Identifying dementia biomarkers in patients with chronic sleep and breathing disorders

Biomarkers of Dementia in Chronic Sleep and Breathing Disorders

This study is trying to see if problems with sleep and breathing in people with COPD and sleep apnea can lead to early signs of dementia.

Quick facts

• Study type: Observational
• Enrollment: 104 (estimated)
• Ages: 40 Years to 65 Years
• Sex: All
• Sponsor: Woolcock Institute of Medical Research (Academic / other)
• Locations: 1 site (Sydney, New South Wales)
• Trial ID: NCT06377332 on ClinicalTrials.gov

What this trial studies

This observational study aims to explore the relationship between chronic obstructive pulmonary disease (COPD), obstructive sleep apnoea (OSA), and overlap syndrome with cognitive impairment and dementia risk. It will utilize innovative technologies to measure sleep patterns, lung function, cognitive performance, and blood-based biomarkers associated with dementia. Participants will undergo various assessments, including MRI, high-density EEG, and neuropsychological testing, to identify potential early markers of cognitive decline. The study focuses on understanding how disrupted sleep and abnormal breathing may contribute to neuroinflammation and brain changes linked to dementia.

Who should consider this trial

Good fit: Ideal candidates are males and females aged 40-65 with confirmed moderate to severe OSA, COPD, or overlap syndrome.

Not a fit: Patients outside the age range of 40-65 or those without chronic sleep and breathing disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to early identification of dementia risk in patients with chronic respiratory and sleep disorders, allowing for timely interventions.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in identifying biomarkers related to cognitive impairment in chronic respiratory conditions.

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.

Where this trial is running

Sydney, New South Wales

• The Woolcock Institute of Medical Research — Sydney, New South Wales, Australia (Recruiting)

Study contacts

• Study coordinator: Angela D'Rozario

Conditions COPD; Overlap Syndrome; OSA; Biomarkers; Observational; Cross-Sectional