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 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT06413134
Eligibility Criteria:
Inclusion Criteria:
1. AHI \> 10 on a previous PSG or HST (hypopneas requiring 4% desaturation).
2. Central apneas \< 25% of events
3. PLM (Periodic Limb Movements) arousal index \< 15
Exclusion Criteria:
1. A female of child-bearing potential that is pregnant or intends to become pregnant.
2. Any unstable or severe medical condition of any organ system including congestive heart failure, COPD, renal failure, neuromuscular disease, etc., or at the discretion of the site Principal Investigator (PI).
3. Taking medication that may affect sleep, sleepiness, or alertness including hypnotics, sedatives, alerting agents, stimulants, anticonvulsants, etc.
4. The presence of any other sleep disorder (insomnia, periodic limb movement disorder, etc).
5. Prior therapy or treatment for OSA.
6. Chronic oxygen therapy.
7. Excessive alcohol consumption (\>14 drinks/week).
8. The use of any illegal drug(s).
9. Any condition that in the investigator's opinion would present an unreasonable risk to the participant, or which would interfere with their participation in the study or confound study interpretation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT06413134
Study Brief:
Protocol Section:
NCT06413134