Status:
RECRUITING
Effects of CPAP Therapy on Blood Pressure and Heart Rate Variability in Obstructive Sleep Apnea
Lead Sponsor:
Ohio State University
Collaborating Sponsors:
University of Pennsylvania
Chang Gung Memorial Hospital
Conditions:
Sleep Apnea, Obstructive
Eligibility:
All Genders
30-75 years
Brief 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 apne...
Detailed Description
This is a prospective, non-randomized, multi-center, cohort study involving patients with moderate to severe OSA. This study will compare OSA patients who accept and comply with CPAP therapy versus th...
Eligibility Criteria
Inclusion
- 30 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
- 4% oxygen desaturation index (ODI4) ≥15 events/hour on clinical sleep study
- Planned CPAP treatment by treating provider
Exclusion
- 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
- Development or adoption of any of the above exclusion criteria during the study period
Key Trial Info
Start Date :
March 22 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2032
Estimated Enrollment :
1739 Patients enrolled
Trial Details
Trial ID
NCT04712656
Start Date
March 22 2021
End Date
March 1 2032
Last Update
July 24 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Martha Morehouse Medical Pavilion, Suite 2600
Columbus, Ohio, United States, 43221