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:
NCT01826032
Eligibility Criteria:
Inclusion Criteria:
1. Men and women ≥ 65 years old.
2. Patients diagnosed with OSA with an apnea-hypopnea index per hour \>30.
3. Patients with an Epworth Sleep Scale score ≤ 12 (without excessive daytime sleepiness).
4. Signed written informed consent.
Exclusion Criteria:
1. Patients with severe chronic diseases: cardiovascular or pulmonary, neurological (stroke, epilepsy, head injury...) or psychiatric.
2. Any current significant systemic illness or unstable medical condition that could lead to difficulty in complying with the protocol or may, in the opinion of the investigator, compromise the conclusions.
3. Mini Mental State Exam (MMSE) \<24.
4. Any MRI exclusions - presence of aneurysm clips, pacemakers, mechanic heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body.
5. Previous CPAP treatment.
6. Psycho-physical inability to complete questionnaires. Inadequate visual and auditory acuity will be excluded.
7. Presence of any previously diagnosed sleep disorders: narcolepsy, insomnia, chronic sleep deprivation, REM behavior disorder and restless leg syndrome.
8. Patients with \> 50% of central apneas or the presence of Cheyne-Stokes Respiration.
9. History of alcohol abuse or dependence.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT01826032
Study Brief:
Protocol Section:
NCT01826032