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NCT00628511 Clinical Trial

Validation of Portable Monitoring Device for Diagnosing Sleep Apnea

Sleep Apnea Clinical Trial

Official title:
A Validation Study of A New Diagnostic Device for Screening of Obstructive Sleep Apnea in High Risk Patient Population

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00628511
Other study ID # 6902256
Secondary ID
Status Completed
Phase N/A
First received February 6, 2008
Last updated February 8, 2016
Start date January 2007
Est. completion date February 2008

Study information
Verified date February 2008
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority Hong Kong: Department of Health
Study type Observational

Clinical Trial Summary

portable monitoring device could diagnose sleep apnea in high risk patients.

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.

Recruitment information / eligibility
Status Completed
Enrollment 175
Est. completion date February 2008
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- patients suspected of sleep apnea

Exclusion Criteria:

- patient refuse to participate

Study Design

N/A

Related Conditions & MeSH terms

Intervention

Device:
• ARES (Apnea Risk Evaluation System)
application of portable monitoring device with PSG

Locations
Country Name City State
China The Chinese Univerisity of Hong Kong Hong Kong

Sponsors (1)
Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary validity of portable monitoring device 1 year No
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