跳至主要内容
临床试验/CTRI/2022/10/046522
CTRI/2022/10/046522招募中不适用

Dozee as a Screening Tool for Sleep Apnea Detection and Classification

Turtle Shell Technologies Private Limited1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年10月19日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
To classify OSA severity based on the events detected by the Dozee device and

研究概览

简要总结

Obstructive Sleep Apnea (OSA) isa condition where the upper airway muscles relax resulting in airflowobstruction. Central Sleep Apnea is a condition where there is no evidence of completeobstruction but associated with reduced airflow and respiratory effort. Complexsleep apnea syndrome is a combination of both obstructive and central sleep apnea[1]. According to AASM manual apnea and hypopnea are defined as follows: Apneais flow limitation of more than or equal to 90% for atleast 10 seconds whereashypopnea is fall in signal excursion for more than or equal to 30% with 3% dropin saturation or 4% desaturation with an arousal.[2].

Polysomnography (PSG) is the goldstandard for detecting and assessing sleep apnea. It is performed overnight onsubjects in a resource-intensive specialised sleep centre, with the subjectswearing encephalography (EEG) electrodes, oronasal airflow sensors, thoracicand abdominal respiratory inductive plethysmography (RIP) belts,electrocardiography (ECG) sensors, an oxygen saturation finger-clip sensor, abody position sensor. This arrangement is very distracting to the individualand interferes with a decent night’s sleep. Furthermore, the PSG approachnecessitates the use of well-trained personnel and is a costly procedure [3]. BecausePSG is such a resource-intensive process, researchers are constantly lookingfor a simpler, less demanding, and intrusive way to screen for sleep apneafirst, and then propose PSG based on the severity of the screening test.

Ballistocardiography (BCG) is apromising approach that uses a non-invasive way to quantify the body motioncaused by blood ejection during each cardiac cycle [8]. BCG can be used to measurethe micro body motions produced during each cardiac contraction [9], as well asdetect breathing, snoring, and limb movements [4,5], and it can also be madeto work in a contact-free and non-wearable manner. Thus, BCG can be utilised toovercome the PSG system’s problems in a non-invasive way.

Dozee, developed by Turtle ShellTechnologies employs the concept of BCG. Dozee which is placed beneath themattress, detects micro-vibrations, from which proprietary algorithms deriveparameters such as heart rate, respiration, stress levels, restlessness, and sleepquality. It has been validated for heart rate (HR), respiration rate (RR), andmovement measurement. Contact accessories such as SpO2 are also included. Whencompared to the PSG, Dozee is far more user-friendly and comfortable for thesubjects. Since BCG is contactless there is very little risk to the patients.

  1. Jayaraj R, Mohan J, KanagasabaiA. A Review on Detection and Treatment Methods of Sleep Apnea. J Clin DiagnRes. 2017;11(3):VE01â€VE03.

  2. Gould GA, Whyte KF, Rhind GB, etal. The sleep hypopnea syndrome. Am Rev Respir Dis. 1988;137(4):895â€898.doi:10.1164/ajrccm/137.4.895.

  3. Wang, Z., Zhou, X., Zhao, W.,Liu, F., Ni, H., & Yu, Z. (2017). Assessing the severity of sleep apneasyndrome based on ballistocardiogram. PLOS ONE, 12(4), e0175351. doi:10.1371/journal.pone.0175351

  4. V. Saran, G. Kumar, U. Dhawan andG. Parchani, "Unsupervised Identification of Cardiac Contraction throughBallistocardiography," 2018 IEEE-EMBS Conference on Biomedical Engineeringand Sciences (IECBES), Sarawak, Malaysia, 2018, pp. 42-47, doi: 10.1109/IECBES.2018.8626652.

  5. Saran V., Kumar G., Parchani G.(2019) Unsupervised Extraction of Respiration Cycles ThroughBallistocardiography. In: Luhach A., Jat D., Hawari K., Gao XZ., Lingras P.(eds) Advanced Informatics for Computing Research. ICAICR 2019. Communicationsin Computer and Information Science, vol 1075. Springer, Singapore. https://doi.org/10.1007/978-981-15-0108-1\_14

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Adults of age 18-80
  • Able to provide written informed consent
  • Weight above 40 kgs
  • Recommended for a level 1 sleep lab study to test for sleep apnea.

排除标准

  • Weight above 150kg
  • A likely need to receive or undergo a procedure/care during the testing period
  • Have a pacemaker or defibrillator
  • A significant medical condition in the judgement of the investigator, which may compromise the study testing procedures.

结局指标

主要结局

To classify OSA severity based on the events detected by the Dozee device and

时间窗: At Baseline during patient enrolment in the study

compare it’s accuracy obtained from the gold standard test, Polysomnography (PSG)

时间窗: At Baseline during patient enrolment in the study

次要结局

  • 1. Dozee’s sensitivity in the classification of apnea according to standard American(Association of Sleep Medicine (AASM) classification)

研究者

申办方类型
Other [Medical Device]

研究点 (1)

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