Actively Recruiting
Effects of CPAP Therapy on Blood Pressure and Heart Rate Variability in Obstructive Sleep Apnea: Role of Symptom Subtypes
Led by Ohio State University · Updated on 2025-07-24
1739
Participants Needed
1
Research Sites
52 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
Researchers are studying how continuous positive airway pressure (CPAP) therapy affects 24-hour average blood pressure in patients with obstructive sleep apnea (OSA), focusing on whether responses vary by different symptom types. This observational, multi-center study involves adults aged 30 to 75 with moderate to severe OSA. The study compares patients who use CPAP therapy as prescribed with those who do not, aiming to better understand cardiovascular outcomes related to OSA treatment. Participants diagnosed with OSA and prescribed CPAP will be followed over time. Key measurements include 24-hour ambulatory blood pressure, sitting blood pressure, heart rate variability via electrocardiogram, facial photographs, psychomotor vigilance tests, questionnaires on lifestyle and co-existing conditions, and blood samples for markers related to diabetes, heart injury, inflammation, coagulation, and genetics. These assessments occur at the start of the study and again after six months of CPAP therapy. The study uses statistical methods to account for differences between those who adhere to CPAP and those who do not. During the study, participants complete questionnaires about demographics, lifestyle, and cardiovascular disease risks, and blood pressure monitoring is performed. They will be contacted yearly by phone for up to ten years to update information on OSA treatment use, new health problems like heart attacks or strokes, and medication changes. Researchers will analyze blood pressure changes and heart rate variability before and after CPAP therapy to evaluate its effects. The total follow-up includes initial assessments, six-month visits, and long-term telephone monitoring.
CONDITIONS
Brief Title
Effects of CPAP Therapy on Blood Pressure and Heart Rate Variability in Obstructive Sleep Apnea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 30 and 75 years
- Patients with hypertension must have no change in blood pressure medication for at least 3 months
- Willing and able to give informed consent
- Able to complete ambulatory blood pressure monitoring at baseline and after 6 months
- Sleep study performed showing 4% oxygen desaturation index (ODI4) of 15 or more events per hour
- Planned CPAP treatment prescribed by a healthcare provider
You will not qualify if you...
- Unable to apply blood pressure cuff due to arm size or structural issues
- Current use of CPAP or dental device for obstructive sleep apnea
- Severe heart failure (category III-IV)
- Presence of Cheyne-Stokes Respiration on sleep study
- Predominantly central sleep apnea (AHI 15 or more events per hour)
- Pregnancy
- History of kidney failure or kidney transplant
- Self-reported sleep less than 5 hours per night on work nights
- Other sleep disorders
- Use of supplemental oxygen while awake or asleep
- Illicit drug or marijuana use more than once per week
- Unstable medical conditions such as uncontrolled angina, hypertension, severe COPD, active cancer, or psychiatric disease
- Any condition that prevents safe participation as decided by the lead investigator
- Development of exclusion conditions during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants who accept CPAP therapy are observed to assess the effects of CPAP treatment on blood pressure and heart rate variability.
2 visits (in-person) at baseline and 6 months
Duration - Up to 10 years
Participants are contacted annually by telephone for up to 10 years to monitor treatment use and any new health problems.
Annual telephone interviews
Trial Site Locations
Total: 1 location
1
Martha Morehouse Medical Pavilion, Suite 2600
Columbus, Ohio, United States, 43221
Actively Recruiting
Research Team
A
ALICIA GONZALEZ ZACARIAS, MD
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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