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Evaluation of New Diagnostic and Treatment Algorithm for Obstructive Sleep Apnea

This study has been completed.
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00425659
First received: January 22, 2007
Last updated: July 9, 2009
Last verified: July 2009
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The relative efficacy between different algorithm [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Failure rates in different algorithms which need to switch to the conventional algorithm [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Doctor, CUHK
ClinicalTrials.gov Identifier: NCT00425659     History of Changes
Other Study ID Numbers: CRE-2006.404-T
Study First Received: January 22, 2007
Last Updated: July 9, 2009
Health Authority: Hong Kong: Department of Health

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 Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 22, 2013