ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12612000891820

Ethics application status

Approved

Date submitted

2/08/2012

Date registered

22/08/2012

Date last updated

22/12/2017

Type of registration

Retrospectively registered

Titles & IDs

Public title

Study to determine whether low-dose aspirin in healthy older adults prevents cognitive decline in those identified as having moderate to severe sleep apnoea: the SNORE-ASA substudy of the Aspirin in Reducing Events in the Elderly (ASPREE) study.

Scientific title

Study of Neurocognitive Outcomes, Radiological and retinal effects of Aspirin in Sleep Apnoea to determine the effects of daily low-dose aspirin 100mg versus placebo on cognitive outcomes in the setting of sleep apnoea, in healthy older adults aged 70 and over.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1133-2126

Trial acronym

SNORE-ASA

Linked study record

Health condition

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

Cognitive decline

Sleep Apnoea

Condition category

Condition code

Neurological

Dementias

Respiratory

Sleep apnoea

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This study is a sub study of the Aspirin in Reducing Events in the Elderly study (ASPREE, ClinicalTrials.gov identifier NCT01038583, website www.aspree.org). ASPREE is a double blinded, randomised controlled trial of low dose daily aspirin, 100mg oral tablets versus placebo, taken daily for five years in healthy participants aged 70 and over, followed over 5 years for the primary outcomes of dementia-free survival and disability-free survival. It is a primary prevention study.

The SNORE-ASA study will involve a subset of newly enrolling participants in the parent ASPREE study.

Prior to randomisation into the parent ASPREE study, SNORE-ASA participants take home a small, light and portable home sleep apnoea screening device named ApneaLink Plus. This device has a nasal cannula to measure airflow, a finger clip pulse oximeter, and can calculate the Apnoea Hypnoea Index (AHI) and Oxygen Desaturation Index (ODI), both of which are measures of the presence and severity of sleep apnoea. Participants are required to wear this for one night only, at study entry only.

While participants in the ASPREE study are randomised to oral aspirin 100mg or placebo taken once a day for five years, the SNORE-study outcome measures will be performed after 3 years. However, unblinding of whether the SNORE-ASA participants were randomised to either placebo or aspirin will not take place until after the 5 years of the parent ASPREE study.

A further subset of participants in the SNORE-ASA study will undergo a brain MRI and have retinal vascular imaging (also called retinal photography) at baseline and after 3 years to investigate the mechanism by which sleep apnoea may potentiate cognitive decline, and how aspirin may be protective against this.

Intervention code [1]

Treatment: Drugs

Intervention code [2]

Prevention

Intervention code [3]

Early detection / Screening

Comparator / control treatment

placebo - identical in appearance to aspirin, with the same enteric coating.

Control group

Placebo

Outcomes

Primary outcome [1]

Cognitive decline as measured by change in the modified mini mental state examination (3MS)

Timepoint [1]

3 years

Secondary outcome [1]

Change in brain MRI measures of white matter hyperintensity including volume

Timepoint [1]

3 years

Secondary outcome [2]

Change in Retinal Vascular Imaging (RVI) parameters

Timepoint [2]

3 years

Secondary outcome [3]

Cognitive decline as defined by a fall in summed average z-scores of >1 SD on any cognitive domain evaluated

Timepoint [3]

3 years

Eligibility

Key inclusion criteria

Enrolling into the parent ASPREE study.
Aged 70 and over
Able and willing to provide informed consent

Minimum age

70 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

History of a diagnosed cardiovascular event, including AMI and stroke, atrial fibrillation, serious intercurrent illness likely to cause death within 5 years, cognitive impairment or dementia, disability, anaemia, a current or recurrent condition with a high risk of major bleeding, absolute contraindication or allergy to aspirin.

Also known history of sleep apnoea and/ or current use of continuous positive airways pressure (CPAP) at night

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Enrollment into the parent study ASPREE is through general practitioner co-investigators. Informed consent for participation in ASPREE is obtained by ASPREE research staff. Enrollment into the SNORE-ASA study takes place at the second baseline ASPREE visit, prior to randomisation to either aspirin or placebo in ASPREE.

Randomisation takes place through the parent ASPREE study. All staff remain blinded to treatment allocation through the randomisation procedure.

The randomisation list is generated by an independent statistician using the STATA "ralloc" procedure with randomisation stratified for site and age (<80 yrs and >80 yrs).

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The randomisation list is generated by an independent statistician using the STATA "ralloc" procedure with randomisation stratified for site and age (<80 yrs and >80 yrs).

