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Search / Trial NCT06377332

Biomarkers of Dementia in Chronic Sleep and Breathing Disorders

Launched by WOOLCOCK INSTITUTE OF MEDICAL RESEARCH · Apr 16, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Biomarkers Observational Cross Sectional

ClinConnect Summary

This clinical trial is studying how chronic breathing problems like chronic obstructive pulmonary disease (COPD), obstructive sleep apnea (OSA), and their combination (known as overlap syndrome) can affect brain health. Researchers want to find early signs that might indicate a risk of cognitive decline or dementia in people with these conditions. To do this, they will measure aspects like sleep patterns, lung function, and cognitive abilities, as well as look at blood markers related to dementia and inflammation. The goal is to understand how these breathing disorders could lead to faster brain aging and to potentially develop early treatments to help improve brain health.

To participate in the study, you need to be between 40 and 65 years old, speak English, and be able to give consent and complete cognitive tests. Depending on your condition, you will either be part of a control group, have OSA, COPD, or overlap syndrome. Unfortunately, if you have been diagnosed with dementia, certain other serious health issues, or have recently been treated for breathing problems, you may not be eligible. If you join, you can expect to undergo various assessments related to your sleep, breathing, and thinking abilities, which can help researchers learn more about the connections between these health issues and brain function.

Gender

ALL

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.

About Woolcock Institute Of Medical Research

The Woolcock Institute of Medical Research is a leading Australian research organization dedicated to advancing the understanding and treatment of respiratory and sleep disorders. Established in Sydney, the Institute combines innovative clinical research with a strong emphasis on translational medicine, aiming to improve patient outcomes through evidence-based practices. With a multidisciplinary team of researchers, clinicians, and scientists, the Woolcock Institute actively collaborates with national and international partners to drive groundbreaking studies and clinical trials, contributing significantly to the global body of knowledge in pulmonary health and sleep medicine.

Locations

Sydney, New South Wales, Australia

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported