Impact of CPAP Therapy on Blood Pressure and Heart Rate in Sleep Apnea Patients
Effects of CPAP Therapy on Blood Pressure and Heart Rate Variability in Obstructive Sleep Apnea: Role of Symptom Subtypes
This study is testing if using CPAP therapy helps lower blood pressure and heart rate in people with moderate to severe sleep apnea compared to those who don’t use it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1739 (estimated) |
| Ages | 30 Years to 75 Years |
| Sex | All |
| Sponsor | Ohio State University Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT04712656 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess how continuous positive airway pressure (CPAP) therapy affects 24-hour mean blood pressure in patients with moderate to severe obstructive sleep apnea (OSA). It will compare patients who adhere to CPAP therapy with those who do not, using a multi-center cohort design. Participants will undergo various assessments, including blood pressure monitoring, ECG, and blood tests, over a six-month period, with follow-up interviews conducted annually for ten years to track health outcomes. The study will utilize a propensity score design to address potential biases in the non-randomized comparison.
Who should consider this trial
Good fit: Ideal candidates are adults aged 30 to 75 with moderate to severe obstructive sleep apnea and hypertension who are willing to comply with CPAP therapy.
Not a fit: Patients currently using CPAP or those with central sleep apnea or significant heart failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into optimizing CPAP therapy for better cardiovascular outcomes in patients with obstructive sleep apnea.
How similar studies have performed: Other studies have shown promising results regarding the cardiovascular benefits of CPAP therapy in obstructive sleep apnea, indicating that this approach is supported by existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
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) * 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
Where this trial is running
Columbus, Ohio
- Martha Morehouse Medical Pavilion, Suite 2600 — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Ulysses Magalang, MD — Ohio State University
- Study coordinator: Alicia Gonzalez Zacarias, Md
- Email: Alicia.Gonzalezzacarias@osumc.edu
- Phone: 614-366-2361
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.