Biomarkers in Obstructive Sleep Apnea Surgery
| Tracking Information | |||||
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| First Received Date ICMJE | July 23, 2007 | ||||
| Last Updated Date | May 18, 2012 | ||||
| Start Date ICMJE | June 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Leptin, homocysteine, and C-reactive protein levels. [ Time Frame: Before and after surgery ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00507078 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Biomarkers in Obstructive Sleep Apnea Surgery | ||||
| Official Title ICMJE | Biomarkers in Obstructive Sleep Apnea Surgery | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Obstructive Sleep Apnea | ||||
| Intervention ICMJE | Procedure: Surgical treatment for OSA | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 60 | ||||
| Completion Date | June 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00507078 | ||||
| Other Study ID Numbers ICMJE | 522315-38198 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Eric Kezirian, University of California, San Francisco | ||||
| Study Sponsor ICMJE | University of California, San Francisco | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of California, San Francisco | ||||
| Verification Date | May 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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