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RECRUITINGOBSERVATIONAL

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

Effect of CPAP on 24-Hour Blood Pressure in the Excessively Sleepy Obstructive Sleep Apnea Subtype

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DEVICE

CPAP therapy

CPAP treatment of obstructive sleep apnea with the excessively sleepy symptom subtype

Locations (2)

The Ohio State University - Martha Morehouse Medical Pavilion, Suite 2600
Columbus, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States