Effect of CPAP on Blood Pressure in Excessively Sleepy Obstructive Sleep Apnea Subtype

Effect of CPAP on 24-Hour Blood Pressure in the Excessively Sleepy Obstructive Sleep Apnea Subtype

The primary objective of this study is to determine the longer-term (6 months) effect of CPAP therapy on change in 24-hour mean blood pressure (24hMBP) in OSA subjects with the excessively sleepy symptom subtype.

Study Overview

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

Detailed Description

This is a prospective, non-randomized, observational, two-center study involving newly diagnosed subjects with moderate-severe OSA with the excessively sleepy symptom subtype.

Variables of Interest: Change in 24-hour ambulatory BP, change in sitting BP, change in reaction time by psychomotor vigilance test (PVT)

Participants will complete questionnaires that pertain to demographics, lifestyle factors, and co-morbidities. The blood samples will be used to determine levels of BP medications and serum creatinine. Measurements will be collected at baseline and at 6-month follow-up visits.

Data Analysis Approach: To correct for potential bias in the non-randomized comparison, the investigators 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, including age, sex, obesity (BMI, neck circumference, waist-to-hip ratio), current smoking, history of hypertension, 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): 227

Contacts and Locations

• Study Contact: Name: Alicia Gonzalez Zacarias, MD; Phone Number: 6143662361; Email: alicia.gonzalezzacarias@osumc.edu
• Study Contact Backup: Name: Joseph Santiago, RRT; Phone Number: 6143664756; Email: joseph.santiago@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43221
      • Recruiting
      • The Ohio State University - Martha Morehouse Medical Pavilion, Suite 2600
      • Contact: Alicia Gonzalez Zacarias, MD; Phone Number: 6143662361; Email: alicia.gonzalezzacarias@osumc.edu
      • Contact: Joseph Santiago, RRT; Phone Number: 6143664756; Email: joseph.santiago@osumc.edu
      • Principal Investigator: Ulysses Magalang, MD
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Contact: Colleen Walsh; Phone Number: 2157464806; Email: walshco@pennmedicine.upenn.edu
      • Contact: Allan I Pack, MBChB; Phone Number: 2157464806; Email: pack@pennmedicine.upenn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adults between the ages of 18 to 75 years old with moderate-severe obstructive sleep apnea (OSA) with excessively sleepy symptom subtype. OSA diagnosis will be defined as an apnea/hypopnea index (AHI) >or =5 episodes per hour.

Description

Inclusion Criteria:

• Age 18-75 years
• Moderate-severe OSA (defined as ODI ≥10 events/hour) via Polysomnography (PSG) or Home Sleep Apnea Study (HSAT) done based on clinical grounds
• Excessively sleepy subtype determined by patient-reported symptoms
• Willing to accept CPAP therapy
• An elevated baseline office BP defined as ≥120 or ≥80 mmHg
• Planned PAP (CPAP or bi-level PAP) treatment by treating provider

Exclusion Criteria:

• Recent changes (within 3 months) to BP medications among those who are on these medications
• Unable to apply ABPM cuff
• Current use of CPAP or other OSA treatments
• Resting, awake SaO2 <90% or use of home oxygen therapy
• New York Heart Association (NYHA) categories III-IV of heart failure
• Presence of Cheyne-Stokes Respiration (CSR) in sleep study identified by typical crescendo-decrescendo pattern of respiration with associated apneas and/or hypopneas in the absence of inspiratory flow limitation
• Predominantly central sleep apnea (AHI≥15 events/hour, with >50% central events [apnea or hypopnea])
• Life expectancy <2 years
• Pregnancy
• Clinical history of chronic kidney disease (Stage 5) requiring dialysis, or renal transplant
• Systolic BP > 180 mmHg

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
OSA subjects with the excessively sleepy symptom subtype treated with CPAP; Patients with the excessively sleepy symptom subtype who accept CPAP therapy	Device: CPAP therapy; CPAP treatment of obstructive sleep apnea with the excessively sleepy symptom subtype

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 24-hour Mean Blood Pressure	24-hour Mean Blood Pressure obtained from ambulatory blood pressure monitoring (ABPM)	Change from baseline 24-hour Mean Blood Pressure at 6-months after initiation of CPAP therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nocturnal Mean BP	Nocturnal Mean Blood Pressure obtained from ambulatory blood pressure monitoring (ABPM)	Change from baseline nocturnal Mean Blood Pressure at 6-months after initiation of CPAP therapy
Reciprocal of Reaction Time	Reciprocal of reaction time obtained by Psychomotor Vigilance Test	Change from baseline reaction time at 6-months after initiation of CPAP therapy

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: University of Pennsylvania
• Investigators: Principal Investigator: Ulysses Magalang, MD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: January 26, 2023
• First Submitted That Met QC Criteria: February 20, 2023
• First Posted (Actual): February 24, 2023

Study Record Updates

• Last Update Posted (Actual): August 13, 2025
• Last Update Submitted That Met QC Criteria: August 8, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Excessively Sleepy Symptom Subtype
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 2022H0323

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
• product manufactured in and exported from the U.S.: No