Use of Blood Biomarkers and Biomarker Index to Aid in the Diagnosis of Obstructive Sleep Apnea (OSA)

August 16, 2017 updated by: Beckman Coulter, Inc.
This multicenter prospective trial will evaluate the association between obstructive sleep apnea (OSA) and blood biomarkers in a representative population of consecutively enrolled symptomatic patients with a clinical suspicion of OSA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92604
        • Sleep Center Orange County
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • SleepMed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Symptomatic patients with a clinical suspicion of obstructive sleep apnea

Description

Inclusion Criteria:

  • Written Informed Consent
  • Male
  • 18-70 years old
  • Presentation with symptoms suggestive of obstructive sleep apnea
  • Diagnostic sleep study
  • Blood draw

Exclusion Criteria:

  • Prior (within past year) or current therapy for sleep apnea
  • Use of opioid pain medication, steroids or allopurinol (within past 30 days)
  • Use of chronic anti-inflammatory drugs (within past 7 days)
  • Active cancer under current treatment or monitoring

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
OSA
Blood biomarker results in subjects with obstructive sleep apnea.
Diagnostic test: blood biomarker
Non-OSA
Blood biomarker results in subjects without obstructive sleep apnea
Diagnostic test: blood biomarker

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of OSA in high-risk individuals
Time Frame: 1 day
Identification of OSA in high-risk individuals
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beckman Coulter, Inc.

Investigators

  • Study Director: Paula C Southwick, PhD, Beckman Coulter, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

July 14, 2017

Study Completion (Actual)

July 14, 2017

Study Registration Dates

First Submitted

April 17, 2017

First Submitted That Met QC Criteria

April 18, 2017

First Posted (Actual)

April 20, 2017

Study Record Updates

Last Update Posted (Actual)

August 18, 2017

Last Update Submitted That Met QC Criteria

August 16, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAB-03-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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