Back to resultsValidation of a Handy Sleep Monitoring Device: UMindSleep in Patients With Obstructive Sleep Apnea
Primary Purpose
Validation
Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
UMindSleep
Sponsored by
About this trial
This is an interventional diagnostic trial for Validation
Eligibility Criteria
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
Sites / Locations
- Department of psychiatry, Faculty of Medicine, The Chinese University of Hong Kong
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patient attending for PSG in Sleep Assessment Unit
Arm Description
Subjects referred to the SAU will be invited to participate into this study
Outcomes
Primary Outcome Measures
sleep apnea
The correlation of Sleep staging and Apnea-hyponea index measured by PSG and UMindSleep will be measured.
Secondary Outcome Measures
Full Information
NCT ID
NCT04208672
First Posted
September 3, 2019
Last Updated
December 19, 2019
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04208672
Brief Title
Validation of a Handy Sleep Monitoring Device: UMindSleep in Patients With Obstructive Sleep Apnea
Official Title
Validation of a Handy Sleep Monitoring Device: UMindSleep in Patients With Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 16, 2020 (Anticipated)
Primary Completion Date
March 15, 2020 (Anticipated)
Study Completion Date
September 15, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Validation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient attending for PSG in Sleep Assessment Unit
Arm Type
Experimental
Arm Description
Subjects referred to the SAU will be invited to participate into this study
Intervention Type
Device
Intervention Name(s)
UMindSleep
Intervention Description
CPAP titration will be provided for Obstructive Sleep Apneas Syndrome.
Primary Outcome Measure Information:
Title
sleep apnea
Description
The correlation of Sleep staging and Apnea-hyponea index measured by PSG and UMindSleep will be measured.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mandy Yu, MPH
Phone
852-39197593
Email
mandyyu@cuhk.edu.hk
Facility Information:
Facility Name
Department of psychiatry, Faculty of Medicine, The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Learn more about this trial
Validation of a Handy Sleep Monitoring Device: UMindSleep in Patients With Obstructive Sleep Apnea
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