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Enrolling by invitation NCT03062748

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

— Observational Obstructive Sleep Apnea

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Obstructive Sleep Apnea. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • Presence of the metabolic syndrome [Time frame: baseline]
  • Obstructive Sleep Apnea [Time frame: baseline]
  • Markers of systemic inflammation [Time frame: baseline]
Secondary outcome measures (2)
  • Heart rate variability [Time frame: baseline]
  • Subjective measure of sleepiness [Time frame: baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • Penn State College of Medicine, Penn State Milton S. Hershey Medical Center — Hershey

Identifiers

NCT: NCT03062748 · 5218

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