Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001285842
Ethics application status
Approved
Date submitted
11/12/2012
Date registered
12/12/2012
Date last updated
12/12/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Traditional Chinese Medicine (TCM) Constitution in patients with obstructive sleep apnea syndrome (OSAS) treated with continuous positive airway pressure (CPAP).
Scientific title
Among patients with obstructive sleep apnea syndrome, is the treatment with continuous positive airway pressure improving constitution in Traditional Chinese Medicine?
Secondary ID [1] 281653 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obstructive sleep apnea syndrome 287941 0
Condition category
Condition code
Respiratory 288319 288319 0 0
Sleep apnoea
Alternative and Complementary Medicine 288320 288320 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
nasal continuous positive airway pressure (nCPAP), participant will wear it during sleeping at least 4 hours per night and lasted for twelve weeks. Initial pressure of CPAP is set between 4-20 cm H2O, and will be adjusted in a 4-week interval according to participant's response.
Intervention code [1] 286189 0
Treatment: Devices
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288492 0
Traditional Chinese Medicine (TCM) constitution, as assessed by Constitution in Chinese Medicine Questionnaire (CCMQ), and answered by participants
Timepoint [1] 288492 0
At baseline, 4 and 12 weeks after treatment
Secondary outcome [1] 300303 0
TCM examination (tongue, voice and pulse examination), as assessed by photograph, sound recorder and a pulse diagnostic device
Timepoint [1] 300303 0
At baseline, 4 and 12 weeks after treatment
Secondary outcome [2] 300304 0
neck and waist circumference, body weight and height
Timepoint [2] 300304 0
At baseline, 4 and 12 weeks after treatment
Secondary outcome [3] 300305 0
Quality of life, as assessed by the 36-Item short-form healthy survey (SF-36), and answered by patients.
Timepoint [3] 300305 0
At baseline, 4 and 12 weeks after treatment
Secondary outcome [4] 300306 0
status sleepiness, as assessed by the Epworth Sleepiness Scale (ESS), and answered by participants
Timepoint [4] 300306 0
At baseline, 4 and 12 weeks after treatment

Eligibility
Key inclusion criteria
patients with obstructive sleep apnea syndrome which is diagnosed by polysomngraphy
Minimum age
20 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. patients who refuse to receive treatment of CPAP
2. patients who have some situation that CPAP is not the first choice and other treatment is suggested (eg. surgical intervention for tonsil enlargement).
3. patients who has 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 of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/04/2011
Actual
18/04/2011
Date of last participant enrolment
Anticipated
30/04/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 4742 0
Taiwan, Province Of China
State/province [1] 4742 0

Funding & Sponsors
Funding source category [1] 286451 0
Government body
Name [1] 286451 0
Department of Industrial Technology (DoIT) of the Ministry of Economic Affairs
Country [1] 286451 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] 285239 0
None
Name [1] 285239 0
Address [1] 285239 0
Country [1] 285239 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288530 0
Chang Gung Medical Foundation Institutional Review Board
Ethics committee address [1] 288530 0
No.123, Dinghu Rd., Guishan Township, Taoyuan County 333, Taiwan, R.O.C.
Ethics committee country [1] 288530 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 288530 0
Approval date [1] 288530 0
11/04/2011
Ethics approval number [1] 288530 0
100-0798B

Summary
Brief summary
Obstructive sleep apnea syndrome (OSAS) is composed of sleeping apnea and hypopnea. It also accompanied with fatigue, daytime sleepiness and poor concentration and memory in such patients. The standard treatment for it is usage of continuous positive airway pressure during sleeping. In this study, we want to know condition of Traditional Chinese Medicine (TCM) constitution in patients with OSAS, and to see if treatment of CPAP improves patients' TCM constitution.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36538 0
Dr Yen-Lung, Chen
Address 36538 0
No.123, Dinghu Rd., Guishan Township, Taoyuan County 333, Taiwan, R.O.C.
Country 36538 0
Taiwan, Province Of China
Phone 36538 0
+886-3-3196200
Fax 36538 0
Email 36538 0
[email protected]
Contact person for public queries
Name 36539 0
Yen-Lung, Chen
Address 36539 0
No.123, Dinghu Rd., Guishan Township, Taoyuan County 333, Taiwan, R.O.C.
Country 36539 0
Taiwan, Province Of China
Phone 36539 0
+886-3-3196200
Fax 36539 0
Email 36539 0
[email protected]
Contact person for scientific queries
Name 36540 0
Yen-Lung, Chen
Address 36540 0
No.123, Dinghu Rd., Guishan Township, Taoyuan County 333, Taiwan, R.O.C.
Country 36540 0
Taiwan, Province Of China
Phone 36540 0
+886-3-3196200
Fax 36540 0
Email 36540 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.