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 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT05742360
Eligibility Criteria:
Inclusion Criteria:
* Age 18-75 years
* Moderate-severe OSA (defined as ODI ≥10 events/hour) via Polysomnography (PSG) or Home Sleep Apnea Study (HSAT) done based on clinical grounds
* Excessively sleepy subtype determined by patient-reported symptoms
* Willing to accept CPAP therapy
* An elevated baseline office BP defined as ≥120 or ≥80 mmHg
* Planned PAP (CPAP or bi-level PAP) treatment by treating provider
Exclusion Criteria:
* Recent changes (within 3 months) to BP medications among those who are on these medications
* Unable to apply ABPM cuff
* Current use of CPAP or other OSA treatments
* Resting, awake SaO2 \<90% or use of home oxygen therapy
* New York Heart Association (NYHA) categories III-IV of heart failure
* Presence of Cheyne-Stokes Respiration (CSR) in sleep study identified by typical crescendo-decrescendo pattern of respiration with associated apneas and/or hypopneas in the absence of inspiratory flow limitation
* Predominantly central sleep apnea (AHI≥15 events/hour, with \>50% central events \[apnea or hypopnea\])
* Life expectancy \<2 years
* Pregnancy
* Clinical history of chronic kidney disease (Stage 5) requiring dialysis, or renal transplant
* Systolic BP \> 180 mmHg
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05742360
Study Brief:
Protocol Section:
NCT05742360