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Biomarkers in Obstructive Sleep Apnea Surgery

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ClinicalTrials.gov Identifier: NCT00507078
Recruitment Status : Completed
First Posted : July 25, 2007
Last Update Posted : May 21, 2012
Sponsor:
Information provided by (Responsible Party):
Eric Kezirian, University of California, San Francisco

Brief Summary:
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 or disease Intervention/treatment Phase
Obstructive Sleep Apnea Procedure: Surgical treatment for OSA Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Biomarkers in Obstructive Sleep Apnea Surgery
Study Start Date : June 2005
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea




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


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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.

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

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 Posted: July 25, 2007    Key Record Dates
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