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

Sponsor
Milton S. Hershey Medical Center (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT03062748
Collaborator
(none)
196
Enrollment
1
Location
69
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    196 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Predicting Cardiometabolic Risk in Mild-to-Moderate Obstructive Sleep Apnea: Inflammation vs. Apnea/Hypopnea Index
    Actual Study Start Date :
    Mar 1, 2017
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Dec 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. 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: 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 [baseline]

      AHI from one night polysomnography

    3. Markers of systemic inflammation [baseline]

      CRP, IL-6, TNFa

    Secondary Outcome Measures

    1. Heart rate variability [baseline]

      from polysomnography

    2. Subjective measure of sleepiness [baseline]

      Epworth Sleepiness Scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Penn State College of Medicine, Penn State Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033

    Sponsors and Collaborators

    • Milton S. Hershey Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alexandros Vgontzas, Professor, Milton S. Hershey Medical Center
    ClinicalTrials.gov Identifier:
    NCT03062748
    Other Study ID Numbers:
    • 5218
    First Posted:
    Feb 23, 2017
    Last Update Posted:
    Mar 4, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Apnea
    Sleep Apnea Syndromes
    Sleep Apnea, Obstructive
    Inflammation

    Study Results

    No Results Posted as of Mar 4, 2022