NCT06377332 · UNKNOWN
Biomarkers of Dementia in Chronic Sleep and Breathing Disorders
This observational study is testing whether people with chronic breathing and sleep disorders — COPD, sleep apnea, or both — show early blood and brain markers linked to dementia risk. Researchers will use brain scans, sleep studies, blood tests, and cognitive assessments to look for those signals. There is no drug or treatment being given. Because no phase is listed, this is a research observation study, not a clinical drug trial.
Eligibility criteria
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. 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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2024-04-22