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Evaluation of New Diagnostic and Treatment Algorithm for Obstructive Sleep Apnea

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00425659
First Posted: January 23, 2007
Last Update Posted: July 10, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Chinese University of Hong Kong
  Purpose
Newer home sleep study device and algorithm provides an alternative for inpatient sleep study and improve the service provides to patients

Condition Intervention
Sleep Apnea Device: home sleep study Device: home CPAP titration (Autoset) Device: CPAP

Study Type: Interventional
Study Design: Allocation: Randomized
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Validity of the new home sleep study device compare with conventional inpatient sleep study [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 150
Study Start Date: January 2007
Study Completion Date: June 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 3 Device: home CPAP titration (Autoset)
continuous positive airway pressure device for treatment of sleep apnea
Other Name: Autoset
Experimental: 1 Device: home sleep study
different in algorithm arrangement for diagnosing sleep apnea
Other Name: different algorithm arrangement
2
usual practice
Device: CPAP
usual practice

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients with high pretest probability of OSAS, i.e. ESS > 10 or symptomatic patients, with BMI > 23 and/or cranial facial features associated with OSA, as assessed by the attending respiratory physician in the respiratory clinic.
  • Patients aged between 18-65 years who agree to participate in the study.

Exclusion Criteria:

  • Pregnant women
  • Patients who refuse signing consent of the study
  • Do not have high pretest probability of OSAS
  • Refuse to have home sleep study
  • Refuse any treatment offered; or
  • Could not comply with the set up of home study.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
China
The Chinese University of Hong Kong
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Kin W To, MBChB Chinese University of Hong Kong
  More Information

Responsible Party: Doctor, CUHK
ClinicalTrials.gov Identifier: NCT00425659     History of Changes
Other Study ID Numbers: CRE-2006.404-T
First Submitted: January 22, 2007
First Posted: January 23, 2007
Last Update Posted: July 10, 2009
Last Verified: July 2009

Keywords provided by Chinese University of Hong Kong:
Health utility
Home sleep study

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases