ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618000618257

Ethics application status

Approved

Date submitted

13/04/2018

Date registered

20/04/2018

Date last updated

6/05/2021

Date data sharing statement initially provided

6/05/2021

Type of registration

Retrospectively registered

Titles & IDs

Public title

Amyloid deposition and cognitive function in Obstructive Sleep Apnoea

Scientific title

.Amyloid deposition and cognitive function in Obstructive Sleep Apnoea

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

ADiOSA

Linked study record

Health condition

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

Obstructive Sleep Apnoea

Condition category

Condition code

Respiratory

Sleep apnoea

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

The study group is individuals with moderate to severe obstructive sleep apnoea.

Participants attend 1 x 2.5-hour face-to-face cognitive testing session that is run by a Research Assistant with experience in administering the testing materials . Participants are asked to complete a number of self-report questionnaires and cognitive/mood assessment tasks. Participants undergo 1x 18-F-NAV4694 PET scan to observe the amount of amyloid in the brain. An introvenous line will be inserted into a vein of the arm for the injection of the imaging agent. Participants will rest for 50 minutes and then be positioned lying down with their head in the PET scanner. A 20-minute image will be acquired starting at 50 minutes post injection of the 18F-NAV4694.

Intervention code [1]

Early Detection / Screening

Comparator / control treatment

Health individuals with no sleep disorder, age and gender matched.

Control group

Active

Outcomes

Primary outcome [1]

Degree of brain beta-amyloid burden as assessed by Positron Emission Tomography imaging.

Timepoint [1]

Baseline

Secondary outcome [1]

Level of daytime sleepiness assessed using the Epworth Sleepiness Scale (ESS)

Timepoint [1]

Baseline

Secondary outcome [2]

Cognitive function and mood measured using Mini Mental State Examination

Timepoint [2]

Baseline

Secondary outcome [3]

Severity of Obstructive Sleep Apnoea (OSA) assessed by Apnoea Hypopnea Index (AHI) result from Sleep Study

Timepoint [3]

Screening

Secondary outcome [4]

Cognitive function and mood measured using Delis-Kaplan Executive Function System

Timepoint [4]

Baseline

Secondary outcome [5]

Cognitive function and mood measured using Wechsler Test of Adult Reading

Timepoint [5]

Baseline

Secondary outcome [6]

Cognitive function and mood measured using WAIS Digit Span

Timepoint [6]

Baseline

Secondary outcome [7]

Cognitive function and mood measured using Digit Symbol Coding

Timepoint [7]

Baseline

Secondary outcome [8]

Cognitive function and mood measured using Wechsler Memory Scale - Fourth Edition (WMS-IV) Logical Memory Task

Timepoint [8]

Baseline

Secondary outcome [9]

Cognitive function and mood measured using Autobiographical Memory Test

Timepoint [9]

Baseline

Secondary outcome [10]

Cognitive function and mood measured using Rey Complex Figure Test

Timepoint [10]

Baseline

Secondary outcome [11]

Cognitive function and mood measured using Cogstate Battery

Timepoint [11]

Baseline

Secondary outcome [12]

Cognitive function and mood measured using Hospital Anxiety and Depression Scale

Timepoint [12]

Baseline

Secondary outcome [13]

Cognitive function and mood measured using Subtle Cognitive Impairment Test

Timepoint [13]

Baseline

Secondary outcome [14]

Cognitive function and mood measured using Trail Making Test

Timepoint [14]

Baseline

Secondary outcome [15]

Cognitive function and mood measured using Samn-Perelli Fatigue Scale

Timepoint [15]

Baseline

Secondary outcome [16]

Cognitive function and mood measured using Geriatric Depression Scale

Timepoint [16]

Baseline

Secondary outcome [17]

Cognitive function and mood measured using Autobiographical Memory Interview

Timepoint [17]

Baseline

Eligibility

Key inclusion criteria

Aged 50-75 years; OSA diagnosis (AHI>15 events/hr); are OSA treatment-naïve; sufficient English to undertake cognitive testing; able to provide informed consent.

Healthy controls will be age- and gender-matched to the OSA group. The will be required to have sufficient English to undertake cognitive testing; able to provide informed consent; must have no sleep disorder (AHI <5 events/hr).

Minimum age

50 Years

Maximum age

75 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Active medical or psychiatric condition that may interfere with study procedures; or a previous diagnosis of dementia; pregnancy.

