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Biomarkers in Obstructive Sleep Apnea Surgery

Biomarkers in Obstructive Sleep Apnea Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00507078
Enrollment
60
Registered
2007-07-25
Start date
2005-06-30
Completion date
2007-06-30
Last updated
2012-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep Apnea, Leptin, Homocysteine, C-reactive Protein

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.

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.

Interventions

PROCEDURESurgical treatment for OSA

Sponsors

University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Leptin, homocysteine, and C-reactive protein levels.Before and after surgery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026