Evaluation of New Diagnostic and Treatment Algorithm for Obstructive Sleep Apnea
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|ClinicalTrials.gov Identifier: NCT00425659|
Recruitment Status : Completed
First Posted : January 23, 2007
Last Update Posted : July 10, 2009
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea||Device: home sleep study Device: home CPAP titration (Autoset) Device: CPAP||Not Applicable|
Purpose: Assess different potential algorithms to improve the service and cost utility for diagnosis and treatment of obstructive sleep apnea syndrome (OSAS) in patients with high pretest probability in Hong Kong.
Hypothesis: Newer home sleep study device and algorithm provides an alternative for inpatient sleep study Design: Prospective randomized study Subject: High pretest probability of OSAS patients referred to a tertiary centre.
Study instruments: a portable sleep study device, AutoCPAP and inpatient sleep monitoring system.
Interventions: comparison between 3 different algorithms of health service for OSA patients would be made: conventional in-patient sleep study, empirical treatment and home sleep study.
Main outcome measures: The primary outcome is the validity of the home sleep study device compare to inpatient sleep study. The secondary outcomes are the relative efficacy of different algorithms and the numbers of failed procedures in each algorithm.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Evaluation of New Diagnostic and Treatment Algorithm for Obstructive Sleep Apnea in High Risk Population in Hong Kong|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||June 2009|
|Active Comparator: 3||
Device: home CPAP titration (Autoset)
continuous positive airway pressure device for treatment of sleep apnea
Other Name: Autoset
Device: home sleep study
different in algorithm arrangement for diagnosing sleep apnea
Other Name: different algorithm arrangement
- Validity of the new home sleep study device compare with conventional inpatient sleep study [ Time Frame: 1 year ]
- The relative efficacy between different algorithm [ Time Frame: 1 year ]
- Failure rates in different algorithms which need to switch to the conventional algorithm [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00425659
|The Chinese University of Hong Kong|
|Hong Kong, China|
|Principal Investigator:||Kin W To, MBChB||Chinese University of Hong Kong|