Biomarkers in Obstructive Sleep Apnea Surgery

Obstructive Sleep Apnea Clinical Trial

Official title:

Biomarkers in Obstructive Sleep Apnea Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00507078
• Other study ID #: 522315-38198
• Status: Completed
• Phase: N/A
• First received: July 23, 2007
• Last updated: May 18, 2012
• Start date: June 2005
• Est. completion date: June 2007

Study information

• Verified date: May 2012
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Procedure:
• Surgical treatment for OSA

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Leptin, homocysteine, and C-reactive protein levels.		Before and after surgery