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

NCT ID: NCT03122483

Last Updated: 2017-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-07-14

Brief Summary

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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.

Detailed Description

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Conditions

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Obstructive Sleep Apnea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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OSA

Blood biomarker results in subjects with obstructive sleep apnea.

blood biomarker

Intervention Type DIAGNOSTIC_TEST

Non-OSA

Blood biomarker results in subjects without obstructive sleep apnea

blood biomarker

Intervention Type DIAGNOSTIC_TEST

Interventions

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blood biomarker

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Beckman Coulter, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paula C Southwick, PhD

Role: STUDY_DIRECTOR

Beckman Coulter, Inc.

Locations

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Sleep Center Orange County

Irvine, California, United States

Site Status

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

SleepMed

Columbia, South Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 27184708 (View on PubMed)

Other Identifiers

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SAB-03-15

Identifier Type: -

Identifier Source: org_study_id

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