RecruitingNCT05742360

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

Sponsor

Ohio State University

Enrollment

227 participants

Start Date

Feb 7, 2023

Study Type

OBSERVATIONAL

Conditions

Obstructive Sleep Apnea

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria6

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 Criteria11

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