Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001280897
Ethics application status
Approved
Date submitted
7/12/2012
Date registered
11/12/2012
Date last updated
11/12/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Traditional Chinese Medicine (TCM) constitution and the cardiovascular risks in patients with obstructive sleep apnea syndrome (OSAS).
Scientific title
For patients with obstructive sleep apnea syndrome, what kinds of constitution in Traditional Chinese Medicine (TCM) are they have, and what is the relationship between constitution in Traditional Chinese Medicine (TCM) and cardiovascular disease.
Secondary ID [1] 281631 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive sleep apnea syndrome 287917 0
Condition category
Condition code
Respiratory 288293 288293 0 0
Sleep apnoea
Cardiovascular 288294 288294 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observation: 1. constitution in Traditional Chinese Medicine (TCM), a constitution's classification which is defined in TCM method and use to evaluate patient's constitution; 2. status of sleepiness; 3. quality of life; 4. endothelial function; 5. severity of OSAS.
Participants are assessed at baseline only for about 9 hours (including an overnight sleep study)
Intervention code [1] 286166 0
Not applicable
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288469 0
% of TCM constitutional distribution by Constitution in Chinese Medicine Questionnaire (CCMQ)
Timepoint [1] 288469 0
Baseline
Secondary outcome [1] 300254 0
TCM examination (tongue, voice and pulse examination), as assessed by photograph, sound recorder and a pulse diagnostic tool
Timepoint [1] 300254 0
Baseline
Secondary outcome [2] 300280 0
status sleepiness, as assessed by the Epworth Sleepiness Scale (ESS)
Timepoint [2] 300280 0
Baseline
Secondary outcome [3] 300281 0
Quality of life, as assessed by the 36-Item short-form healthy survey (SF-36). The SF-36 questionnaire will be answered by patients. And the outcome will be presented as average scores in eight dimensions of SF-36.
Timepoint [3] 300281 0
Baseline
Secondary outcome [4] 300282 0
severity of OSAS, as assessed by polysomnography (PSG)
Timepoint [4] 300282 0
Baseline, and it will take one night (about 8 hours) to finish
Secondary outcome [5] 300283 0
24 hour blood pressure, as assessed by blood pressure monitoring watch
Timepoint [5] 300283 0
Patients will be asked to wear the watch continuously for 24 hours from baseline (except taking a bath, it can remove the watch temporarily).
Secondary outcome [6] 300284 0
arterial stiffness, as assessed by pulse wave velocity (PWV)
Timepoint [6] 300284 0
Baseline
Secondary outcome [7] 300285 0
endothelium-dependent vasodilator function, as assessed by flow-mediated dilation (FMD)
Timepoint [7] 300285 0
Baseline
Secondary outcome [8] 300286 0
heart rate variability (HRV), as assessed by a pulse diagnostic tool
Timepoint [8] 300286 0
Baseline
Secondary outcome [9] 300287 0
inflammatory and endothelial function assessement, as assessed by blood test (including lipid profile, HSCRP, fibrinogen, adiponectin, homocysteine, MMP-9, TNF-a, VEGF, ET-1, e-selectin, iNOS)
Timepoint [9] 300287 0
Baseline
Secondary outcome [10] 300288 0
urine microalbumin
Timepoint [10] 300288 0
Baseline

Eligibility
Key inclusion criteria
patients with suspected obstructive sleep apnea syndrome
Minimum age
20 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
with underlying diseases of chronic obstructive pulmonary disease, myocardial infarction, heart failure, stroke, liver diseases, kidney diseases, neurogic and muscular disorders, metabolic diseases, immunosuppressed diseases, and malignancy

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/07/2011
Actual
16/09/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 4736 0
Taiwan, Province Of China
State/province [1] 4736 0

Funding & Sponsors
Funding source category [1] 286439 0
Government body
Name [1] 286439 0
Department of Industrial Technology (DoIT) of the Ministry of Economic Affairs
Country [1] 286439 0
Taiwan, Province Of China
Primary sponsor type
Hospital
Name
Taoyuan Chang Gung Memorial Hospital
Address
No.123, Dinghu Rd., Guishan Township, Taoyuan County 333, TAIWAN, R.O.C.
Country
Taiwan, Province Of China
Secondary sponsor category [1] 285225 0
None
Name [1] 285225 0
Address [1] 285225 0
Country [1] 285225 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288516 0
Chang Gung Medical Foundation Institutional Review Board
Ethics committee address [1] 288516 0
Ethics committee country [1] 288516 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 288516 0
Approval date [1] 288516 0
14/07/2011
Ethics approval number [1] 288516 0
100-1853B

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36450 0
Dr Yen-Lung, Chen
Address 36450 0
NO.123, DINGHU RD., GUISHAN TOWNSHIP, TAOYUAN COUNTY 333, TAIWAN, R.O.C.
Country 36450 0
Taiwan, Province Of China
Phone 36450 0
+886-3-3196200
Fax 36450 0
Email 36450 0
[email protected]
Contact person for public queries
Name 36451 0
Yen-Lung, Chen
Address 36451 0
NO.123, DINGHU RD., GUISHAN TOWNSHIP, TAOYUAN COUNTY 333, TAIWAN, R.O.C.
Country 36451 0
Taiwan, Province Of China
Phone 36451 0
+886-3-3196200
Fax 36451 0
Email 36451 0
[email protected]
Contact person for scientific queries
Name 36452 0
Yen-Lung, Chen
Address 36452 0
NO.123, DINGHU RD., GUISHAN TOWNSHIP, TAOYUAN COUNTY 333, TAIWAN, R.O.C.
Country 36452 0
Taiwan, Province Of China
Phone 36452 0
+886-3-3196200
Fax 36452 0
Email 36452 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.