Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06377332
Status:
RECRUITING
Last Update Posted:
2024-04-22
First Post:
2023-11-06
Brief Title:
Biomarkers of Dementia in Chronic Sleep and Breathing Disorders
Sponsor:
Woolcock Institute of Medical Research
Organization:
Woolcock Institute of Medical Research
Study Overview
Official Title:
Biomarkers of Dementia in Chronic Sleep and Breathing Disorders
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ORACLE
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
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
Detailed Description:
Neurodegeneration that is present in dementia is caused in part by neuroinflammation cerebral vascular damage and oxidative stress Intermittent hypoxia and hypercapnia as seen in patients with chronic obstructive pulmonary disease COPD obstructive sleep apnoea OSA and overlap syndrome cause neuroinflammation and sleep fragmentation As a result key biomarkers of cytokine tumour necrosis factor-alpha TNF-a C-reactive protein CRP eosinophils CD8 and CD4 T cells interleukin-6 IL-6 interleukin-8 IL-8 interleukin-1 beta IL-1B nuclear factor kappa beta NF-kB and hypoxia-inducible factor HIF infiltrate the central nervous system CNS perpetuating neuroinflammation through the presence of microglia which cause oxidative and nitrosative stress
Key inflammatory and dementia-based biomarkers will be collected in the investigation of this association including but not limited to Aβ4042 ratio and ptau217
This study consists of an observational cross-sectional design with the utilisation of blood collection lung function testing MRI HdEEG fNIRS and neurocognitive assessment Participants will be selected into the study differentially based on the target group with OSA criteria requiring an ODI 15 COPD criteria requiring a GOLD 2 minimum FEV1 50 80 predicted FEV1FVC 07 with a 10- pack year smoking history and overlap syndrome criteria requiring a combination of ODI 15 and GOLD 2 minimum FEV1 50 80 predicted FEV1FVC 07 with a 10-pack year smoking history Participants will be 40 to 65 years old Controls will have no diagnosis of OSA COPD or overlap syndrome and have an English fluency In order to test the hypotheses the design of a cross-sectional study will allow us to a examine the relationships between sleep and breathing metrics and cognition and blood-based markers of dementia pathology b examine the relationships between potential intermediates of compromised sleep and breathing with the primary cognitive and dementia risk outcomes c compare sleep lung function brain health cognition and inflammatory markers between OSA COPD overlap syndrome and control groups
Key inflammatory and dementia-based biomarkers will be collected in the investigation of this association including but not limited to Aβ4042 ratio and ptau217
This study consists of an observational cross-sectional design with the utilisation of blood collection lung function testing MRI HdEEG fNIRS and neurocognitive assessment Participants will be selected into the study differentially based on the target group with OSA criteria requiring an ODI 15 COPD criteria requiring a GOLD 2 minimum FEV1 50 80 predicted FEV1FVC 07 with a 10- pack year smoking history and overlap syndrome criteria requiring a combination of ODI 15 and GOLD 2 minimum FEV1 50 80 predicted FEV1FVC 07 with a 10-pack year smoking history Participants will be 40 to 65 years old Controls will have no diagnosis of OSA COPD or overlap syndrome and have an English fluency In order to test the hypotheses the design of a cross-sectional study will allow us to a examine the relationships between sleep and breathing metrics and cognition and blood-based markers of dementia pathology b examine the relationships between potential intermediates of compromised sleep and breathing with the primary cognitive and dementia risk outcomes c compare sleep lung function brain health cognition and inflammatory markers between OSA COPD overlap syndrome and control groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None