Interoception and Sleep: An exploratory study to evaluate relationship between interoception and sleep quality
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- 3. Evaluation of macrosleep architecture parameters such sleep stages duration, sleep stage percentage, sleep efficiency etc.
研究概览
简要总结
Thepresent study aims:
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To study therelationship between sleep variables and interoceptive neural correlates usingdozee sleep quality algorithm.
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To study thebiological and behavioural correlates of stress with subjective and objectivesleep variables
This is a single-armprospective study that assess introceptive awareness and concurrent sleep datafrom Dozee and the polysomnography system. It is an observational study that isconducted with healthy volunteers and not intended for diagnostic orinterventional purposes.
Dozee devicedeveloped by Turtle Shell Technologies Pvt. Ltd., is intended for contactlesscontinuous monitoring of vital parameters (HR and RR), and screening forabnormal changes in these parameters. The device uses the concept ofballistocardiography and deploys piezoelectric sensors to capture themicro-vibrations originating from cardiac contractions, upper respiratory tractactivity and body movements. This data is then analyzed by a proprietaryalgorithm and the values of the vital parameters are generated. The device isintended to be used to monitor individuals/patients greater than eighteen yearsof age (40 kg ≤ weight ≤ 120 kg) and can measure their vital signsduring sleep and resting state. The setup includes placing a sensor under themattress, and a bedside unit on a nearby flat surface. The other components ofthe setup are Power cords and Power adapter. Thus, a power outlet withsufficient plug sockets near the bed will be required.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Healthy volunteers of ages >20 years and <70 years within weight range 40 kg.
- •Provide informed consent for the participation in an overnight study at the sleep lab.
排除标准
- •Subject has any history of medical and sleep disorder syndrome, drug or alcohol dependence and not under any medication as assessed by personal interviews.
- •Volunteers of ages <20 years and >70 years outside of the weight range 40 kg.
- •Volunteers with disturbed sleep one night before the actual sleep recordings.
结局指标
主要结局
3. Evaluation of macrosleep architecture parameters such sleep stages duration, sleep stage percentage, sleep efficiency etc.
时间窗: At Baseline
4. Evaluation of EEG dynamics (the synchrony, frequency, spectrum, amplitude, coherence and topography of the frequency bands- alpha, beta, theta, delta and gamma) associated with sleep states.
时间窗: At Baseline
5. Evaluation of biological level of melatonin and cortisol before and after the sleep.
时间窗: At Baseline
2. Evaluating the impact of environment specifically light, sound and temperature on sleep quality
时间窗: At Baseline
1. Validation of Dozee sleep staging, breathing rate, heart rate variability and snore detection to sleep lab polysomnography-based assessment.
时间窗: At Baseline
次要结局
- NA(NA)
