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 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT06000332
Eligibility Criteria:
Inclusion Criteria:
1. Subjects may be of any gender
2. Subject's age must be 40 - 80 years
3. Subjects must have a current prescription for nocturnal oxygen \< 3 L/min continuous or current use of a Portable Oxygen Concentrator.
Exclusion Criteria:
1. Subject is using any ancillary medical device(s) that may interfere with the operation of or data interpretation from the InogenOne device (such as CPAP/BiPAP, NIV).
2. Subjects with nasal obstruction
3. Subjects taking any drugs that affect respiratory center drive
4. Subject has an acute illness or hospitalization within the last 30 days
5. Subject has a change in medication within the last 15 days
6. Subject is currently receiving respiratory stimulant medications (such as acetazolamide, medroxyprogesterone, doxapram, theophylline/aminophylline, protriptyline and buspirone)
7. Subject has significant comorbidities that in the opinion of the Investigator would interfere with outcomes and/or study conduct
8. Subject's prescribed treatment is in conflict with study procedures
9. Subjects with any unstable disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT06000332
Study Brief:
Protocol Section:
NCT06000332