Actively Recruiting

Age: 30Years - 75Years
All Genders
NCT04712656

Effects of CPAP Therapy on Blood Pressure and Heart Rate Variability in Obstructive Sleep Apnea

Led by Ohio State University · Updated on 2025-07-24

1739

Participants Needed

1

Research Sites

571 weeks

Total Duration

On this page

Sponsors

O

Ohio State University

Lead Sponsor

U

University of Pennsylvania

Collaborating Sponsor

AI-Summary

What this Trial Is About

The primary objective of this study is to determine whether the effect of continuous positive airway pressure (CPAP) therapy on 24-hour mean blood pressure (BP) in patients with obstructive sleep apnea (OSA) varies between symptom phenotypes.

CONDITIONS

Official Title

Effects of CPAP Therapy on Blood Pressure and Heart Rate Variability in Obstructive Sleep Apnea

Who Can Participate

Age: 30Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 30 and 75 years
  • For patients with hypertension, no changes in blood pressure medication for at least 3 months
  • Willing and able to give informed consent
  • Willing and able to complete ambulatory blood pressure monitoring at baseline and after 6 months
  • Sleep study performed (Polysomnography or Home Sleep Apnea Study) based on clinical needs
  • 4% oxygen desaturation index (ODI4) of 15 or more events per hour on sleep study
  • Planned CPAP treatment by treating provider
Not Eligible

You will not qualify if you...

  • Unable to apply blood pressure cuff due to arm circumference greater than 55 cm, prior breast cancer, or arm structural abnormalities
  • Current use of CPAP or dental device for obstructive sleep apnea
  • Heart failure category III or IV
  • Presence of Cheyne-Stokes Respiration on sleep study
  • Predominantly central sleep apnea with apnea-hypopnea index of 15 or more events per hour
  • Pregnancy
  • History of renal failure or renal transplant
  • Self-reported sleep duration less than 5 hours per night on weeknights
  • Other sleep disorders
  • Use of supplemental oxygen during wakefulness or sleep
  • Self-reported illicit drug or marijuana use more than once per week
  • Unstable medical conditions such as uncontrolled angina, uncontrolled hypertension, severe chronic obstructive pulmonary disease, active cancer, or unstable psychiatric disease
  • Any condition that the lead investigator considers prohibitive for study participation
  • Development or adoption of any exclusion criteria during the study period

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Martha Morehouse Medical Pavilion, Suite 2600

Columbus, Ohio, United States, 43221

Actively Recruiting

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Research Team

A

ALICIA GONZALEZ ZACARIAS, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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