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

N/AEnrolling By InvitationNCT03062748

Milton S. Hershey Medical Center196 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

196

Conditions

Obstructive Sleep Apnea

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Outcomes

Primary Outcomes

Presence of the metabolic syndrome

At least 3 of the following 5 risk factors must be met in order to have the metabolic syndrome: 1. Elevated waist measurement (≥102 cm for men or ≥89 cm for women) 2. Elevated triglycerides (≥150 mg/dL or use of medication) 3. Low HDL cholesterol (\<50 mg/dL for women or \<40 mg/dL for men or use of medication) 4. Elevated blood pressure (≥130 mmHg systolic or ≥ 85 mmHg diastolic or use of medication) 5. Elevated fasting blood sugar (≥100 mg/dL or use of medication) Source: https://www.nhlbi.nih.gov/health/health-topics/topics/ms

Time frame: baseline

Obstructive Sleep Apnea

AHI from one night polysomnography

Time frame: baseline

Markers of systemic inflammation

CRP, IL-6, TNFa

Time frame: baseline

Secondary Outcomes

Heart rate variability

from polysomnography

Time frame: baseline

Subjective measure of sleepiness

Epworth Sleepiness Scale

Time frame: baseline

Data from ClinicalTrials.gov

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