跳至主要内容
临床试验/CTRI/2022/10/046183
CTRI/2022/10/046183招募中不适用

Interoception and Sleep: An exploratory study to evaluate relationship between interoception and sleep quality

Turtle Shell Technologies Private Limited1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年10月10日最近更新:

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:

  1. To study therelationship between sleep variables and interoceptive neural correlates usingdozee sleep quality algorithm.

  2. 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)

研究者

申办方类型
Other [Medical Device]

研究点 (1)

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