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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06377332
Registration number
NCT06377332
Ethics application status
Date submitted
6/11/2023
Date registered
22/04/2024
Titles & IDs
Public title
Biomarkers of Dementia in Chronic Sleep and Breathing Disorders
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Scientific title
Biomarkers of Dementia in Chronic Sleep and Breathing Disorders
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Secondary ID [1]
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X23-0330
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Universal Trial Number (UTN)
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Trial acronym
ORACLE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
COPD
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Overlap Syndrome
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OSA
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Condition category
Condition code
Neurological
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Dementias
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Neurological
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Alzheimer's disease
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Diagnosis / Prognosis - High density electroencephalogram (HdEEG)
Diagnosis / Prognosis - Functional near infrared spectroscopy (fNIRS)
Diagnosis / Prognosis - Magnetic resonance imaging (MRI)
Treatment: Other - Blood collection
Diagnosis / Prognosis - Neuropsychological battery
Other interventions - Questionnaires
Diagnosis / Prognosis - Pulmonary Function Test (PFT)
Other interventions - Cognitive Assessment
Diagnosis / Prognosis - Polysomnogram (PSG)
Chronic Obstructive Pulmonary Disease (COPD) - Males and females; Aged 40-65 years; COPD confirmed by diagnosis or a positive lung function test (GOLD 2 minimum, FEV1
=50%, \< 80% predicted; FEV1/FVC \< 0.7); 10-pack year smoking history; Able to perform neuropsychological and cognitive testing; Fluent in English.
Overlap Syndrome (OVS) - Males and females; Aged 40-65 years; Oximetry confirmed moderate to severe OSA based on the oxygen desaturation index (ODI) =15/hr OR defined by polysomnography (PSG) AHI of = 15 COPD confirmed by diagnosis or a positive lung function test (GOLD 2 minimum, FEV1
=50%, \< 80% predicted; FEV1/FVC \< 0.7); 10-pack year smoking history; Able to perform neuropsychological and cognitive testing; Fluent in English.
Obstructive Sleep Apnoea (OSA) - Males and females; Aged 40-65 years; Oximetry confirmed moderate to severe OSA based on the oxygen desaturation index (ODI) =15/hr OR defined by polysomnography (PSG) AHI of = 15. Able to give informed consent; Ability to perform neuropsychological and cognitive testing; Fluent in English.
Control - Males and females; Aged 40-65 years; Able to give informed consent; Able to perform neuropsychological and cognitive testing; Fluent in English.
Diagnosis / Prognosis: High density electroencephalogram (HdEEG)
High-density electroencephalography (HdEEG) will be utilised in the investigation of sleep-mediated neuronal functions in controls, OSA, COPD and overlap syndrome and the association with accelerated brain ageing and cognitive impairment.
Diagnosis / Prognosis: Functional near infrared spectroscopy (fNIRS)
Functional near infrared spectroscopy (fNIRS) is one of the most advanced techniques in measuring brain oxygen content and hemodynamic activity. This information indirectly displays neuronal activity and provides a novel opportunity understand brain oxygenation, neurodegenerative diseases, and cognitive function.
Diagnosis / Prognosis: Magnetic resonance imaging (MRI)
Magnetic resonance imaging (MRI) will be utilised to assess potential structural neuronal changes associated with neurodegenerative disease in those with COPD, OSA and overlap syndrome. MRI has the capacity to provide vital information regarding neuroimaging standards in cerebral vascular damage such as white matter hyperintensities (WMH), lacunes, cerebral microbleeds, brain atrophy and subcortical infarct. Through the utility of MRI sequences such as T1 and T2 weighted imaging, diffusion weighted imaging (DWI) and fluid-attenuated inversion recovery (FLAIR) and resting-state fMRI (rs-fMRI), the investigators will assess neurodegenerative-related structural brain changes in individuals with COPD, OSA and overlap syndrome and examine the differences between these target groups.
