Impact of CPAP on Blood Pressure in Sleepy Obstructive Sleep Apnea Patients

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

This study is testing if using CPAP therapy can help lower blood pressure in people with moderate to severe obstructive sleep apnea who are very sleepy.

Quick facts

• Study type: Observational
• Enrollment: 227 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Ohio State University (Academic / other)
• Locations: 2 sites (Columbus, Ohio and 1 other locations)
• Trial ID: NCT05742360 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the long-term effects of CPAP therapy on blood pressure in patients diagnosed with moderate to severe obstructive sleep apnea (OSA) who exhibit excessive sleepiness. Participants will undergo a comprehensive evaluation, including questionnaires on demographics and lifestyle, as well as blood pressure measurements at baseline and after six months of CPAP treatment. The study will utilize a propensity score design to account for potential biases in the non-randomized comparison of outcomes. Key variables of interest include changes in 24-hour mean blood pressure and psychomotor vigilance.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with moderate to severe obstructive sleep apnea and excessive sleepiness who are willing to undergo CPAP therapy.

Not a fit: Patients currently using CPAP or other OSA treatments, or those with specific heart failure conditions, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved blood pressure management in patients with obstructive sleep apnea, enhancing overall cardiovascular health.

How similar studies have performed: Previous studies have shown promising results in the management of blood pressure through CPAP therapy in OSA patients, indicating that this approach has potential for success.

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

Where this trial is running

Columbus, Ohio and 1 other locations

• The Ohio State University - Martha Morehouse Medical Pavilion, Suite 2600 — Columbus, Ohio, United States (Recruiting)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: Ulysses Magalang, MD — Ohio State University
• Study coordinator: Alicia Gonzalez Zacarias, MD

Conditions Obstructive Sleep Apnea; Excessively Sleepy Symptom Subtype