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:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-25 @ 4:33 AM
NCT ID:
NCT04609618
Eligibility Criteria:
Inclusion Criteria:
1. OSA diagnosed; AHIā„20
2. Male and Female Aged 40 to 70 years old
3. Patients of childbearing potential must agree to use methods of contraception and have negative pregnancy test at screening. Effective methods of contraception must be used throughout the study
4. BMI\< 35
5. Patient is willing and able to give his/her written informed consent
Exclusion Criteria:
1. Chronic lung disease (including Asthma and COPD)
2. Congestive Heart Failure
3. Exhibiting any flu-like or upper respiratory illness symptoms at time of assessment
4. History of severe nasal allergies or sinusitis or difficulty breathing through the nose
5. Persistent blockage of one or both nostrils
6. Any previous operation or trauma to the nose
7. Previous diagnosis of insomnia, narcolepsy, periodic limb movement disorder, respiratory failure
8. Any use of antipsychotic, Hypnotic drugs
9. Major neurological diagnosis
10. Active malignant disease including chemotherapy or radiotherapy treatment
11. Pregnant or lactating women
12. Drug abuse
13. Medical history of epilepsy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT04609618
Study Brief:
Protocol Section:
NCT04609618