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

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Unknown status
CT.gov ID
NCT04208672
Collaborator
(none)
100
1
1
8
12.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: UMindSleep
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Validation of a Handy Sleep Monitoring Device: UMindSleep in Patients With Obstructive Sleep Apnea
Anticipated Study Start Date :
Jan 16, 2020
Anticipated Primary Completion Date :
Mar 15, 2020
Anticipated Study Completion Date :
Sep 15, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patient attending for PSG in Sleep Assessment Unit

Subjects referred to the SAU will be invited to participate into this study

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

Outcome Measures

Primary Outcome Measures

  1. sleep apnea [6 months]

    The correlation of Sleep staging and Apnea-hyponea index measured by PSG and UMindSleep will be measured.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of psychiatry, Faculty of Medicine, The Chinese University of Hong Kong Hong Kong Hong Kong

Sponsors and Collaborators

  • Chinese University of Hong Kong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Zhang Jihui, Assistant Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT04208672
Other Study ID Numbers:
  • CREC2018.501
First Posted:
Dec 23, 2019
Last Update Posted:
Dec 23, 2019
Last Verified:
Dec 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 23, 2019