Treatment: Other: Blood collection
A fasting 50mL blood sample will be collected at the experimental visit in the morning following the overnight sleep study. Blood samples will be processed after collection and stored at -80 degrees for future batch analyses. Analyses will include markers for inflammation and dementia including but not limited to ptau217 and beta amyloid. Routine blood analyses will be conducted on 17.5mL of the sample collected for baseline measures. Routine blood analyses includes lipid profile, glucose studies, insulin, high-sensitivity C-reactive protein (hs-CRP), iron studies, thyroid function, b12/folate, homocysteine, prolactin, calcium, full blood count and biochemistry panel for the OSA, COPD and overlap syndrome groups.
Routine blood analyses for controls include glucose studies, lipid profile, hs-CRP and biochemistry panel.
Diagnosis / Prognosis: Neuropsychological battery
A. Montreal Cognitive Assessment (MoCA):
B. Test of Premorbid Functioning (TOPF):
C. Rey Auditory Verbal Learning Test (RAVLT):
D. D-KEFS Colour Word Interference Test (D-CWIT):
E. Trail Making Test (TMT):
F. Symbol Digit Modalities Test (SDMT) - Oral Version:
G. RAVLT 20-minute recall
H. Controlled Oral Word Association Test (COWAT):
Other interventions: Questionnaires
1. Epworth Sleepiness Scale (ESS)
2. PROMIS sleep questionnaire 8a,
3. PROMIS sleep questionnaire 8b
4. EQ-5D-5L
5. Insomnia Severity Index (ISI)
6. Pittsburgh Sleep Quality Index (PSQ-I)
7. St George's Respiratory Questionnaire (SGRQ)
8. COPD Assessment Test (CAT)
Diagnosis / Prognosis: Pulmonary Function Test (PFT)
Full pulmonary function testing will be conducted in control, COPD, OSA and overlap syndrome groups. Full lung function testing will include spirometry with pre and post bronchodilator, oscillometry, lung diffusion testing (DLCO) and lung volumes.
Other interventions: Cognitive Assessment
The following cognitive assessments will be administered using a digital format on CANTAB:
1. Motor Screening Task (MOT) Used to assess sensorimotor function and comprehension and is applicable in the assessment of general cognitive function, Alzheimer's disease and cerebrovascular disease. This task acts as a practice trial for the subsequent tasks.
2. Reaction Time (RTI) Used to assess processing and psychomotor speed and is applicable in the assessment of general cognitive function and Alzheimer's disease.
3. Paired Associate Learning (PAL) Used to assess visual episodic memory and is applicable in the assessment of general cognitive function, Alzheimer's disease, Parkinson's disease and cerebrovascular disease.
4. Spatial Working Memory (SWM) Used to assess working memory and strategy and is applicable in the assessment of general cognitive function, Alzheimer's disease and cerebrovascular disease.
Diagnosis / Prognosis: Polysomnogram (PSG)
During the sleep study, physiological signals are recorded to capture eye movements (electrooculogram, EOG) and chin muscle movements (electromyogram, EMG). A nasal airflow piece, two respiratory inductance plethysmography (RIP) bands and an oximeter probe on the finger will monitor breathing and oxygen levels in the blood. Electrocardiogram (ECG), leg movements, sleeping position and snoring are also recorded.
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Intervention code [1]
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Diagnosis / Prognosis
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Intervention code [2]
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Treatment: Other
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Intervention code [3]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Scores on the Montreal Cognitive Assessment (MoCA) neuropsychological assessment for dementia risk.
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Assessment method [1]
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MoCA scores of 18 to 25 indicate mild cognitive impairment, 10 to 17 indicate moderate cognitive impairment and scores below 10 indicate severe cognitive impairment.
Associations between MoCA and night-time hypoxemia / sleep fragmentation in the entire sample.
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Timepoint [1]
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Cross-sectional/baseline only
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Primary outcome [2]
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Blood levels of amyloid beta (Aß40/Aß42 ratio).
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Assessment method [2]
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Associations between blood levels of Aß (Aß40/Aß42 ratio) and night-time hypoxemia / sleep fragmentation in the entire sample.
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Timepoint [2]
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Cross-sectional/baseline only
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Secondary outcome [1]
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Absolute Electroencephalographic (EEG) Power During Non-Rapid Eye Movement (NREM) Sleep.
