Predicting Cardiometabolic Risk in Mild-to-Moderate Obstructive Sleep Apnea: Inflammation vs. Apnea/Hypopnea Index

The purpose of the study is to compare the relative contribution of systemic inflammation vs. Obstructive Sleep Apnea (OSA) severity (as measured by Apnea Hypopnea Index) in predicting cardiovascular and metabolic aberrations associated with mild-to-moderate obstructive sleep apnea.

Study Overview

• Status: Enrolling by invitation
• Conditions: Obstructive Sleep Apnea

• Study Type: Observational
• Enrollment (Estimated): 196

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients with suspected OS who are being seen at the Sleep Research and Treatment Center.

Description

Inclusion Criteria:

• Mild to moderate OSA (5≤ AHI <30)
• BMI ≤ 45
• Age ≥ 18
• Men & Women

Exclusion Criteria:

• AHI ≥ 30
• BMI >45
• Current use of steroids or anti-inflammatory medication
• Diagnosis of insulin dependent diabetes
• Diagnosis of autoimmune disorder
• Shiftwork
• Current use of CPAP

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of the metabolic syndrome	At least 3 of the following 5 risk factors must be met in order to have the metabolic syndrome: Elevated waist measurement (≥102 cm for men or ≥89 cm for women); Elevated triglycerides (≥150 mg/dL or use of medication); Low HDL cholesterol (<50 mg/dL for women or <40 mg/dL for men or use of medication); Elevated blood pressure (≥130 mmHg systolic or ≥ 85 mmHg diastolic or use of medication); Elevated fasting blood sugar (≥100 mg/dL or use of medication) Source: https://www.nhlbi.nih.gov/health/health-topics/topics/ms	baseline
Obstructive Sleep Apnea	AHI from one night polysomnography	baseline
Markers of systemic inflammation	CRP, IL-6, TNFa	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate variability	from polysomnography	baseline
Subjective measure of sleepiness	Epworth Sleepiness Scale	baseline

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 16, 2017
• First Submitted That Met QC Criteria: February 20, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; 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; Inflammation; Apnea
• Other Study ID Numbers: 5218

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