NCT04712656 · Ohio State University
Effects of CPAP Therapy on Blood Pressure and Heart Rate Variability in Obstructive Sleep Apnea
What this study 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.
View original scientific description
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.
Interventions
DEVICE
CPAP therapy
CPAP treatment of obstructive sleep apnea.
Primary outcome measures
24-hour Mean Blood Pressure
Time frame: Measurements will be conducted at baseline (prior to CPAP therapy) and 6-months after initiation of CPAP therapy.
24-hour Mean Blood Pressure obtained from ambulatory blood pressure monitoring (ABPM)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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)
- 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
Where
- Columbus, Ohio
Collaborators
University of Pennsylvania, Chang Gung Memorial Hospital, University of Sydney, The University of Western Australia, Peking University, Ruijin Hospital, National University of Singapore, University of Iceland, Geisinger Health, Charite University, Berlin, Germany
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 24, 2025 · Source of record for eligibility and locations