Measuring Effectiveness in Sleep Apnea Surgery

May 18, 2012 updated by: Eric Kezirian, University of California, San Francisco
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94115
        • UCSF Department of Otolaryngology - Head and Neck Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria (Surgical Group)

  • Unable to tolerate PAP, supported by statement from sleep physician
  • Multilevel airway obstruction
  • Elect to proceed with surgical OSA treatment (uvulopalatopharyngoplasty +/-tonsillectomy, genioglossus advancement, and hyoid suspension)

Inclusion Criteria (Comparison Group-PAP)

  • Tolerance of PAP during titration study and indication of willingness to use
  • No previous treatment of PAP except during titration study
  • Washout period of two weeks between PAP titration study and study assessment
  • Matched to surgical group patient on age, gender, race, body mass index, and OSA disease severity (apnea-hypopnea index)

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
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).
Procedure: Surgical OSA treatment
uvulopalatopharyngoplasty +/-tonsillectomy, genioglossus advancement, and hyoid suspension
Other Names:
  • UPPP, GA hyoid myotomy and suspension
Active Comparator: 2
Positive Airway Pressure Therapy Comparison Group: Moderate to Severe OSA patients who tolerate PAP (Positive Airway Pressure).
Procedure: Positive Airway Pressure Therapy
Continuous positive airway pressure for treatment of obstructive sleep apnea
Other Names:
  • CPAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
C-reactive protein level
Time Frame: Before and after surgery
Before and after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Leptin, Homocysteine, Homeostasis model of insulin resistance (HOMA-IR), Heart rate variability, Functional Outcomes of Sleep Questionnaire and Psychomotor Vigilance Task.
Time Frame: Before and after surgery
Before and after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Eric Kezirian, MD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

August 16, 2007

First Submitted That Met QC Criteria

August 16, 2007

First Posted (Estimate)

August 20, 2007

Study Record Updates

Last Update Posted (Estimate)

May 22, 2012

Last Update Submitted That Met QC Criteria

May 18, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RR024130

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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