Use of Blood Biomarkers and Biomarker Index to Aid in the Diagnosis of Obstructive Sleep Apnea (OSA)
1 other identifier
observational
250
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2016
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 17, 2017
CompletedFirst Posted
Study publicly available on registry
April 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 14, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 14, 2017
CompletedAugust 18, 2017
August 1, 2017
1.5 years
April 17, 2017
August 16, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Identification of OSA in high-risk individuals
Identification of OSA in high-risk individuals
1 day
Study Arms (2)
OSA
Blood biomarker results in subjects with obstructive sleep apnea.
Non-OSA
Blood biomarker results in subjects without obstructive sleep apnea
Interventions
Eligibility Criteria
Symptomatic patients with a clinical suspicion of obstructive sleep apnea
You may qualify if:
- Written Informed Consent
- Male
- years old
- Presentation with symptoms suggestive of obstructive sleep apnea
- Diagnostic sleep study
- Blood draw
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Sleep Center Orange County
Irvine, California, 92604, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
SleepMed
Columbia, South Carolina, 29201, United States
Related Publications (1)
Fleming WE, Ferouz-Colborn A, Samoszuk MK, Azad A, Lu J, Riley JS, Cruz AB, Podolak S, Clark DJ, Bray KR, Southwick PC. Blood biomarkers of endocrine, immune, inflammatory, and metabolic systems in obstructive sleep apnea. Clin Biochem. 2016 Aug;49(12):854-61. doi: 10.1016/j.clinbiochem.2016.05.005. Epub 2016 May 13.
PMID: 27184708BACKGROUND
Biospecimen
Whole blood and serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Paula C Southwick, PhD
Beckman Coulter, Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2017
First Posted
April 20, 2017
Study Start
January 1, 2016
Primary Completion
July 14, 2017
Study Completion
July 14, 2017
Last Updated
August 18, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share