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

NCT03062748 | Enrolling By Invitation

• 1 other identifier: 5218
• Study Type: observational
• Target: 196
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (3)

• 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

  baseline

• Obstructive Sleep Apnea

  AHI from one night polysomnography

  baseline

• Markers of systemic inflammation

  CRP, IL-6, TNFa

  baseline

Secondary Outcomes (2)

• Heart rate variability

  baseline

• Subjective measure of sleepiness

  baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

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

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: February 23, 2017
• Study Start: March 1, 2017
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)