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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03062748
• Other study ID #: 5218
• Status: Enrolling by invitation
• Start date: March 1, 2017
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 196
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Inflammation
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
United States	Penn State College of Medicine, Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Obstructive Sleep Apnea	AHI from one night polysomnography	baseline
Primary	Markers of systemic inflammation	CRP, IL-6, TNFa	baseline
Secondary	Heart rate variability	from polysomnography	baseline
Secondary	Subjective measure of sleepiness	Epworth Sleepiness Scale	baseline