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Assessment method [1]
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Spectral power of delta (1-4.5 Hz), theta (4.5-8 Hz), alpha (8-12 Hz), sigma (12-15 Hz), beta (15-25 Hz), and gamma (25-40 Hz) frequency ranges. Associations between absolute Electroencephalographic (EEG) Power During Non-Rapid Eye Movement (NREM) Sleep and night-time hypoxemia / sleep fragmentation in the entire sample and between groups.
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Timepoint [1]
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Cross-sectional/baseline only
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Secondary outcome [2]
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Brain tissue oxygenation during cognitive tasks and sleep.
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Assessment method [2]
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Brain tissue oxygenation during sleep as measured by oxygenated and deoxygenated hemoglobin using functional Near Infrared Spectroscopy (fNIRS). Associations between brain tissue oxygenation and night-time hypoxemia / sleep fragmentation in the entire sample and between groups.
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Timepoint [2]
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Cross-sectional/baseline only
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Secondary outcome [3]
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Hypoxemia as measured by pulse oximetry.
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Assessment method [3]
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Overnight hypoxemia measured by pulse oximetry through nocturnal readings of blood oxygen saturation (SpO2). Associations between night-time hypoxemia / sleep fragmentation in the entire sample and between groups.
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Timepoint [3]
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Cross-sectional/baseline only
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Secondary outcome [4]
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Sleep Fragmentation
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Assessment method [4]
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EEG arousal index (events per minute of total sleep time) measured during polysomnography. Associations between night-time hypoxemia / sleep fragmentation in the entire sample and between groups.
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Timepoint [4]
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Cross-sectional/baseline only
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Secondary outcome [5]
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Assessment of premorbid functioning and preinjury through the Test of Premorbid Functioning (TOPF).
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Assessment method [5]
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Neuropsychological Test: A z-score of -0.75 indicates low-average premorbid functioning, z= -1.40 indicates borderline poor premorbid functioning and inferior premorbid functioning spans from z=-2.05 to -3.65. Associations between TOPF scores and night-time hypoxemia / sleep fragmentation in the entire sample and between groups.
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Timepoint [5]
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Cross-sectional/baseline only
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Secondary outcome [6]
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Assessment of verbal learning and memory through the Rey Auditory Verbal Learning Test (RAVLT).
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Assessment method [6]
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Neuropsychological Test: RAVLT scores between groups. Scores = z= -1.0 across two domains indicate poor performance. Immediate verbal learning is assessed by summing trials 1 to 5, Learning is assessed from trial 5 minus trial 1, and Forgetting is assessed through trial five minus the delayed recall trial. Associations between RAVLT scores and night-time hypoxemia / sleep fragmentation in the entire sample and between groups.
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Timepoint [6]
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Cross-sectional/baseline only
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Secondary outcome [7]
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Assessment of mild forms of cognitive dysfunction through Delis Kaplan Executive Functioning System (D-CEFS) neuropsychological assessment.
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Assessment method [7]
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Neuropsychological Test: Differences in scores between groups across the four trials. Greater time taken to complete the trials results in higher scores which indicate worse performance. Associations between D-CEFS scores night-time hypoxemia / sleep fragmentation in the entire sample and between groups.
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Timepoint [7]
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Cross-sectional/baseline only
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Secondary outcome [8]
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Assessment of speed of processing and executive functioning through the Trail Making Test (TMT).
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Assessment method [8]
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Neuropsychological Test: Differences in TMT scores between groups. Greater time taken to complete the tests results in higher scores which indicate worse performance. A TMT trial A score of =78 seconds and a TMT trial B score of =273 seconds indicates deficiency. Associations between TMT scores night-time hypoxemia / sleep fragmentation in the entire sample and between groups.
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Timepoint [8]
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Cross-sectional/baseline only
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Secondary outcome [9]
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Assessment of verbal fluency through the Controlled Oral Word Association Test (COWAT).
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Assessment method [9]
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Neuropsychological Test: Differences in the COWAT scores between groups. The more acceptable words stated across all four trials, the better the performance in the test. Associations between COWAT scores and night-time hypoxemia / sleep fragmentation in the entire sample and between groups.
