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Biomarkers in Obstructive Sleep Apnea Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00507078
First Posted: July 25, 2007
Last Update Posted: May 21, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eric Kezirian, University of California, San Francisco
  Purpose
Recent years have witnessed major advances in the understanding of the hormonal, metabolic, and biochemical changes that occur in obstructive sleep apnea (OSA). This project evaluates the biomarkers that measure the most significant health impacts of this disorder and creates a specimen bank that will facilitate evaluations of additional biomarkers in the future.

Condition Intervention
Obstructive Sleep Apnea Procedure: Surgical treatment for OSA

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Biomarkers in Obstructive Sleep Apnea Surgery

Resource links provided by NLM:


Further study details as provided by Eric Kezirian, University of California, San Francisco:

Primary Outcome Measures:
  • Leptin, homocysteine, and C-reactive protein levels. [ Time Frame: Before and after surgery ]

Enrollment: 60
Study Start Date: June 2005
Study Completion Date: June 2007
Detailed Description:

This is a case-control study to examine the relationship between obstructive sleep apnea (OSA) and elevated levels of leptin, homocysteine, and C-reactive protein (CRP) in moderate or severe OSA and control patients. This is followed by a prospective cohort study to examine the relationship between surgical treatment of moderate or severe OSA and serum levels of these biomarkers.

The short-term goals of this study consider the abnormalities in biomarker levels associated with OSA and specific aspects of the disorder as well as whether the changes seen after surgical treatment of OSA mirror those demonstrated after efficacious non-surgical treatment. The long term goals are in two areas: 1) the development of measures to determine which patients require treatment for sleep-disordered breathing and to monitor the effectiveness of therapy, and 2) a deeper understanding of the connection between OSA and its adverse health consequences.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • OSA group is adults with moderate or severe OSA (apnea >= 15 based on preoperative sleep study) undergoing surgical treatment. Assessment is done prior to surgery.
  • Control group is overweight (body mass >25) adults without OSA (apnea-hypopnea index <5 based on sleep study) or other sleep disorders. Assessment is prior to treatment.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00507078


Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Eric Kezirian, MD, MPH University of California, San Francisco
  More Information

Responsible Party: Eric Kezirian, Associate Professor, Director of Sleep Surgery, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00507078     History of Changes
Other Study ID Numbers: 522315-38198
First Submitted: July 23, 2007
First Posted: July 25, 2007
Last Update Posted: May 21, 2012
Last Verified: May 2012

Keywords provided by Eric Kezirian, University of California, San Francisco:
Obstructive Sleep Apnea
Leptin
Homocysteine
C-reactive Protein

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases


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