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

• Conditions: Obstructive Sleep Apnea

• Registration Number: NCT03062748
• Lead Sponsor: Milton S. Hershey Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-16
• Study First Submitted QC: 2017-02-20
• Study First Posted: 2017-02-23
• Study Start: 2017-03-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-02
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 196

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Obstructive Sleep Apnea	baseline	AHI from one night polysomnography
Presence of the metabolic syndrome	baseline	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
Markers of systemic inflammation	baseline	CRP, IL-6, TNFa

Secondary Outcome Measures

Name	Time	Method
Subjective measure of sleepiness	baseline	Epworth Sleepiness Scale
Heart rate variability	baseline	from polysomnography

Trial Locations

Locations (1)

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States