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

NCT ID: NCT04208672

Last Updated: 2019-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-16

Study Completion Date

2020-09-15

Brief Summary

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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

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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.

Conditions

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Validation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patient attending for PSG in Sleep Assessment Unit

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

Group Type EXPERIMENTAL

UMindSleep

Intervention Type DEVICE

CPAP titration will be provided for Obstructive Sleep Apneas Syndrome.

Interventions

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UMindSleep

CPAP titration will be provided for Obstructive Sleep Apneas Syndrome.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Dr. Zhang Jihui

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of psychiatry, Faculty of Medicine, The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Central Contacts

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Mandy Yu, MPH

Role: CONTACT

Phone: 852-39197593

Email: [email protected]

Other Identifiers

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CREC2018.501

Identifier Type: -

Identifier Source: org_study_id