Effect of CPAP on Blood Pressure in Excessively Sleepy Obstructive Sleep Apnea Subtype

Launched by OHIO STATE UNIVERSITY · Feb 20, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how Continuous Positive Airway Pressure (CPAP) therapy affects blood pressure over six months in people with obstructive sleep apnea (OSA), especially those who feel excessively sleepy. The main goal is to see if using CPAP can lower average blood pressure throughout the day in these patients. The trial is currently looking for participants aged 18 to 75 who have moderate to severe OSA and report feeling very sleepy. They also need to have a higher than normal blood pressure at the start of the study and be willing to use CPAP therapy.

If you qualify and decide to participate, you will use a CPAP machine to help you breathe while you sleep, which may improve your sleep quality and potentially lower your blood pressure. However, there are specific criteria that might prevent someone from joining, such as recent changes in blood pressure medications or certain heart and lung conditions. Overall, this study aims to understand the benefits of CPAP therapy not just for better sleep, but also for managing blood pressure in patients who struggle with excessive sleepiness due to OSA.

Gender

ALL

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