Skip to content

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

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03062748
Enrollment
196
Registered
2017-02-23
Start date
2017-03-01
Completion date
2027-12-01
Last updated
2026-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

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.

Interventions

None listed

Sponsors

Milton S. Hershey Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Presence of the metabolic syndromebaselineAt 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
Obstructive Sleep ApneabaselineAHI from one night polysomnography
Markers of systemic inflammationbaselineCRP, IL-6, TNFa

Secondary

MeasureTime frameDescription
Heart rate variabilitybaselinefrom polysomnography
Subjective measure of sleepinessbaselineEpworth Sleepiness Scale

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 24, 2026