Measuring Effectiveness in Sleep Apnea Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obstructive Sleep Apnea
- Sponsor
- University of California, San Francisco
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- C-reactive protein level
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The goal of this research is to improve our understanding of the effectiveness of surgical OSA treatment by evaluating its impact on these health-related and functional outcomes and comparing these effects to the changes in respiratory physiology achieved after surgery. To achieve this goal, we will examine key health-related (C-reactive protein, homocysteine, leptin, the homeostasis model of insulin resistance, and heart rate variability) and functional (sleep-related quality of life and vigilance) measures among a surgical group of OSA patients who do not tolerate non-surgical treatment (positive airway pressure, PAP) and a comparison group of matched OSA patients who tolerate PAP.
Detailed Description
The goal of this research is to improve our understanding of the effectiveness of surgical OSA treatment by evaluating its impact on these health-related and functional outcomes and comparing these effects to the changes in respiratory physiology achieved after surgery. To achieve this goal, we will examine key health-related (C-reactive protein, homocysteine, leptin, the homeostasis model of insulin resistance, and heart rate variability) and functional (sleep-related quality of life and vigilance) measures among a surgical group of OSA patients who do not tolerate non-surgical treatment (positive airway pressure, PAP) and a comparison group of matched OSA patients who tolerate PAP. We propose to measure the impact of surgical OSA treatment on these health-related and functional outcomes measures with the following three analyses: (1) to assess the changes seen with surgical treatment; (2) to compare changes seen with surgical and PAP treatment; and (3) to evaluate the association between changes in respiratory patterns during sleep and changes in health-related and functional outcomes measures for both surgical and PAP treatment.
Investigators
Eric Kezirian
Associate Professor, Department of Otolaryngology--Head and Neck Surgery
University of California, San Francisco
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Pregnant women
- •Primary snoring or mild OSA (apnea-hypopnea index \< 15)
- •Known neurologic, cardiac, hepatic, or renal disorder
- •Acute illness or infection
- •Co-existing sleep disorder other than primary snoring
- •Unable to fast overnight prior to blood draw
Outcomes
Primary Outcomes
C-reactive protein level
Time Frame: Before and after surgery
Secondary Outcomes
- Leptin, Homocysteine, Homeostasis model of insulin resistance (HOMA-IR), Heart rate variability, Functional Outcomes of Sleep Questionnaire and Psychomotor Vigilance Task.(Before and after surgery)