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Enrolling by Invitation

NCT Number: NCT03062748

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Hershey, Pennsylvania, 17033, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Presence of the metabolic syndrome

    Time frame: baseline

    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

  2. Obstructive Sleep Apnea

    Time frame: baseline

    AHI from one night polysomnography

  3. Markers of systemic inflammation

    Time frame: baseline

    CRP, IL-6, TNFa

Secondary outcomes

  1. Heart rate variability

    Time frame: baseline

    from polysomnography

  2. Subjective measure of sleepiness

    Time frame: baseline

    Epworth Sleepiness Scale

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Feb 23, 2017
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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