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Measuring Effectiveness in Sleep Apnea Surgery

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Eric Kezirian, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00518128
First received: August 16, 2007
Last updated: May 18, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention
Obstructive Sleep Apnea
 Procedure: Surgical OSA treatment
Procedure: Positive Airway Pressure Therapy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Measuring Effectiveness in Sleep Apnea Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • C-reactive protein level [ Time Frame: Before and after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
Enrollment: 60
Study Start Date: July 2007
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00518128

Locations
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
Principal Investigator: Eric Kezirian, MD University of California, San Francisco
  More Information

No publications provided by University of California, San Francisco

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Eric Kezirian, Associate Professor, Department of Otolaryngology--Head and Neck Surgery, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00518128     History of Changes
Other Study ID Numbers: RR024130
Study First Received: August 16, 2007
Last Updated: May 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Obstructive Sleep Apnea
Leptin
Homocysteine
C-reactive protein

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Dyssomnias
Nervous System Diseases
Respiration Disorders
 Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on February 27, 2015