Clinical trial NCT00518128: Measuring Effectiveness in Sleep Apnea Surgery
Official title: Measuring Effectiveness in Sleep Apnea Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive Sleep Apnea
Leptin
Homocysteine
C-reactive protein
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2007-08-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: C-reactive protein level
timeFrame: Before and after surgery
Secondary outcomes:
measure: Leptin, Homocysteine, Homeostasis model of insulin resistance (HOMA-IR), Heart rate variability, Functional Outcomes of Sleep Questionnaire and Psychomotor Vigilance Task.
timeFrame: Before and after surgery
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Department of Otolaryngology - Head and Neck Surgery
state: California
Study officials:
affiliation: University of California, San Francisco
name: Eric Kezirian, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.