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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

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]

NHMRC 632597

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Sleep Apnea

Carotid Artery Atherosclerosis

Condition category

Condition code

Respiratory

Sleep apnoea

Cardiovascular

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]

Treatment: Devices

Intervention code [2]

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]

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]

3 months 6 months 9 months and 12 months

Secondary outcome [1]

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]

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?

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

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment postcode(s) [1]

2120

Recruitment postcode(s) [2]

2121

Recruitment postcode(s) [3]

2123

Recruitment postcode(s) [4]

2124

Recruitment postcode(s) [5]

2125

Recruitment postcode(s) [6]

2126

Recruitment postcode(s) [7]

2127

Recruitment postcode(s) [8]

2128

Recruitment postcode(s) [9]

2129

Recruitment postcode(s) [10]

2130

Recruitment postcode(s) [11]

2131

Recruitment postcode(s) [12]

2132

Recruitment postcode(s) [13]

2133

Recruitment postcode(s) [14]

2134

Recruitment postcode(s) [15]

2135

Recruitment postcode(s) [16]

2136

Recruitment postcode(s) [17]

2137

Recruitment postcode(s) [18]

2138

Recruitment postcode(s) [19]

2140

Recruitment postcode(s) [20]

2141

Recruitment postcode(s) [21]

2142

Recruitment postcode(s) [22]

2143

Recruitment postcode(s) [23]

2144

Recruitment postcode(s) [24]

2145

Recruitment postcode(s) [25]

2146

Recruitment postcode(s) [26]

2147

Recruitment postcode(s) [27]

2148

Recruitment postcode(s) [28]

2150

Recruitment postcode(s) [29]

2151

Recruitment postcode(s) [30]

2153

Recruitment postcode(s) [31]

2154

Recruitment postcode(s) [32]

2155

Recruitment postcode(s) [33]

2156

Recruitment postcode(s) [34]

2157

Recruitment postcode(s) [35]

2158

Recruitment postcode(s) [36]

2159

Recruitment postcode(s) [37]

2160

Recruitment postcode(s) [38]

2161

Recruitment postcode(s) [39]

2162

Recruitment postcode(s) [40]

2163

Recruitment postcode(s) [41]

2164

Recruitment postcode(s) [42]

2165

Recruitment postcode(s) [43]

2166

Recruitment postcode(s) [44]

2167

Recruitment postcode(s) [45]

2168

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC

Address [1]

Level 1
16 Marcus Clarke St
CANBERRA ACT 2601

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney West Area Health Service Human Research Ethics Committee

Ethics committee address [1]

Sydney West Area Health Service Human Research Ethics Committee
PO Box 533
WENTWORTHVILLE  NSW  2145

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

25/09/2007

Ethics approval number [1]

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

Prof John Wheatley

Address

Westmead Hospital PO Box 533 WENTWORTHVILLE NSW 2145

Country

Australia

Phone

+61288906797

Fax

[email protected]

Contact person for public queries

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

Phone

+61288906797

Fax

+61288907286

[email protected]

Contact person for scientific queries

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

Phone

+61288906797

Fax

+61288907286

[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

Source	Title	Year of Publication	DOI
Embase	Predictors for carotid and femoral artery intima-media thickness in a non-diabetic sleep clinic cohort.	2021	https://dx.doi.org/10.1371/journal.pone.0252569

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically