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Validation of Portable Monitoring Device for Diagnosing Sleep Apnea

Primary Purpose

Sleep Apnea

Status
Completed
Phase
Locations
China
Study Type
Observational
Intervention
ARES (Apnea Risk Evaluation System)
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Sleep Apnea

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients suspected of sleep apnea

Exclusion Criteria:

  • patient refuse to participate

Sites / Locations

  • The Chinese Univerisity of Hong Kong

Arms of the Study

Arm 1

Arm Type

Arm Label

observation

Arm Description

Outcomes

Primary Outcome Measures

validity of portable monitoring device

Secondary Outcome Measures

Full Information

First Posted
February 6, 2008
Last Updated
February 8, 2016
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT00628511
Brief Title
Validation of Portable Monitoring Device for Diagnosing Sleep Apnea
Official Title
A Validation Study of A New Diagnostic Device for Screening of Obstructive Sleep Apnea in High Risk Patient Population
Study Type
Observational

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
portable monitoring device could diagnose sleep apnea in high risk patients.
Detailed Description
This is a pilot study of another larger cohort investigating different algorithms in managing patients suspected of sleep apnea using portable monitoring device. Portable monitoring device is applied simultaneously with PSG to compare it's accuracy and validity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea

7. Study Design

Enrollment
175 (Actual)

8. Arms, Groups, and Interventions

Arm Title
observation
Intervention Type
Device
Intervention Name(s)
ARES (Apnea Risk Evaluation System)
Intervention Description
application of portable monitoring device with PSG
Primary Outcome Measure Information:
Title
validity of portable monitoring device
Time Frame
1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients suspected of sleep apnea Exclusion Criteria: patient refuse to participate
Study Population Description
patients suspected of sleep apnea
Sampling Method
Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
To K Wang, MBCHB
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Chinese Univerisity of Hong Kong
City
Hong Kong
Country
China

12. IPD Sharing Statement

Learn more about this trial

Validation of Portable Monitoring Device for Diagnosing Sleep Apnea

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