Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-24 @ 10:01 PM
NCT ID:
NCT06377332
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT06377332
Study Brief:
Protocol Section:
NCT06377332