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Measuring Effectiveness in Sleep Apnea Surgery
This study has been completed.
Sponsor:
University of California, San Francisco
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
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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 Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Measuring Effectiveness in Sleep Apnea Surgery |
Resource links provided by NLM:
Further study details as provided by Eric Kezirian, University of California, San Francisco:
Primary Outcome Measures:
- C-reactive protein level [ Time Frame: Before and after surgery ]
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 ]
| 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 (Adult, Senior) |
| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00518128
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
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 |
Keywords provided by Eric Kezirian, University of California, San Francisco:
|
Obstructive Sleep Apnea Leptin Homocysteine C-reactive protein |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on June 23, 2017