Measuring Effectiveness in Sleep Apnea Surgery

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Procedure: Surgical OSA treatment; Procedure: Positive Airway Pressure Therapy

• Registration Number: NCT00518128
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-08-16
• Study First Submitted QC: 2007-08-16
• Study First Posted: 2007-08-20
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-18
• Last Update Posted: 2012-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Surgical OSA treatment	Surgical OSA Treatment Group: Moderate to Severe OSA patients who are unable to tolerate PAP (Positive Airway Pressure) and elect to proceed with surgical treatment (surgical cohort).
2	Positive Airway Pressure Therapy	Positive Airway Pressure Therapy Comparison Group: Moderate to Severe OSA patients who tolerate PAP (Positive Airway Pressure).

Primary Outcome Measures

Name	Time	Method
C-reactive protein level	Before and after surgery

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

UCSF Department of Otolaryngology - Head and Neck Surgery; 🇺🇸 San Francisco, California, United States