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Phase 4

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

27/03/2012

Actual

27/03/2012

Date of last participant enrolment

Anticipated

Actual

6/01/2015

Date of last data collection

Anticipated

29/12/2017

Actual

Sample size

Target

1500

Accrual to date

Final

1400

Recruitment in Australia

Recruitment state(s)

ACT,NSW,SA,VIC

Recruitment postcode(s) [1]

3004

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC

Address [1]

Level 1
16 Marcus Clarke Street
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

Monash University

Address

ASPREE National Co-ordinating Centre
Department of Epidemiology and Preventive Medicine
Ground Floor, Burnet Building
89 Commercial Rd
Melbourne VIC 3004

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Alfred Health Human Ethics Committee

Ethics committee address [1]

Ethics & Research Governance
Ground Floor, Linay Pavilion
The Alfred Hospital
Commercial Road, Melbourne, 3004
Victoria

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

21/11/2011

Approval date [1]

30/01/2012

Ethics approval number [1]

1/11/0452

Ethics committee name [2]

Monash University Human Research Ethics Committee

Ethics committee address [2]

First Floor, Building 3e
Monash Research Office
Clayton Campus
Monash University VIC 3800
Victoria

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

01/02/2012

Approval date [2]

13/02/2012

Ethics approval number [2]

CF12/0367

Ethics committee name [3]

ACT Health Human Research Ethics Committee

Ethics committee address [3]

The Canberra Hospital Building 10 level 6
Yamba Drive Garran ACT 2605

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

05/11/2012

Approval date [3]

30/11/2012

Ethics approval number [3]

10.12.245

Ethics committee name [4]

University of Adelaide Human Research Ethics Committee

Ethics committee address [4]

The University of Adelaide
South Australia 5005

Ethics committee country [4]

Australia

Date submitted for ethics approval [4]

01/11/2012

Approval date [4]

13/12/2012

Ethics approval number [4]

H-2012-162

Summary

Brief summary

Sleep Disordered Breathing (SDB) is very common in older adults. Previous studies have identified that approximately 50% of adults aged 70 and over have some degree of SDB. Obstructive Sleep Apnoea (OSA) is the most common form and refers to intermittent obstructions to airflow during sleep, most often associated with snoring.

While OSA has been shown to be associated with cognitive dysfunction in middle aged adults, the effect of OSA on cognitive outcomes in older adults is less well established, as there have been few prospective studies. 
 
SNORE-ASA will investigate whether sleep apnoea in healthy older adults is associated with cognitive decline over three years of follow-up, and whether daily low dose aspirin is protective against this cognitive decline associated with sleep apnoea. The study will also examine how sleep apnoea may cause cognitive decline in older adults, by using brain MRI and retinal photography to determine whether sleep apnoea causes hypoxaemia-induced small blood vessel flow problems (ischaemia), and whether aspirin alters this process.

Trial website

http://www.aspree.org/AUS/aspree-content/aspree-sub-studies/SNOREASA.aspx

Trial related presentations / publications

 Hamilton GS, O'Donoghue FJ. The brain in obstructive sleep apnea: the chickens
coming home to roost? Sleep. 2013 May 1;36(5):637-9. doi: 10.5665/sleep.2616.
PubMed PMID: 23633745; PubMed Central PMCID: PMC3624817.

Conference Oral Presentation, Australia and New Zealand Society of Geriatric Medicine Annual Scientific Meeting June 1-3, 2016 Cairns, Australia.
SA Ward, GS Hamilton, R Woods, MT Naughton, F O’Donoghue, D O’Reilly, JJ McNeil, E Storey. Diagnosing Sleep Disordered Breathing in community dwelling older people: lessons from the SNORE-ASA clinical trial Australasian Journal on Ageing, Vol 35 Supplement S1, June 2016, 18–41

Ward SA, Storey E, Woods RL, Hamilton GS, Kawasaki R, Janke AL, Naughton MT,
O'Donoghue F, Wolfe R, Wong TY, Reid CM, Abhayaratna WP, Stocks N, Trevaks R,
Fitzgerald S, Hodgson LAB, Robman L, Workman B, McNeil JJ; ASPREE Study Group.
The Study of Neurocognitive Outcomes, Radiological and Retinal Effects of Aspirin
in Sleep Apnoea- rationale and methodology of the SNORE-ASA study. Contemp Clin
Trials. 2017 Oct 31. pii: S1551-7144(17)30444-5. doi: 10.1016/j.cct.2017.10.016. 
[Epub ahead of print] PubMed PMID: 29097299.

Public notes

Contacts

Principal investigator

Name

Prof Elsdon Storey

Address

Department of Neuroscience
Alfred Hospital
Commercial Road
Melbourne, VIC
3004
Australia

Country

Australia

Phone

+61 3 90762552

Fax

elsdon.storey@monash.edu

Contact person for public queries

Name

Dr Stephanie Ward

Address

ASPREE National Coordinating Centre
Ground Floor, Burnet Building
89 Commercial Rd
Melbourne 3004
Victoria

Country

Australia

Phone

1800 728 745

Fax

+61 03 9903 0979

stephanie.ward@monash.edu

Contact person for scientific queries

Name

Dr Stephanie Ward

Address

ASPREE National Coordinating Centre
Ground Floor, Burnet Building
89 Commercial Rd
Melbourne 3004
Victoria

Country

Australia

Phone

1800 728 745

Fax

+61 03 9903 0979

stephanie.ward@monash.edu

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

Source	Title	Year of Publication	DOI
Embase	Age-related macular degeneration in a randomized controlled trial of low-dose aspirin: Rationale and study design of the ASPREE-AMD study.	2017	https://dx.doi.org/10.1016/j.conctc.2017.03.005

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

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