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

Effects of CPAP Therapy on Blood Pressure and Heart Rate Variability in Obstructive Sleep Apnea: Role of Symptom Subtypes

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep Apnea, Obstructive
• Intervention / Treatment: Device: CPAP therapy

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.

• Study Type: Observational
• Enrollment (Estimated): 1739

Contacts and Locations

• Study Contact: Name: ALICIA GONZALEZ ZACARIAS, MD; Phone Number: 614-366-2361; Email: Alicia.Gonzalezzacarias@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43221
      • Recruiting
      • Martha Morehouse Medical Pavilion, Suite 2600
      • Principal Investigator: Ulysses Magalang, MD
      • Contact: Ulysses Magalang, MD; Phone Number: 614-293-4925; Email: Ulysses.Magalang@osumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
OSA Subjects Treated with CPAP; Patients with moderate to severe OSA (ODI4>15/h) who accept CPAP therapy.	Device: CPAP therapy; CPAP treatment of obstructive sleep apnea.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate Variability	Heart Rate Variability obtained from 5-minute ECG	Measurements will be conducted at baseline (prior to CPAP therapy) and 6-months after initiation of CPAP therapy.

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: Peking University; University of Pennsylvania; Charite University, Berlin, Germany; Chang Gung Memorial Hospital; Ruijin Hospital; University of Iceland; University of Sydney; The University of Western Australia; Geisinger Health; National University of Singapore
• Investigators: Principal Investigator: Ulysses Magalang, MD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2021
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): March 1, 2032

Study Registration Dates

• First Submitted: January 13, 2021
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (Actual): January 15, 2021

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Cardiovascular
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 2020H0524

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No