Effects of CPAP Therapy on Blood Pressure and Heart Rate Variability in Obstructive Sleep Apnea

NCT04712656 | Recruiting DMC

• 1 other identifier: 2020H0524
• Study Type: observational
• Target: 1,739
• Locations: 1 country
• Sites: 1

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

Keywords

Cardiovascular

Outcome Measures

Primary Outcomes (1)

• 24-hour Mean Blood Pressure

  24-hour Mean Blood Pressure obtained from ambulatory blood pressure monitoring (ABPM)

  Measurements will be conducted at baseline (prior to CPAP therapy) and 6-months after initiation of CPAP therapy.

Secondary Outcomes (1)

• Heart Rate Variability

  Measurements will be conducted at baseline (prior to CPAP therapy) and 6-months after initiation of CPAP therapy.

Study Arms (1)

OSA Subjects Treated with CPAP

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

Device: CPAP therapy

Interventions

CPAP therapy DEVICE

CPAP treatment of obstructive sleep apnea.

OSA Subjects Treated with CPAP

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults between the ages of 30 to 75 years old with moderate to severe obstructive sleep apnea (OSA). OSA diagnosis will be defined as an apnea/hypopnea index (AHI) \>or =5 episodes per hour.

You may qualify if:

• 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
• % oxygen desaturation index (ODI4) ≥15 events/hour on clinical sleep study
• Planned CPAP treatment by treating provider

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead
• University of Pennsylvania: collaborator
• Chang Gung Memorial Hospital: collaborator
• University of Sydney: collaborator
• The University of Western Australia: collaborator
• Peking University: collaborator
• Ruijin Hospital: collaborator
• National University of Singapore: collaborator
• University of Iceland: collaborator
• Geisinger Health: collaborator
• Charite University, Berlin, Germany: collaborator

Study Sites (1)

Martha Morehouse Medical Pavilion, Suite 2600

Columbus, Ohio, 43221, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Ulysses Magalang, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ALICIA GONZALEZ ZACARIAS, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 15, 2021
• Study Start: March 22, 2021
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): March 1, 2032
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)