Recruiting

CPAP Therapy

Sponsor:

Ohio State University

Code:

NCT04712656

Conditions

Sleep Apnea, Obstructive

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

CPAP therapy

Study Details

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 apnea (OSA) varies between symptom phenotypes.

Conditions

Sleep Apnea, Obstructive

Study ID

NCT04712656

Start date

Mar 22, 2021

Status verified date

Jul, 2025

Completion date

Mar 1, 2032

Anticipated

Primary completion date

Mar 1, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1739 participants

Anticipated

Interventions and Outcome Measures

Arms

OSA Subjects Treated with CPAP

Patients with moderate to severe OSA (ODI4>15/h) who accept CPAP therapy.

Interventions

CPAP therapy

CPAP treatment of obstructive sleep apnea.

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

ALICIA GONZALEZ ZACARIAS, MD

614-366-2361Alicia.Gonzalezzacarias@osumc.edu

Locations

Martha Morehouse Medical Pavilion, Suite 2600

Recruiting

Columbus, Ohio, United States, 43221

Contacts

Ulysses Magalang, MD

(614) 293-4925Ulysses.Magalang@osumc.edu

Principal Investigator:

Ulysses Magalang, MD

More Information

Sponsor

Ohio State University

Last update posted

Jul 24, 2025

Last verified

Jul, 2025

Keywords

  • Cardiovascular

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2025-07-24.