protocolSection identificationModule nctId: NCT06377332, orgStudyIdInfo id: X23-0330, briefTitle: Biomarkers of Dementia in Chronic Sleep and Breathing Disorders, acronym: ORACLE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2025-07-01, completionDateStruct date: 2025-07-01, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Woolcock Institute of Medical Research, class: OTHER, descriptionModule briefSummary: Chronic obstructive pulmonary disease (COPD), obstructive sleep apnoea (OSA) and overlap syndrome are associated with obstructions in breathing and disturbed sleep.Chronic breathing disruptions and poor sleep may lead to cognitive impairment and brain changes linked with early neurodegenerative processes. As such, identifying early markers of cognitive impairment and dementia risk in individuals with chronic respiratory and sleep breathing disorders is crucial for understanding how these diseases may contribute to accelerated brain ageing. This study will comprehensively measure sleep, lung function, cognitive performance and blood-based markers of dementia risk and inflammation. The investigators will use innovative technologies to identify biomarkers of cognitive impairment and dementia risk in people with chronic sleep and breathing disorders. The investigators will also investigate the relationships between disrupted sleep and abnormal breathing and the brain. This research may also inform future early interventions to improve cognition and brain health in chronic sleep and respiratory disease., conditionsModule conditions: COPD, conditions: Overlap Syndrome, conditions: OSA, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 104, type: ESTIMATED, armsInterventionsModule interventions name: High density electroencephalogram (HdEEG), interventions name: Functional near infrared spectroscopy (fNIRS), interventions name: Magnetic resonance imaging (MRI), interventions name: Blood collection, interventions name: Neuropsychological battery, interventions name: Questionnaires, interventions name: Pulmonary Function Test (PFT), interventions name: Cognitive Assessment, interventions name: Polysomnogram (PSG), outcomesModule primaryOutcomes measure: Scores on the Montreal Cognitive Assessment (MoCA) neuropsychological assessment for dementia risk., primaryOutcomes measure: Blood levels of amyloid beta (Aβ40/Aβ42 ratio)., secondaryOutcomes measure: Absolute Electroencephalographic (EEG) Power During Non-Rapid Eye Movement (NREM) Sleep., secondaryOutcomes measure: Brain tissue oxygenation during cognitive tasks and sleep., secondaryOutcomes measure: Hypoxemia as measured by pulse oximetry., secondaryOutcomes measure: Sleep Fragmentation, secondaryOutcomes measure: Assessment of premorbid functioning and preinjury through the Test of Premorbid Functioning (TOPF)., secondaryOutcomes measure: Assessment of verbal learning and memory through the Rey Auditory Verbal Learning Test (RAVLT)., secondaryOutcomes measure: Assessment of mild forms of cognitive dysfunction through Delis Kaplan Executive Functioning System (D-CEFS) neuropsychological assessment., secondaryOutcomes measure: Assessment of speed of processing and executive functioning through the Trail Making Test (TMT)., secondaryOutcomes measure: Assessment of verbal fluency through the Controlled Oral Word Association Test (COWAT)., secondaryOutcomes measure: Assessment of attention, perceptual speed, motor speed and visual scanning through the Symbol Digits Modalities Test (SDMT)., secondaryOutcomes measure: Blood levels of fibrinogen., secondaryOutcomes measure: Blood levels of clusterin., secondaryOutcomes measure: Blood levels of 8-isoprostane, secondaryOutcomes measure: Blood levels of C-reactive protein (CRP), secondaryOutcomes measure: Blood levels of erythrocyte sedimentation rate (ESR)., secondaryOutcomes measure: Blood levels of plasma tau., secondaryOutcomes measure: Blood levels of neurofilament light chain (NFL)., secondaryOutcomes measure: Blood levels of Glial fibrillary acidic protein (GFAP)., secondaryOutcomes measure: Blood levels of Apolipoprotein E gene (APOE-4)., secondaryOutcomes measure: Blood levels of interleukin-8 (IL-8)., secondaryOutcomes measure: Blood levels of interleukin-6 (IL-6)., secondaryOutcomes measure: Blood levels of tumor necrosis factor alpha (TNFα)., secondaryOutcomes measure: Blood levels of amyloid beta (Aβ40/Aβ42 ratio)., secondaryOutcomes measure: Scores on the Montreal Cognitive Assessment (MoCA) neuropsychological assessment for dementia risk., otherOutcomes measure: Brain structure: cortical thickness and volumetric brain maps, otherOutcomes measure: Brain structure: diffusion-weighted imaging, otherOutcomes measure: Brain function: resting-state BOLD fMRI, otherOutcomes measure: Brain pathology: T1-weighted, T2-weighted, diffusion-weighted imaging, and FLAIR, otherOutcomes measure: Assessment of sensorimotor function and comprehension through the Motor Screening Task (MOT) of CANTAB., otherOutcomes measure: Assessment of processing and psychomotor speed through the Reaction Time (RTI) test of CANTAB., otherOutcomes measure: Assessment of working memory and strategy through the Spatial Working Memory (SWM) test of CANTAB., otherOutcomes measure: Assessment of visual episodic memory through the Paired Associate Learning (PAL) test of CANTAB., otherOutcomes measure: Sleep Spindles During Non-Rapid Eye Movement (NREM) Sleep, otherOutcomes measure: Traditional sleep staging., otherOutcomes measure: Absolute Electroencephalography (EEG) Power During Rapid Eye Movement (REM) Sleep., otherOutcomes measure: Obstructive sleep apnoea (OSA) severity metrics, otherOutcomes measure: Lung function as measured by clinical pulmonary function tests (PFT), eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Woolcock Institute of Medical Research, status: RECRUITING, city: Sydney, state: New South Wales, zip: 2113, country: Australia, contacts name: Angela D'Rozario, PhD, role: CONTACT, phone: 02 9850 3246, email: angela.drozario@mq.edu.au, contacts name: Laura Harris, MScMed, role: CONTACT, phone: 02 9805 3194, email: laura.harris@woolcock.org.au, geoPoint lat: -33.86785, lon: 151.20732, hasResults: False