbances are among the most common and severe symptoms reported by people with primary brain tumors (PBT). Smart wearable devices like Fitbits may be able to give detailed data about people s sleep and circadian rhythms. In this study, researchers will use Fitbits to learn more about sleep disruptions caused by tumors. This might help them design better future treatment and supportive care studies.
Objective:
To describe sleep disturbances and circadian disruption in people with PBT.
Eligibility:
English-speaking adults ages 18 and older who have PBT and are enrolled in the NIH study, Evaluation of the Natural History of and Specimen Banking for Patients with Tumors of the Central Nervous System. It is also known as the Natural History Study, trial #16C0151.
Design:
Participants will be screened over the telephone or in person. They will be asked about their medical history. Their cancer diagnosis will be confirmed through test results and pathology reports.
Participants will complete 4 surveys. The surveys take about 20 minutes to complete and will ask about:
The quality of their sleep
Their ability to fall asleep and stay asleep
How the quality of their sleep affects their daily activities
Their sleep hygiene and preferences
Participants will get a Fitbit. It looks like a watch and is worn on the wrist. They will connect the device to their smart phone to track sleep, heart rate, and activity. They will wear it for 1 month.
Participants will keep a daily sleep diary for 1 week. It will be sent via an electronic link. They will also repeat 2 of the surveys.
Participation will last for 1 month.
详细描述
Background:
Sleep disturbances are among the most common and severe symptoms reported in the Primary Brain Tumor (PBT)population and incidence rates are associated with oncologic therapies, particularly radiotherapy. Smart wearable devices have the potential to provide detailed information about sleep and circadian rhythms in human subjects with lower potential for data loss, as devices sync automatically and require less charging time. Measurement of sleep through smart wearables, also eliminates the difficulties of recording in a sleep clinic and allows for longer monitoring periods. Previous smart wearable research in healthy controls has found that the Fitbit Charge 3TM model performs better than actigraphy and is the most comparable to polysomnography, the gold standard of sleep detection. Currently, there are very few studies examining sleep or circadian rhythms with these devices in the PBT population.
Objectives:
To assess detection of sleep disturbances in PBT patients using the physiological sleep measurements attained from smart wearable devices as well as the correlation with self-reported sleep instruments.
Eligibility:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of participants who wore the Fitbit device and complete questionnaires
时间窗: End of Study
To describe the feasibility of using smart wearable devices, which quantify sleep stages, heart rate and activity, to measure the impact of oncologic therapy on sleep and circadian rhythms in the PBT population across disease trajectory
次要结局
- Measure sleep onset latency and sleep quality, efficiency and architecture(End of Study)
- Measure if patient chronotype is more pronounced in individuals with circadian disruption as measured by smart wearables(End of Study)
- Measure if patient chronotype is more pronounced in individuals with sleep disturbance as measured by smart wearables(End of Study)
- Measure comparability of clinical evaluation and at-home collection with sleep data from self-reported PROMIS questionnaires(End of Study)
- Measure correlation between physiological sleep data and self-reported sleep questionnaires(End of Study)
- Measure circadian rhythm variables to see if they dampen in patients with moderate to severe levels of sleep disturbances(End of Study)