NCT04208672

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 23, 2019

Completed
24 days until next milestone

Study Start

First participant enrolled

January 16, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2020

Completed
Last Updated

December 23, 2019

Status Verified

December 1, 2019

Enrollment Period

2 months

First QC Date

September 3, 2019

Last Update Submit

December 19, 2019

Conditions

Validation

Outcome Measures

Primary Outcomes (1)

  • sleep apnea

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

    6 months

Study Arms (1)

Patient attending for PSG in Sleep Assessment Unit

EXPERIMENTAL

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

Device: UMindSleep

Interventions

UMindSleepDEVICE

CPAP titration will be provided for Obstructive Sleep Apneas Syndrome.

Patient attending for PSG in Sleep Assessment Unit

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • complain of habitual snoring;
  • AHI as measured by standard PSG \> 5/hour

You may not qualify if:

  • Aged 17 years old or below
  • patients with narcolepsy and REM sleep behavior disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hong Kong, Hong Kong

Location

Central Study Contacts

Mandy Yu, MPH

CONTACT

852-39197593mandyyu@cuhk.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 3, 2019

First Posted

December 23, 2019

Study Start

January 16, 2020

Primary Completion

March 15, 2020

Study Completion

September 15, 2020

Last Updated

December 23, 2019

Record last verified: 2019-12

Locations

HK(1)