NCT05742360 Effect of CPAP on Blood Pressure in Excessively Sleepy Obstructive Sleep Apnea Subtype
| NCT ID | NCT05742360 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ohio State University |
| Condition | Obstructive Sleep Apnea |
| Study Type | OBSERVATIONAL |
| Enrollment | 227 participants |
| Start Date | 2023-02-07 |
| Primary Completion | 2027-03-01 |
Trial Parameters
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Brief Summary
The primary objective of this study is to determine the longer-term (6 months) effect of CPAP therapy on change in 24-hour mean blood pressure (24hMBP) in OSA subjects with the excessively sleepy symptom subtype.
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