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Measuring Effectiveness in Sleep Apnea Surgery

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ClinicalTrials.gov Identifier: NCT00518128
Recruitment Status : Completed
First Posted : August 20, 2007
Last Update Posted : May 22, 2012
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Eric Kezirian, University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE August 16, 2007
First Posted Date  ICMJE August 20, 2007
Last Update Posted Date May 22, 2012
Study Start Date  ICMJE July 2007
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2007)
C-reactive protein level [ Time Frame: Before and after surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2007)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Measuring Effectiveness in Sleep Apnea Surgery
Official Title  ICMJE Measuring Effectiveness in Sleep Apnea Surgery
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obstructive Sleep Apnea
Intervention  ICMJE
  • Procedure: Surgical OSA treatment
    uvulopalatopharyngoplasty +/-tonsillectomy, genioglossus advancement, and hyoid suspension
    Other Name: UPPP, GA hyoid myotomy and suspension
  • Procedure: Positive Airway Pressure Therapy
    Continuous positive airway pressure for treatment of obstructive sleep apnea
    Other Name: CPAP
Study Arms  ICMJE
  • 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).
    Intervention: Procedure: Surgical OSA treatment
  • Active Comparator: 2
    Positive Airway Pressure Therapy Comparison Group: Moderate to Severe OSA patients who tolerate PAP (Positive Airway Pressure).
    Intervention: Procedure: Positive Airway Pressure Therapy
Publications * Kezirian EJ, Malhotra A, Goldberg AN, White DP. Changes in obstructive sleep apnea severity, biomarkers, and quality of life after multilevel surgery. Laryngoscope. 2010 Jul;120(7):1481-8. doi: 10.1002/lary.20946.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 19, 2012)
60
Original Estimated Enrollment  ICMJE
 (submitted: August 16, 2007)
120
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00518128
Other Study ID Numbers  ICMJE RR024130
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eric Kezirian, University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Eric Kezirian, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP