Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001311842
Ethics application status
Approved
Date submitted
13/12/2012
Date registered
19/12/2012
Date last updated
30/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of brain perfusion by Tc-99m ECD SPECT/CT, plasma biomarker and cognition function in sleep obstructive apnea patients before and after treatment
Scientific title
Evaluation of brain perfusion by Tc-99m ECD SPECT/CT, plasma biomarker and cognition function in sleep obstructive apnea patients before and after CPAP or surgery treatment.
Secondary ID [1] 281679 0
Nil Known
Universal Trial Number (UTN)
U1111-1137-9060
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obstructive sleep apnea syndrome (OSA)
primary snore 287963 0
Condition category
Condition code
Respiratory 288350 288350 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two interventions (CPAP and surgery).
CPAP: Brad of ResMed-- S8 autoset Spirit in automatic positive airway pressure model. The participants put on the facial mask when sleeping, open the power of machine and the machine will start to work and automatically give the postitive pressure. Duration: 4 to 8 hours a day for 3 months
Surgery: Uvulopalatopharyngoplasty, occur once. Approximate duration of uvulopalatopharyngoplasty: 1 hour
All participants undergo only one intervention. Either CPAP or surgery treatment will be chosen by each participant.
Intervention code [1] 286212 0
Treatment: Surgery
Intervention code [2] 286213 0
Treatment: Devices
Comparator / control treatment
The control group means we plan to recruite subjects who have snore but no obstructive sleep apnea during sleep. We would like to know the differences between thes two groups, snore without obstructive sleep apnea and snore with obstructive sleep apnea. There is no control group for treatment.
Control group
Active

Outcomes
Primary outcome [1] 288513 0
Tc-99m ECD brain perfusion SPECT/CT
Timepoint [1] 288513 0
3 months later after CPAP/surgery treatment
Primary outcome [2] 288535 0
plasma biomarkers
Timepoint [2] 288535 0
3 months later after CPAP/surgery treatment
Primary outcome [3] 288536 0
computerized cognition function test
Timepoint [3] 288536 0
3 months later after CPAP/surgery treatment
Secondary outcome [1] 300374 0
SF 36 for measuring quality of life
Timepoint [1] 300374 0
3 months later after CPAP/surgery treatment
Secondary outcome [2] 300418 0
Epworth Sleepiness Scale for evaluating the average daytime sleepiness
Timepoint [2] 300418 0
3 months later after CPAP/surgery treatment

Eligibility
Key inclusion criteria
moderate and severe degree obstructive sleep apnea patients
age: 20~60 years old
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with symptoms of present of other sleep disorder, history of receiving medical intervention for sleep-related breathing disorder, cognition deterioration, hypertension, cancer, use of psychoactive medication, history of head injury with conscious loss and structural brain abnormalities

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation is not concealed
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Either CPAP or surgery treatment is depending on the choice of each participant.
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
described statistical analysis, T-test, image data analysis (SPM), regession model

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/01/2013
Actual
13/05/2013
Date of last participant enrolment
Anticipated
31/12/2015
Actual
30/09/2015
Date of last data collection
Anticipated
Actual
30/12/2015
Sample size
Target
70
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 4753 0
Taiwan, Province Of China
State/province [1] 4753 0

Funding & Sponsors
Funding source category [1] 286469 0
Hospital
Name [1] 286469 0
Show Chwan Memorial Hospital
Country [1] 286469 0
Taiwan, Province Of China
Primary sponsor type
Hospital
Name
Show Chwan Memorial Hospital
Address
No. 542,Sec 1 Chung-shan Rd., Changhua 500, Taiwan.
Country
Taiwan, Province Of China
Secondary sponsor category [1] 285258 0
None
Name [1] 285258 0
Address [1] 285258 0
Country [1] 285258 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288545 0
Show Chwan Memorial Hospital
Ethics committee address [1] 288545 0
No. 542,Sec 1 Chung-shan Rd., Changhua 500, Taiwan
Ethics committee country [1] 288545 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 288545 0
06/04/2012
Approval date [1] 288545 0
07/06/2012
Ethics approval number [1] 288545 0
1010406

Summary
Brief summary
The aim of the study is to evaluate brain perfusion on Tc-99m ECD SPECT/CT, cognition function test and questionnaires in OSA patients before and after treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36630 0
Dr Chun-Yi Lin
Address 36630 0
No. 542,Sec 1 Chung-shan Rd., Changhua 500, Taiwan
Country 36630 0
Taiwan, Province Of China
Phone 36630 0
886-4-7256166
Fax 36630 0
886-4-7115633
Email 36630 0
[email protected]
Contact person for public queries
Name 36631 0
Chun-Yi Lin
Address 36631 0
No. 542,Sec 1 Chung-shan Rd., Changhua 500, Taiwan
Country 36631 0
Taiwan, Province Of China
Phone 36631 0
886-4-7256166
Fax 36631 0
886-4-7115633
Email 36631 0
[email protected]
Contact person for scientific queries
Name 36632 0
Chun-Yi Lin
Address 36632 0
No. 542,Sec 1 Chung-shan Rd., Changhua 500, Taiwan
Country 36632 0
Taiwan, Province Of China
Phone 36632 0
886-4-7256166
Fax 36632 0
886-4-7115633
Email 36632 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.