Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000250932
Ethics application status
Approved
Date submitted
7/03/2011
Date registered
8/03/2011
Date last updated
14/02/2020
Date data sharing statement initially provided
14/02/2020
Date results information initially provided
14/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
What is the impact of continuous positive airway pressure (CPAP)treatment on coronary artery disease in subjects with heavy snoring and mild sleep disordered breathing?
Scientific title
A prospective, randomised controlled trial of nasal continous positive airway pressure (CPAP) in heavy snorers with mild to moderate SDB looking for regression and/or stabilisation of carotid artery atherosclerosis.
Secondary ID [1] 259735 0
NHMRC 632597
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Apnea 261316 0
Carotid Artery Atherosclerosis 261317 0
Condition category
Condition code
Respiratory 259466 259466 0 0
Sleep apnoea
Cardiovascular 259467 259467 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects are intially subdivided into drug and non drug use with regards to maintenance of their lipid/blood sugar stability. This will allow us to more easily monitor any differences in these two groups should they occur. Patients are then randomised to treatment i.e. continuous positive airway pressure (CPAP) or non treatment (no CPAP). CPAP will be used during sleep where possible throughout the trial period (approximately 12 months) once randomised to tthe CPAP group. All subjects will be reviewed with a monthly health maintenance questionnaire for the 12 month duration of the trial. Ultrasound, lipid and fasting blood sugar testing will be carried out at screening, 3 , 6 , 9 and 12 months (trial conclusion). CPAP group will have hours of use monitored at monthly intervals throughout the trial following an intial acclimatisation period which will have several follow ups in a week, if required, to help the patient settle to the treatment. Monthly follow ups maybe phone/face to face excluding the 3, 6, 9 and 12 month visit which will be face to face.
Intervention code [1] 264166 0
Treatment: Devices
Intervention code [2] 264167 0
Early detection / Screening
Comparator / control treatment
Subjects randomised to the non treatment group will routinely be screened with a health maintenance questionaire including; maintenance of weight, blood pressure, general health, stable lipid and BSL. Routine questionnaire screening will be monthly for the 12 month duration of the trial. Test subjects will additionally use continuous positive airway therapy(CPAP) at all possible sleep times to prevent sleep disordered breathing and snoring for the duration of the trial. All subjects will undergo carotid ultrasound at screening, 3, 6, 9 and 12 months. Lipid and fasting blood sugar will also be taken/reviewed at the 3,6,9 and 12 month visits. CPAP subjects will have hours of use reviewed at monthly intervals following an intial acclimatisation period which would have several phone/face to face contacts (subject preference) in the week or longer (per subject negotiation).
Control group
Active

Outcomes
Primary outcome [1] 262282 0
Stabilisation or regression of early changes of carotid atherosclerosis by measurement of carotid IMT (intermedia thickness) per ultrasound in subjects using continuous positive airpressure therapy (CPAP)
Timepoint [1] 262282 0
3 months 6 months 9 months and 12 months
Secondary outcome [1] 273455 0
Stabilisation or regression of early changes of carotid atherosclerosis by measurement of plaque type and extent, carotid diameter and peak systolic velocity. per ultrasound in subjects using continuous positive airpressure therapy (CPAP)
Timepoint [1] 273455 0
3 months 6 months 9 months and 12 months

Eligibility
Key inclusion criteria
Snoring greater than 50% of total sleep time (TST)
Apnea hypopnea index (AHI) <30 events per hour and oxygen desaturation index of < 5 events per hour
Normal fasting bloods for lipid profile and blood sugar level
Non smoker or not smoked in the past year
Minimum age
46 Years
Maximum age
69 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of stroke
History of diabetes
History of clinically severe nasal or sinus disease
History of carotid artery surgery

