Validation of a Handy Sleep Monitoring Device: UMindSleep in Patients With Obstructive Sleep Apnea
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|ClinicalTrials.gov Identifier: NCT04208672|
Recruitment Status : Not yet recruiting
First Posted : December 23, 2019
Last Update Posted : December 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Validation||Device: UMindSleep||Not Applicable|
Obstructive sleep apnea (OSA) is a common sleep disorder in the general population with a prevalence ranging from 4-30%. OSA has been shown to be a significant risk factor of many cardiovascular diseases and mental disorders. However, OSA is a neglected problem in the general population. In addition, there is a significant unmet need for the treatment of OSA. One of the major reason for the under-diagnosis and under-treatment of OSA in the general population is a lack of reliable screening tool in detecting OSA. In this regard, several devices, such as ApneaLink, have been developed for the screening of OSA. However, as this kind of device only employs time in bed rather than actual sleep time to calculate the apnea index or desaturation index, they tend to underestimate the severity of sleep apnea. In this regard, it is timely need to develop and validate new device that can integrate the actual sleep time and apnea or desaturation events for the precise calculation of sleep apnea index or desaturation index.
The UMindSleep is a handy and wearable device to acquire EEG, heart rate, saturation, snoring and temperature. The signal will be uploaded to a smartphone through Bluetooth. By integrating these signals, the system can automatically analyze several key parameters by the algorithms, such as sleep stages and desaturation events.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Validation of a Handy Sleep Monitoring Device: UMindSleep in Patients With Obstructive Sleep Apnea|
|Estimated Study Start Date :||January 16, 2020|
|Estimated Primary Completion Date :||March 15, 2020|
|Estimated Study Completion Date :||September 15, 2020|
Experimental: Patient attending for PSG in Sleep Assessment Unit
Subjects referred to the SAU will be invited to participate into this study
CPAP titration will be provided for Obstructive Sleep Apneas Syndrome.
- sleep apnea [ Time Frame: 6 months ]The correlation of Sleep staging and Apnea-hyponea index measured by PSG and UMindSleep will be measured.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04208672
|Contact: Mandy Yu, MPHfirstname.lastname@example.org|
|Department of psychiatry, Faculty of Medicine, The Chinese University of Hong Kong|
|Hong Kong, Hong Kong|