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Trial registered on ANZCTR


Registration number
ACTRN12615001130550
Ethics application status
Approved
Date submitted
22/07/2015
Date registered
26/10/2015
Date last updated
30/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the effects of Continuous Positive Airway Pressure (CPAP) or upper airway modification surgery in Obstructive Sleep Apnoea (OSA)
Scientific title
Effects of CPAP or upper airway modification surgery on regional cerebral blood flow, neurocognitive function, biomarkers and circadian genes in OSA
Secondary ID [1] 287132 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive sleep apnea 295678 0
Condition category
Condition code
Respiratory 295950 295950 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two interventions (CPAP and upper airway surgery).
CPAP: Brand of ResMed-- S8 autoset Spirit in automatic positive airway pressure model. The participants put on the facial mask when sleeping, turn on the machine and the machine will start to work and automatically give the positive pressure. Diary will be used to moniter adherence of the CPAP. The dose setting of the CPAP: 10 cm H2O. Duration: 4 to 8 hours a day for 3 months
Surgery: Uvulopalatopharyngoplasty with or without tongue base reduction, occur once. Uvulopalatopharyngoplasty means to remove and/or remodel of tissues in the throat to reduce airway obstruction. Sleep surgeon perform the surgery. The operating surgeon will decide whether the patient receives a tongue base reduction or not based on size of tongue. 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] 292390 0
Treatment: Surgery
Intervention code [2] 292391 0
Treatment: Devices
Comparator / control treatment
It is a pre-post comparison study. CPAP is considered to be the comparator group.
Control group
Active

Outcomes
Primary outcome [1] 295635 0
cerebral blood flow on Tc-99m ECD SPECT/CT
Timepoint [1] 295635 0
3 months after commencement of CPAP treatment or surgery treatment
Primary outcome [2] 295636 0
Neurocognitive function using Neurobehavioral Evaluation System 2 (NES 2)
Timepoint [2] 295636 0
3 months after commencement of CPAP or surgery treatment
Secondary outcome [1] 316048 0
hsCRP, IL-6, IL-8, TNF-a:biomarkers of inflammation, assessed by blood sample
Timepoint [1] 316048 0
3 months after commencement of CPAP or surgery treatment
Secondary outcome [2] 316058 0
adiponectine:biomarker of adipocytokine, assessed by blood sample
Timepoint [2] 316058 0
3 months after commencement of CPAP or surgery treatment
Secondary outcome [3] 317045 0
leptin:biomarker of energy balance, assessed by blood sample
Timepoint [3] 317045 0
3 months after commencement of CPAP or surgery treatment
Secondary outcome [4] 317046 0
serotonin:biomarker of neurotransmitter, assessed by blood sample
Timepoint [4] 317046 0
3 months after commencement of CPAP or surgery treatment
Secondary outcome [5] 317047 0
brain-derived neurotrophic factor (BDNF): biomarker of canonical nerve growth factor, assessed by blood sample
Timepoint [5] 317047 0
3 months after commencement of CPAP or surgery treatment
Secondary outcome [6] 317048 0
mRNA circadian genes expression by real-time quantitative polymerase chain reaction (Q-PCR) analysis
sample used for assessment: blood
Timepoint [6] 317048 0
3 months after commencement of CPAP or surgery treatment

Eligibility
Key inclusion criteria
Adults diagnosed as obstructive sleep apnea syndrome (OSAS), apnea-hypopnea index (AHI) of 5 or greater
Minimum age
20 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those with symptoms of present of other sleep disorders, stroke, history of receiving medical intervention for sleep-related breathing disorder, cognition deterioration, cancer,
use of psychoactive medication, history of head injury with conscious loss and structural brain abnormalities will be excluded.

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)
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
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
1. Sample size calculation:
Lin et al. reported that the leptin levels before and after successful surgical treatment in OSAS patients were 24.2 +/- 6.1 ng/ml and 15.9 +/- 6.0 ng/ml. Based on the mean values and standard deviation of the previous study, P value 0.05 and power 0.8 were set, the sample size was estimated as 18 using two sample comparison means. According to the results of sample size calculation and accounting for dropout rates 10%, we plan to recruit 20 participants in this study.
2. Described statistical analysis, T-test, image data analysis (SPM), regression model

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/09/2015
Date of last participant enrolment
Anticipated
31/07/2016
Actual
15/06/2016
Date of last data collection
Anticipated
15/09/2016
Actual
15/09/2016
Sample size
Target
20
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 7044 0
Taiwan, Province Of China
State/province [1] 7044 0

Funding & Sponsors
Funding source category [1] 291691 0
Government body
Name [1] 291691 0
Ministry of Science and Technology
Country [1] 291691 0
Taiwan, Province Of China
Primary sponsor type
Government body
Name
Ministry of Science and Technology
Address
106, Sec. 2, Heping E. Rd., Taipei 10622, Taiwan, R.O.C.
Country
Taiwan, Province Of China
Secondary sponsor category [1] 290366 0
Hospital
Name [1] 290366 0
Show Chwan Memorial Hospital
Address [1] 290366 0
No. 542,Sec 1 Chung-shan Rd., Changhua 500, Taiwan.
Country [1] 290366 0
Taiwan, Province Of China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293218 0
Show Chwan Memorial Hospital
Ethics committee address [1] 293218 0
No. 542,Sec 1 Chung-shan Rd., Changhua 500, Taiwan
Ethics committee country [1] 293218 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 293218 0
Approval date [1] 293218 0
04/06/2015
Ethics approval number [1] 293218 0
1040405

Summary
Brief summary
The aim of the study is to evaluate the effects of CPAP or upper airway surgery for OSA on regional cerebral blood flow, neurocognitive function, biomarkers, circadian genes in obstructive sleep apnea syndrome.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58946 0
Dr Chun-Yi Lin
Address 58946 0
Show Chwan Memorial Hospital
No. 542,Sec 1 Chung-shan Rd., Changhua 500, Taiwan
Country 58946 0
Taiwan, Province Of China
Phone 58946 0
+886-4-7256166
Fax 58946 0
+886-4-7115633
Email 58946 0
[email protected]
Contact person for public queries
Name 58947 0
Chun-Yi Lin
Address 58947 0
Show Chwan Memorial Hospital
No. 542,Sec 1 Chung-shan Rd., Changhua 500, Taiwan
Country 58947 0
Taiwan, Province Of China
Phone 58947 0
+886-4-7256166
Fax 58947 0
+886-4-7115633
Email 58947 0
[email protected]
Contact person for scientific queries
Name 58948 0
Chun-Yi Lin
Address 58948 0
Show Chwan Memorial Hospital
No. 542,Sec 1 Chung-shan Rd., Changhua 500, Taiwan
Country 58948 0
Taiwan, Province Of China
Phone 58948 0
+886-4-7256166
Fax 58948 0
+886-4-7115633
Email 58948 0
[email protected]

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