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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Procedure: Surgical OSA treatment Procedure: Positive Airway Pressure Therapy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Measuring Effectiveness in Sleep Apnea Surgery
Study Start Date : July 2007
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arms and Interventions
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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 Name: 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 Name: CPAP


Outcome Measures
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Primary Outcome Measures :
  1. C-reactive protein level [ Time Frame: Before and after surgery ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00518128


Locations
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United States, California
UCSF Department of Otolaryngology - Head and Neck Surgery
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Eric Kezirian, MD University of California, San Francisco
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Eric Kezirian, Associate Professor, Department of Otolaryngology--Head and Neck Surgery, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00518128    
Other Study ID Numbers: RR024130
First Posted: August 20, 2007    Key Record Dates
Last Update Posted: May 22, 2012
Last Verified: May 2012
Keywords provided by Eric Kezirian, University of California, San Francisco:
Obstructive Sleep Apnea
Leptin
Homocysteine
C-reactive protein
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases