Measuring Effectiveness in Sleep Apnea Surgery - Full Text View

Sponsor:	University of California, San Francisco
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00518128

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:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Measuring Effectiveness in Sleep Apnea Surgery

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea Surgery

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 ]

Estimated Enrollment:	120
Study Start Date:	July 2007
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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
2: Active Comparator 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

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

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

Contacts

Contact: Eric Kezirian, MD	415-353-2479	ekezirian@ohns.ucsf.edu
Contact: Wendy Ma	415-353-2870	wma@ohns.ucsf.edu

Locations

United States, California
UCSF Department of Otolaryngology - Head and Neck Surgery	Recruiting
San Francisco, California, United States, 94143
Principal Investigator: Eric Kezirian, MD

Sponsors and Collaborators

University of California, San Francisco

Investigators

Principal Investigator:

Eric Kezirian, MD

University of California, San Francisco

More Information

No publications provided

Responsible Party:	University of California, San Francisco ( Eric J. Kezirian, MD, MPH )
Study ID Numbers:	RR024130
Study First Received:	August 16, 2007
Last Updated:	March 16, 2009
ClinicalTrials.gov Identifier:	NCT00518128 History of Changes
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:

Signs and Symptoms
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Nervous System Diseases
Respiration Disorders

Sleep Apnea, Obstructive
Sleep Disorders
Dyssomnias
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on February 08, 2010