RecruitingNCT04712656

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

Effects of CPAP Therapy on Blood Pressure and Heart Rate Variability in Obstructive Sleep Apnea: Role of Symptom Subtypes

Sponsor

Ohio State University

Enrollment

1,739 participants

Start Date

Mar 22, 2021

Study Type

OBSERVATIONAL

Conditions

Sleep Apnea, Obstructive

Summary

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.

Eligibility

Min Age: 30 YearsMax Age: 75 Years

Inclusion Criteria7

to 75 years of age
Among patients with hypertension, no change in BP 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 \[Polysomnography (PSG) or Home Sleep Apnea Study (HSAT) performed based on clinical grounds
% oxygen desaturation index (ODI4) ≥15 events/hour on clinical sleep study
Planned CPAP treatment by treating provider

Exclusion Criteria13

Unable to apply BP cuff (e.g. arm circumference >55 cm, prior breast cancer, structural abnormalities of the arm)
Current use of CPAP or Dental Device for OSA
Category III-IV of heart failure
Presence of Cheyne-Stokes Respiration (CSR) in PSG
Predominantly central sleep apnea (AHI≥15 events/hour)
Pregnancy
History of renal failure, or renal transplant
Self-reported sleep duration less than 5 hours per night on weeknights (work nights)
Other sleep disorders
Use of supplemental oxygen during wakefulness or sleep
Self-reported illicit drug use or marijuana use more than once per week
Unstable medical conditions: uncontrolled angina, uncontrolled hypertension, severe chronic obstructive pulmonary disease, active cancer, or unstable psychiatric disease
Any underlying condition that, in the opinion of the lead investigator, prohibits participation in the study