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Radomisation carried out by contacting the holder of the allocation schedule (generated by a statistician) who will be at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Prospective enrolment from referrals for standard polysomnography from a University Hospital. Randomisation will be stratified according to mediciation use/non use for cardiovascular risk factors at baseline with randomisation in blocks of into each treatment arm i.e. continuous positive airway pressure (CPAP) plus monitoring of optimal standard therapy (questionnaire based) for maintenance of weight, blood pressure and lipid profile or optimal standard therapy alone (questionnaire based as for CPAP subjects)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/01/2011
Actual
5/09/2011
Date of last participant enrolment
Anticipated
Actual
15/12/2016
Date of last data collection
Anticipated
Actual
15/12/2017
Sample size
Target
130
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 3812 0
2120
Recruitment postcode(s) [2] 3813 0
2121
Recruitment postcode(s) [3] 3814 0
2123
Recruitment postcode(s) [4] 3815 0
2124
Recruitment postcode(s) [5] 3816 0
2125
Recruitment postcode(s) [6] 3817 0
2126
Recruitment postcode(s) [7] 3818 0
2127
Recruitment postcode(s) [8] 3819 0
2128
Recruitment postcode(s) [9] 3820 0
2129
Recruitment postcode(s) [10] 3821 0
2130
Recruitment postcode(s) [11] 3822 0
2131
Recruitment postcode(s) [12] 3823 0
2132
Recruitment postcode(s) [13] 3824 0
2133
Recruitment postcode(s) [14] 3825 0
2134
Recruitment postcode(s) [15] 3826 0
2135
Recruitment postcode(s) [16] 3827 0
2136
Recruitment postcode(s) [17] 3828 0
2137
Recruitment postcode(s) [18] 3829 0
2138
Recruitment postcode(s) [19] 3830 0
2140
Recruitment postcode(s) [20] 3831 0
2141
Recruitment postcode(s) [21] 3832 0
2142
Recruitment postcode(s) [22] 3833 0
2143
Recruitment postcode(s) [23] 3834 0
2144
Recruitment postcode(s) [24] 3835 0
2145
Recruitment postcode(s) [25] 3836 0
2146
Recruitment postcode(s) [26] 3837 0
2147
Recruitment postcode(s) [27] 3838 0
2148
Recruitment postcode(s) [28] 3839 0
2150
Recruitment postcode(s) [29] 3840 0
2151
Recruitment postcode(s) [30] 3841 0
2153
Recruitment postcode(s) [31] 3842 0
2154
Recruitment postcode(s) [32] 3843 0
2155
Recruitment postcode(s) [33] 3844 0
2156
Recruitment postcode(s) [34] 3845 0
2157
Recruitment postcode(s) [35] 3846 0
2158
Recruitment postcode(s) [36] 3847 0
2159
Recruitment postcode(s) [37] 3848 0
2160
Recruitment postcode(s) [38] 3849 0
2161
Recruitment postcode(s) [39] 3850 0
2162
Recruitment postcode(s) [40] 3851 0
2163
Recruitment postcode(s) [41] 3852 0
2164
Recruitment postcode(s) [42] 3853 0
2165
Recruitment postcode(s) [43] 3854 0
2166
Recruitment postcode(s) [44] 3855 0
2167
Recruitment postcode(s) [45] 3856 0
2168

Funding & Sponsors
Funding source category [1] 264616 0
Government body
Name [1] 264616 0
NHMRC
Country [1] 264616 0
Australia
Primary sponsor type
Individual
Name
Professor John Wheatley
Address
Professor John Wheatley
Director Department of Respiratory and Sleep Medicine
Westmead Hospital
PO Box 533
WENTWORTHVILLE NSW 2145
Country
Australia
Secondary sponsor category [1] 263754 0
None
Name [1] 263754 0
Address [1] 263754 0
Country [1] 263754 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260617 0
Sydney West Area Health Service Human Research Ethics Committee
Ethics committee address [1] 260617 0
Sydney West Area Health Service Human Research Ethics Committee
PO Box 533
WENTWORTHVILLE NSW 2145
Ethics committee country [1] 260617 0
Australia
Date submitted for ethics approval [1] 260617 0
Approval date [1] 260617 0
25/09/2007
Ethics approval number [1] 260617 0
HREC2007/8/4.7(2646)

Summary
Brief summary
Snoring and mild sleep disordered breathing (SDB) are a common consequence of increased upper airway resistance during sleep. Habitual snoring (every night or almost every night) without overt obstructive sleep apnoea hypopnoea syndrome (OSAHS) is common in the community. Increasingly it is recognized that snoring and mild SDB are not just an annoying social problem but may pose real risks to health. Emerging research is highly suggestive of an independent role in the occurence of hypertension, stroke, coronary and carotid atherosclosis. The aim of this study is to further explore the linkage between heavy snoring with mild SDB and early carotid artery atherosclerosis by looking for regression or stabilisation of early changes of carotid atherosclerosis in heavy snorers with mild non-hypoxic SDB when snoring and SDB are prevented by the use of nasal continuous positive airway pressure (CPAP).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32312 0
Prof John Wheatley
Address 32312 0
Westmead Hospital PO Box 533 WENTWORTHVILLE NSW 2145
Country 32312 0
Australia
Phone 32312 0
+61288906797
Fax 32312 0
Email 32312 0
[email protected]
Contact person for public queries
Name 15559 0
Prof Professor John Wheatley
Address 15559 0
Professor John Wheatley
Director Department of Respiratory and Sleep Medicine
Westmead Hospital
PO Box 533
WENTWORTHVILLE NSW 2145
Country 15559 0
Australia
Phone 15559 0
+61288906797
Fax 15559 0
+61288907286
Email 15559 0
[email protected]
Contact person for scientific queries
Name 6487 0
Prof Professor John Wheatley
Address 6487 0
Professor John Wheatley
Director Department of Respiratory and Sleep Medicine
Westmead Hospital
PO Box 533
WENTWORTHVILLE NSW 2145
Country 6487 0
Australia
Phone 6487 0
+61288906797
Fax 6487 0
+61288907286
Email 6487 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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
SourceTitleYear of PublicationDOI
EmbasePredictors for carotid and femoral artery intima-media thickness in a non-diabetic sleep clinic cohort.2021https://dx.doi.org/10.1371/journal.pone.0252569
N.B. These documents automatically identified may not have been verified by the study sponsor.