Measuring Effectiveness in Sleep Apnea Surgery

NCT ID: NCT00518128

Last Updated: 2012-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2011-06-30

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Surgical OSA treatment

Intervention Type: PROCEDURE

uvulopalatopharyngoplasty +/-tonsillectomy, genioglossus advancement, and hyoid suspension

2

Positive Airway Pressure Therapy Comparison Group: Moderate to Severe OSA patients who tolerate PAP (Positive Airway Pressure).

Group Type: ACTIVE_COMPARATOR

Positive Airway Pressure Therapy

Intervention Type: PROCEDURE

Continuous positive airway pressure for treatment of obstructive sleep apnea

Interventions

Surgical OSA treatment

uvulopalatopharyngoplasty +/-tonsillectomy, genioglossus advancement, and hyoid suspension

Intervention Type: PROCEDURE

Positive Airway Pressure Therapy

Continuous positive airway pressure for treatment of obstructive sleep apnea

Intervention Type: PROCEDURE

Other Intervention Names

UPPP, GA hyoid myotomy and suspension; CPAP

Eligibility Criteria

Inclusion Criteria

• 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)

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Eric Kezirian

Associate Professor, Department of Otolaryngology--Head and Neck Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric Kezirian, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

UCSF Department of Otolaryngology - Head and Neck Surgery

San Francisco, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 20564750 (View on PubMed)

Other Identifiers

RR024130

Identifier Type: -

Identifier Source: org_study_id