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

NCT ID: NCT04712656

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1739 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-22
• Study Completion Date: 2032-03-01

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.

Detailed Description

This is a prospective, non-randomized, multi-center, cohort study involving patients with moderate to severe OSA. This study will compare OSA patients who accept and comply with CPAP therapy versus those who do not.

Variables of Interest: 24-hour ambulatory BP, sitting BP, electrocardiogram (ECG), facial photographs, psychomotor vigilance test (PVT), questionnaires, and blood samples.

Patients will complete questionnaires that pertain to demographics, lifestyle factors, and co-morbidities associated with CVD. The blood samples will be used to look for evidence of diabetes; elevated lipids; markers of heart injury, inflammation, and coagulation; and genetic information. Measurements will be collected at baseline and at 6-month follow-up.

In addition, patients enrolled in this study will be contacted by telephone once a year over a ten year period. The purpose of the telephone interview is to determine if they are using any treatment for OSA, if they have developed any new health problems such as a heart attack or stroke, and if they have changed any of their usual medications.

Data Analysis Approach: To correct for potential bias in the non-randomized comparison, we will apply a Propensity Score (PS) Design via subclassification. Models to derive the PS values used in this design will include a number of covariates relevant to CPAP adherence and cardiovascular outcomes, including age, sex, obesity (BMI, neck circumference, waist-to-hip ratio), current smoking, prevalent CVD at baseline, history of hypertension, HbA1c, diabetes mellitus (history, medications), lipid profile, hyperlipidemia (history, medications), family history of premature coronary disease, Charlson comorbidity index, physical activity (IPAQ), diet, OSA severity (AHI, ODI4, T90), sleepiness (Epworth Sleepiness Scale), educational attainment, socioeconomic status (postcode), insomnia symptoms (Insomnia Symptom Questionnaire), anxiety and depression-related symptoms (Patient Health Questionnaire-2), self-efficacy (General self-efficacy scale), and medication adherence (Medication Adherence Report Scale [MARS-5]). Baseline values of outcome measures will also be included in the PS model. After creating the PS design, all analyses are performed accounting for PS subclass as a categorical stratification factor. Evaluations of the CPAP effect on binary outcomes are performed utilizing conditional logistic regression. Similarly, CPAP effects in the context of survival analyses (e.g., Cox Proportional Hazards models) or on continuous outcomes (e.g., linear regression) are assessed by including PS subclass as a categorical covariate in all models.

Conditions

Sleep Apnea, Obstructive

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

OSA Subjects Treated with CPAP

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

CPAP therapy

Intervention Type: DEVICE

CPAP treatment of obstructive sleep apnea.

Interventions

CPAP therapy

CPAP treatment of obstructive sleep apnea.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role: collaborator

University of Sydney

OTHER

Sponsor Role: collaborator

The University of Western Australia

OTHER

Sponsor Role: collaborator

Peking University

OTHER

Sponsor Role: collaborator

Ruijin Hospital

OTHER

Sponsor Role: collaborator

National University of Singapore

OTHER

Sponsor Role: collaborator

University of Iceland

OTHER

Sponsor Role: collaborator

Geisinger Health

UNKNOWN

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Ulysses Magalang MD

Professor of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ulysses Magalang, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

Martha Morehouse Medical Pavilion, Suite 2600

Columbus, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

ALICIA GONZALEZ ZACARIAS, MD

Role: CONTACT

Alicia.Gonzalezzacarias@osumc.edu

614-366-2361

Facility Contacts

Ulysses Magalang, MD

Role: primary

Ulysses.Magalang@osumc.edu

(614) 293-4925

Other Identifiers

2020H0524

Identifier Type: -

Identifier Source: org_study_id