Validation of Portable Monitoring Device for Diagnosing Sleep Apnea - Full Text View

Sponsored by:	Chinese University of Hong Kong
Information provided by:	Chinese University of Hong Kong
ClinicalTrials.gov Identifier:	NCT00628511

Purpose

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

Condition	Intervention
Sleep Apnea	Device: ARES (Apnea Risk Evaluation System)

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

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

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:

validity of portable monitoring device [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	175
Study Start Date:	January 2007
Study Completion Date:	February 2008
Estimated Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
observation	Device: ARES (Apnea Risk Evaluation System) application of portable monitoring device with PSG

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

patients suspected of sleep apnea

Criteria

Inclusion Criteria:

patients suspected of sleep apnea

Exclusion Criteria:

patient refuse to participate

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00628511

Locations

China
The Chinese Univerisity of Hong Kong
Hong Kong, China

Sponsors and Collaborators

Chinese University of Hong Kong

Investigators

Principal Investigator:

To K Wang, MBCHB

Chinese University of Hong Kong

More Information

Responsible Party:	The Hospital Authority ( To K W )
Study ID Numbers:	6902256
Study First Received:	February 6, 2008
Last Updated:	February 25, 2008
ClinicalTrials.gov Identifier:	NCT00628511
Health Authority:	Hong Kong: Department of Health

Study placed in the following topic categories:

Signs and Symptoms
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Respiration Disorders

Sleep Apnea, Obstructive
Dyssomnias
Sleep Disorders
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009