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
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