Validation of a Handy Sleep Monitoring Device: UMindSleep in Patients With Obstructive Sleep Apnea

Validation Clinical Trial

Official title:

Validation of a Handy Sleep Monitoring Device: UMindSleep in Patients With Obstructive Sleep Apnea

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04208672
• Other study ID #: CREC2018.501
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 16, 2020
• Est. completion date: September 15, 2020

Study information

• Verified date: December 2019
• Source: Chinese University of Hong Kong
• Contact: Mandy Yu, MPH
• Phone: 852-39197593
• Email: mandyyu[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a validation study recruiting subjects with and without obstructive sleep apnea. All subjects will undergo a nocturnal standard polysomnography and UMindSleep assessment. Sleep parameters, such as sleep stages and apnea UMindSleep software. Correlation in each parameter between PSG and events in polysomnography (PSG) will be scored according to the AASM criteria while the sleep parameters will be automatically scored by the UMindSleep will be analyzed to determine the magnitude of agreement between UMindSleep and PSG.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• complain of habitual snoring;

• AHI as measured by standard PSG > 5/hour

Exclusion Criteria:

• Aged 17 years old or below

• patients with narcolepsy and REM sleep behavior disorder

Related Conditions & MeSH terms

• Sleep Apnea, Obstructive
• Validation

Intervention

Device:
• UMindSleep
CPAP titration will be provided for Obstructive Sleep Apneas Syndrome.

Locations

Country	Name	City	State
Hong Kong	Department of psychiatry, Faculty of Medicine, The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sleep apnea	The correlation of Sleep staging and Apnea-hyponea index measured by PSG and UMindSleep will be measured.	6 months