Measuring Effectiveness in Sleep Apnea Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Measuring Effectiveness in Sleep Apnea Surgery

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Procedure: Surgical OSA treatment
* Procedure: Positive Airway Pressure Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>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<br>* uvulopalatopharyngoplasty +/-tonsillectomy, genioglossus advancement, and hyoid suspension<br>* Other names: UPPP, GA hyoid myotomy and suspension;|
| Active Comparator: 2<br>Positive Airway Pressure Therapy Comparison Group: Moderate to Severe OSA patients who tolerate PAP (Positive Airway Pressure). | Procedure: Positive Airway Pressure Therapy<br>* Continuous positive airway pressure for treatment of obstructive sleep apnea<br>* Other names: CPAP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-reactive protein level |  | Before and after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leptin, Homocysteine, Homeostasis model of insulin resistance (HOMA-IR), Heart rate variability, Functional Outcomes of Sleep Questionnaire and Psychomotor Vigilance Task. |  | Before and after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obstructive Sleep Apnea, Leptin, Homocysteine, C-reactive protein