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Timepoint [9]
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Cross-sectional/baseline only
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Secondary outcome [10]
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Assessment of attention, perceptual speed, motor speed and visual scanning through the Symbol Digits Modalities Test (SDMT).
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Assessment method [10]
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Neuropsychological Test: Differences in the scores on the SDMT between groups. Scores on the SDMT range from 1 to 110, with higher scores indicating better performance over the 90-second trial. Associations between SDMT scores and night-time hypoxemia / sleep fragmentation in the entire sample and between groups.
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Timepoint [10]
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Cross-sectional/baseline only
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Secondary outcome [11]
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Blood levels of fibrinogen.
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Assessment method [11]
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Differences in the blood levels of fibrinogen between groups. Associations between fibrinogen and night-time hypoxemia / sleep fragmentation in the entire sample and between groups.
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Timepoint [11]
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Cross-sectional/baseline only
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Secondary outcome [12]
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Blood levels of clusterin.
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Assessment method [12]
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Differences in the blood levels of clusterin between groups. Associations between clusterin and night-time hypoxemia / sleep fragmentation in the entire sample and between groups.
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Timepoint [12]
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Cross-sectional/baseline only
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Secondary outcome [13]
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Blood levels of 8-isoprostane
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Assessment method [13]
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Differences in the blood levels of 8-isoprostane between groups. Associations between 8-isoprostane and night-time hypoxemia / sleep fragmentation in the entire sample and between groups.
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Timepoint [13]
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Cross-sectional/baseline only
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Secondary outcome [14]
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Blood levels of C-reactive protein (CRP)
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Assessment method [14]
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Differences in the blood levels of CRP between groups. Associations between CRP and night-time hypoxemia / sleep fragmentation in the entire sample and between groups.
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Timepoint [14]
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Cross-sectional/baseline only
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Secondary outcome [15]
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Blood levels of erythrocyte sedimentation rate (ESR).
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Assessment method [15]
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Differences in the blood levels of ESR between groups. Associations between ESR and night-time hypoxemia / sleep fragmentation in the entire sample and between groups.
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Timepoint [15]
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Cross-sectional/baseline only
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Secondary outcome [16]
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Blood levels of plasma tau.
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Assessment method [16]
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Differences in the blood levels of plasma tau between groups. Associations between plasma-tau and night-time hypoxemia / sleep fragmentation in the entire sample and between groups.
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Timepoint [16]
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Cross-sectional/baseline only
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Secondary outcome [17]
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Blood levels of neurofilament light chain (NFL).
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Assessment method [17]
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Differences in the blood levels of NFL between groups. Associations between NFL and night-time hypoxemia / sleep fragmentation in the entire sample and between groups.
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Timepoint [17]
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Cross-sectional/baseline only
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Secondary outcome [18]
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Blood levels of Glial fibrillary acidic protein (GFAP).
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Assessment method [18]
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Differences in the blood levels of GFAP between groups. Associations between GFAP and night-time hypoxemia / sleep fragmentation in the entire sample and between groups.
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Timepoint [18]
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Cross-sectional/baseline only
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Secondary outcome [19]
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Blood levels of Apolipoprotein E gene (APOE-4).
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Assessment method [19]
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Differences in the blood levels of APOE-4 between groups. Associations between APOE-4 and night-time hypoxemia / sleep fragmentation in the entire sample and between groups.
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Timepoint [19]
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Cross-sectional/baseline only
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Secondary outcome [20]
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Blood levels of interleukin-8 (IL-8).
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Assessment method [20]
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Differences in the blood levels of IL-8 between groups. Associations between IL-8 and night-time hypoxemia / sleep fragmentation in the entire sample and between groups.
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Timepoint [20]
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Cross-sectional/baseline only
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Secondary outcome [21]
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Blood levels of interleukin-6 (IL-6).
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Assessment method [21]
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Differences in the blood levels of IL-6 between groups. Associations between IL-6 and night-time hypoxemia / sleep fragmentation in the entire sample and between groups.
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Timepoint [21]
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Cross-sectional/baseline only
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Secondary outcome [22]
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Blood levels of tumor necrosis factor alpha (TNFa).
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Assessment method [22]
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Differences in the blood levels of TNFa between groups. Associations between TNFa and night-time hypoxemia / sleep fragmentation in the entire sample and between groups.
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Timepoint [22]
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Cross-sectional/baseline only
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Secondary outcome [23]
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Blood levels of amyloid beta (Aß40/Aß42 ratio).
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Assessment method [23]
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Associations between blood levels of Aß (Aß40/Aß42 ratio) and night-time hypoxemia / sleep fragmentation between groups.
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Timepoint [23]
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Cross-sectional/baseline only
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Secondary outcome [24]
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Scores on the Montreal Cognitive Assessment (MoCA) neuropsychological assessment for dementia risk.
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Assessment method [24]
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MoCA scores of 18 to 25 indicate mild cognitive impairment, 10 to 17 indicate moderate cognitive impairment and scores below 10 indicate severe cognitive impairment.
Associations between MoCA and night-time hypoxemia / sleep fragmentation between groups.
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Timepoint [24]
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Cross-sectional/baseline only
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Eligibility
Key inclusion criteria
Control:
1. Males and females;
2. Aged 40-65 years;
3. Able to give informed consent;
4. Able to perform neuropsychological and cognitive testing;
5. Fluent in English.
OSA:
1. Males and females;
2. Aged 40-65 years;
3. Oximetry confirmed moderate to severe OSA based on the oxygen desaturation index (ODI) =15/hr;
4. Able to give informed consent;
5. Ability to perform neuropsychological and cognitive testing;
6. Fluent in English.
COPD:
1. Males and females;
2. Aged 40-65 years;
3. COPD confirmed by diagnosis or a positive lung function test (GOLD 2 minimum, FEV1
=50%, < 80% predicted; FEV1/FVC < 0.7);
4. 10-pack year smoking history;
5. Able to perform neuropsychological and cognitive testing;
6. Fluent in English.
Overlap Syndrome:
1. Males and females;
2. Aged 40-65 years;
3. Oximetry confirmed moderate to severe OSA based on the oxygen desaturation index (ODI) =15/hr;
4. COPD confirmed by diagnosis or a positive lung function test (GOLD 2 minimum, FEV1
=50%, < 80% predicted; FEV1/FVC < 0.7);
5. 10-pack year smoking history;
6. Able to perform neuropsychological and cognitive testing;
7. Fluent in English.
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Minimum age
40
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1. Dementia diagnosis;
2. At home or overnight oxygen therapy;
3. Asthma diagnosis (identified with lung function bronchodilator);
4. Current antipsychotic use;
5. BMI > 40;
6. PAP use or OSA treatment in the last 2 months;
7. Recent COPD exacerbation with change in symptomology (hospitalisation and/or steroids and/or antibiotics) within 6 weeks;
8. Awake supine oxygen saturations of < 93%;
9. Sleep disorders including narcolepsy, idiopathic hypersomnia (IH), moderate-severe restless leg syndrome (RLS) or REM behaviour disorder (RBD);
10. Other major comorbidities (other lung diseases, neurodegenerative disease, brain injury, severe mental illness, PTSD);
11. Uncontrolled depression (impacting daily life, no use of medications or engagement with psychotherapy- dictated by physician);
12. Malignancies (basal cell carcinoma accepted);
13. Any contraindication for MRI.
14. New York Heart Association (NYHA) score of IV or hospitalisation from heart failure in the last 6 months.
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/07/2025
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Actual
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Sample size
Target
104
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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The Woolcock Institute of Medical Research - Sydney
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Recruitment postcode(s) [1]
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2113 - Sydney
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Funding & Sponsors
Primary sponsor type
Other
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Name
Woolcock Institute of Medical Research
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT06377332
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Angela D'Rozario
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Address
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Country
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Phone
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02 9850 3246
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Data pertaining to the OSA group will be shared with protocol number X22-0213 (Project: OSA-D; within The Woolcock Institute of Medical Research)
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When will data be available (start and end dates)?
Data will become available upon collection. Data will be available for a minimum of 15 years.
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Available to whom?
n=26 obstructive sleep apnoea (OSA) participants will meet all of the OSA inclusion criteria and none of the exclusion criteria.
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06377332