Back to resultsEvaluation of New Diagnostic and Treatment Algorithm for Obstructive Sleep Apnea
Primary Purpose
Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
home sleep study
home CPAP titration (Autoset)
CPAP
Sponsored by
About this trial
This is an interventional health services research trial for Sleep Apnea focused on measuring Health utility, Home sleep study
Eligibility 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.
Sites / Locations
- The Chinese University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Other
Arm Label
3
1
2
Arm Description
usual practice
Outcomes
Primary Outcome Measures
Validity of the new home sleep study device compare with conventional inpatient sleep study
Secondary Outcome Measures
The relative efficacy between different algorithm
Failure rates in different algorithms which need to switch to the conventional algorithm
Full Information
NCT ID
NCT00425659
First Posted
January 22, 2007
Last Updated
July 9, 2009
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT00425659
Brief Title
Evaluation of New Diagnostic and Treatment Algorithm for Obstructive Sleep Apnea
Official Title
Evaluation of New Diagnostic and Treatment Algorithm for Obstructive Sleep Apnea in High Risk Population in Hong Kong
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Newer home sleep study device and algorithm provides an alternative for inpatient sleep study and improve the service provides to patients
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea
Keywords
Health utility, Home sleep study
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
3
Arm Type
Active Comparator
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Other
Arm Description
usual practice
Intervention Type
Device
Intervention Name(s)
home sleep study
Other Intervention Name(s)
different algorithm arrangement
Intervention Description
different in algorithm arrangement for diagnosing sleep apnea
Intervention Type
Device
Intervention Name(s)
home CPAP titration (Autoset)
Other Intervention Name(s)
Autoset
Intervention Description
continuous positive airway pressure device for treatment of sleep apnea
Intervention Type
Device
Intervention Name(s)
CPAP
Intervention Description
usual practice
Primary Outcome Measure Information:
Title
Validity of the new home sleep study device compare with conventional inpatient sleep study
Time Frame
1 year
Secondary Outcome Measure Information:
Title
The relative efficacy between different algorithm
Time Frame
1 year
Title
Failure rates in different algorithms which need to switch to the conventional algorithm
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kin W To, MBChB
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
Country
China
12. IPD Sharing Statement
Learn more about this trial
Evaluation of New Diagnostic and Treatment Algorithm for Obstructive Sleep Apnea
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