Study design

Purpose

Screening

Duration

Cross-sectional

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

Statistical analysis will be in the form of independent samples t-tests comparing overall amyloid burden and cognitive function between of the OSA patients and healthy controls. Regression analyses will be conducted to between clinical outcomes (cognition, sleepiness, sleep variables, demographics) and amyloid burden.

Recruitment

Recruitment status

Stopped early

Data analysis

Data analysis is complete

Reason for early stopping/withdrawal

Lack of funding/staff/facilities

Date of first participant enrolment

Anticipated

Actual

8/12/2016

Date of last participant enrolment

Anticipated

1/04/2019

Actual

12/12/2019

Date of last data collection

Anticipated

28/06/2019

Actual

18/12/2019

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Austin Health - Austin Hospital - Heidelberg

Recruitment postcode(s) [1]

3084 - Heidelberg

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Institute for Breathing and Sleep

Address [1]

Bowen Centre, Austin Health
145 Studley Road
Heidelberg, Victoria, 3084

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Brain Foundation

Address [2]

PO Box 579
Crows Nest NSW 1585

Country [2]

Australia

Funding source category [3]

Charities/Societies/Foundations

Name [3]

Equity Trustee

Address [3]

Level 1, 575 Bourke St
Melbourne
Vic 3000

Country [3]

Australia

Primary sponsor type

Charities/Societies/Foundations

Name

Institute for Breathing and Sleep

Address

Bowen Centre, Austin Hospital
145 Studley Road
Heidelberg, Victoria, 3084

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health Human Research Ethics Committee

Ethics committee address [1]

Austin Hospital
145 Studley Rd,
Heidelberg VIC 3084
PO Box 5555 Heidelberg

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

01/07/2016

Ethics approval number [1]

Summary

Brief summary

Obstructive Sleep Apnoea (OSA) is a highly prevalent chronic illness, characterised by repetitive collapse of the airway during sleep, causing falls in blood oxygen levels and sleep disruption. OSA is associated with cognitive deficits, especially memory impairments. Another common condition, dementia, is in the top 4 causes of burden of disease of high-income nations. It affects over 340,000 Australians. OSA is common in patients with dementia, with estimates of 38-45% of dementia patients having OSA. The risk of Alzheimer’s disease and vascular dementia has been shown to increase in patients with OSA. However, a direct causal link between these two conditions has not been established. 
Beta-amyloid deposits are commonly found in the brains of patients with dementia, and are implicated in the development of dementia. Positron emission tomography (PET) can be used to assess levels of amyloid in the brains of patients, and these levels can be associated with cognitive function.  Previous studies performed at Austin Health have found significant associations between amyloid levels and memory impairment in patients with mild cognitive impairment. To date, no studies have examined whether OSA is associated with higher levels of beta amyloid deposits or Alzheimer’s disease -type neural changes, or how these changes relate to cognitive performance. 
This study will use PET scanning techniques to examine the levels of amyloid in the brains of patients with OSA, and compare these to brain scans of healthy participants. This study will also conduct cognitive assessments in the OSA patients and healthy controls, examining associations between cognitive performance and amyloid levels.
Identifying potential biomarkers of amyloid burden in OSA could have important implications for early detection and risk assessment. Early identification of the risk of developing dementia in patients with OSA is important as it allows the possibility of a simple intervention that targets the sleep disorder that may be contributing towards the development of neural and cognitive impairment, before it progresses to dementia.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Melinda Jackson

Address

Turner Institute for Brain and Mental Health
Sleep and Circadian Rhythms
School of Psychological Sciences
Monash University
18 Innovation Walk, Clayton, VIC, 3800

Country

Australia

Phone

+61399050206

Fax

melinda.jackson@monash.edu

Contact person for public queries

Name

Marina Cavuoto

Address

Institute for Breathing and Sleep, Austin Health
Level 5, Harold Stokes Building, Austin Hospital
PO Box 5555, Heidelberg, Victoria, 3084

Country

Australia

Phone

+613 9496 3517

Fax

marina.cavuoto@austin.org.au

Contact person for scientific queries

Name

Melinda Jackson

Address

Turner Institute for Brain and Mental Health
Sleep and Circadian Rhythms
School of Psychological Sciences
Monash University
18 Innovation Walk, Clayton, VIC, 3800

Country

Australia

Phone

+61399050206

Fax

melinda.jackson@monash.edu

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

n/a

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.

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