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NCT03122483 Clinical Trial

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

Obstructive Sleep Apnea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03122483
Other study ID # SAB-03-15
Secondary ID
Status Completed
Phase N/A
First received April 17, 2017
Last updated August 16, 2017
Start date January 2016
Est. completion date July 14, 2017

Study information
Verified date August 2017
Source Beckman Coulter, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 250
Est. completion date July 14, 2017
Est. primary completion date July 14, 2017
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 70 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• blood biomarker

Locations
Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts
United States SleepMed Columbia South Carolina
United States Sleep Center Orange County Irvine California

Sponsors (1)
Lead Sponsor Collaborator
Beckman Coulter, Inc.

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Identification of OSA in high-risk individuals Identification of OSA in high-risk individuals 1 day
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