Obstructive Sleep Apnea
Conditions
Keywords
Obstructive Sleep Apnea, Leptin, Homocysteine, C-reactive protein
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.
Interventions
PROCEDURESurgical OSA treatment
uvulopalatopharyngoplasty +/-tonsillectomy, genioglossus advancement, and hyoid suspension
PROCEDUREPositive Airway Pressure Therapy
Continuous positive airway pressure for treatment of obstructive sleep apnea
Sponsors
National Institutes of Health (NIH)
University of California, San Francisco
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| C-reactive protein level | Before and after surgery |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed