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The SLEEP STUDY: Studying Life Effects and Effectiveness of Palatopharyngoplasty
Co-Principal Investigators: Edward M. Weaver, MD, MPH; B. Tucker Woodson, MD Steering Committee Members: Michael G Stewart MD, MPH; David Witsell, MD, MHS; Maureen Hannley, PhD; Timothy Smith, MD, MPH; Bevan Yueh, MD, MPH This is a prospective longitudinal cohort study designed to evaluate the effectiveness of uvulopalatopharyngoplasty (UPPP) to improve sleep apnea specific quality of life. This study will also test predictors of good surgical outcomes. This study is ongoing at multiple clinic sites, with Duke University serving as the data coordinating center and administering follow-up. The University of Washington, Seattle is one clinical site with Edward M. Weaver, MD, MPH and Nicole Maronian, MD participating in patient enrollment.
Introduction: Specific Aims:
Hypotheses: Secondary Hypotheses: More Information about Friedman's Staging Check out more information on the SLEEP study at the Academy of Otolaryngology-Head and Neck Surgery website
Incidence of Serious Complications after Uvulopalatopharyngoplasty
Co-Principal Investigators: Eric J. Kezirian, MD, MPH and Edward M. Weaver, MD, MPH Co-Investigators: Bevan Yueh, MD, MPH; Richard A. Deyo, MD, MPH; Shukri F. Khuri, MD; Jennifer Daley, MD; William Henderson, PhD Laryngoscope 114:450-53, March 2004 The primary objective of this study was to calculate the incidence of perioperative complications in a large, multisite cohort of patients undergoing uvulopalatopharyngolplasty (UPPP). This prospective cohort study utilized the Department of Veterans Affairs National Surgical Quality Improvement Program (NSQIP) database for the years 1991-2001. NSQIP collects 30-day complication and mortality data on all inpatient surgeries performed at VA medical centers in the United States. Patients undergoing inpatient UPPP with or without other concurrent procedures were included in the analysis. Serious complications were defined by 15 specific life-threatening complications and deaths were captured whether the patient was in the hospital or discharged. Serious complications included reintubation, pneumonia, prolonged ventilation, emergent tracheotomy, pulmonary edema, cardiac arrest, myocardial infarction, cerebrovascular accident, hemorrhage, wound infection, and sepsis among others. Results: The cohort included 3130 veteran patients (97% male) with a mean age of 50 years. Forty-seven patients experienced serious nonfatal complications for a rate of 1.5% (95% CI of 1.1%, 1.9%). The 30-day mortality rate was 0.2% (95% CI 0.1%, 0.4%). Conclusion: Among a large cohort of UPPP patients at veteran hospitals, the incidence of serious nonfatal complications and 30-day mortality after UPPP are 1.5% and 0.2%, respectively. Article: Incidence of Serious Complications After Uvulopalatopharyngoplasty
Survival of Veterans with Sleep Apnea: Continuous Positive Airway Pressure versus Surgery
Principal Investigator: Edward M. Weaver, MD, MPH Co-Investigators: Charles Maynard, PhD; Bevan Yueh, MD, MPH Otolaryngology—Head & Neck Surgery 130(6): 659-665, June 2004 While previous research has established that continuous positive airway pressure (CPAP) improves sleep apnea survival, this study was designed to test whether CPAP therapy is associated with better survival than uvulopalatopharyngoplasty (UPPP). This retrospective cohort study utilized a database which included all sleep apnea patients treated with CPAP or UPPP in Veterans Affairs facilities from October 1997 through September 2001. Patients treated for sleep apnea within this time period were identified from ICD-9 diagnostic and procedure codes. The two treatment groups were compared with Cox regression, adjusting for age, gender, race, year treatment was initiated, and comorbidity. Results: By September 2002, 1339 (7.1%) of 18,754 CPAP patients and 71 (3.4%) of 2,072 UPPP patients were deceased (p<0.001). After adjustment, CPAP patients had 31% higher probability of being dead at any time, relative to UPPP patients (95% CI: 3% to 67%, p = 0.03). Conclusion: UPPP confers a survival advantage over CPAP after adjustment for age, gender, race, year of treatment and comorbidity. However, sleep apnea severity and CPAP use data were not available. Article: Survival of Veterans with Sleep Apnea: Continuous Positive Airway Pressure versus Surgery
Mortality of Veterans with Sleep Apnea: Untreated versus Treated
Principal Investigator: Edward M. Weaver, MD, MPH Co-Investigators: Charles Maynard, PhD; Bevan Yueh, MD, MPH SLEEP, Volume 27, Abstract Supplement, 2004 While leaving obstructive sleep apnea (OSA) untreated appears to increase mortality, the effect of treatment on mortality is unclear because previous reports have analyzed small samples and not adequately controlled for comorbidity. The purpose of this research was to determine whether providing a continuous positive airway pressure (CPAP) device or performing uvulopalatopharyngoplasty (UPPP) is associated with a decreased mortality rate relative to providing no treatment for OSA. This analysis was performed on large cohort with control for comorbidity. This retrospective inception cohort study included all patients diagnosed with OSA in Veteran’s Affairs inpatient facility 1991-2001 or outpatient facility 1997-2001. Subjects were identified by ICD-9 diagnostic codes. Treatment status was grouped into CPAP, UPPP, and tracheotomy. If the patient did not have one of these codes, they were considered untreated. Results: By September 2002, 16,967 of 116,678 untreated patients, 3256 of 28612 CPAP patients, and 394 of 3977 UPPP patients were dead (untreated vs. treated, p<0.001). From the date of OSA diagnosis, untreated patients survived 3.6+/-2.3 (mean+/-SD), CPAP patients survived 4.6+/-2.5 years, and UPPP patients survived 5.3+/-2.5 years (untreated vs treated, p<0.001). After adjusting for age, sex, race, comorbidity and inception year, untreated patients had 1.9 (95% CI 1.8-2.0, p<0.001) times greater hazard of dying at any time relative to treated patients. UPPP patients had a lesser mortality rate (p=0.006), longer survival (p<0.001), and lesser hazard of death (adjusted HR =0.57. 95% CI 0.39-0.81, p=0.002) relative to CPAP patients. Conclusion: Treatment of sleep apnea, with CPAP or UPPP confers a survival advantage over no treatment, after adjusting for age, sex, race, comorbidity, and year of OSA diagnosis. However, because CPAP usage data were not available, conclusions about the relative efficacy of CPAP and UPPP cannot be drawn. Article: Mortality of Veterans with Sleep Apnea: Untreated versus Treated
A Randomized Trial of Temperature-controlled Radiofrequency, Continuous Positive Airway Pressure, and Placebo for Obstructive Sleep Apnea Syndrome
Principal Investigator: B. Tucker Woodson, MD Co-Investigators: David L. Steward, MD; Edward M. Weaver, MD, MPH; Shahrokh Javaheri, MD Otolaryngology- Head and Neck Surgery 128 (6):848-861, June, 2003 The goal of this research was to determine the effectiveness of temperature-controlled radiofrequency tissue ablation (TCRFTA) and continuous positive airway pressure (CPAP) for the treatment of mild to moderate obstructive sleep apnea. This was a randomized, placebo-controlled, 2-site trial with thirty patients receiving TCRFTA (at tongue base and palate), thirty receiving CPAP and thirty undergoing sham-placebo TCRFTA treatment. The primary outcome measures assessed were changes in slowest reaction time (from psychomotor vigilance testing) and quality of life measures from the Obstructive Sleep Apnea Syndrome-specific questionnaire. Results: Compared to pretreatment baseline, TCRFTA improved reaction time, OSAS-specific quality life, subjective sleepiness (p-values <0.05). Compared to sham-placebo, TCRFTA improved QOL, airway volume, apnea index and respiratory arousal index (p-values <0.05). TCRFTA side effects and complications were mild, temporary and similar to sham-placebo. CPAP improved QOL and sleepiness compared with baseline and QOL when compared to sham-placebo (p-values <0.05). Conclusions: TCRFTA and CPAP each improve QOL for patients with mild to moderate obstructive sleep apnea. CPAP continues to be the primary therapeutic option as it poses no risk and CPAP users achieve good outcomes. TCRFTA may represent an alternative treatment for patients who refuse CPAP, demonstrate inadequate use, or experience insufficient improvement of symptoms.
A Comparison of Radiofrequency Treatment Schemes for Obstructive Sleep Apnea Syndrome
Principal Investigators: David L. Steward, MD Co-Investigators: Edward M. Weaver, MD, MPH; B. Tucker Woodson, MD Otolaryngology- Head and Neck Surgery 130 (5): 579-585, May, 2004 The purpose of this study was to determine if increasing the number of temperature-controlled radiofrequency tissue ablation (TCRFTA) treatments provided incremental improvement in outcomes of obstructive sleep apnea syndrome (OSAS). Twenty-six subjects receiving TCRFTA treatment for mild to moderate OSAS were studied at baseline, 1 month after 3 tongue treatments (interim) and then 2 months after 2 additional tongue and palate treatments (final). Outcomes considered were OSA-specific quality of life (Functional Outcomes of Sleep Questionnaire (FOSQ)) and Symptoms of Nocturnal Obstruction and Related Events (SNORE25), daytime sleepiness, and reaction times. Results: Outcomes at interim time points were significantly better than baseline for FOSQ and SNORE25 (p-values < 0.05). A trend toward improvement in sleepiness was evident (p=0.06). Outcomes after two additional tongue and palate treatments (final) were significantly better than interim outcomes for FOSQ, sleepiness, and slowest and median reaction time (all p-values <0.05). Final outcomes were non-significantly improved for SNORE25 (p=0.30) and fastest reaction time (p=0.18). All final outcomes were improved from baseline (p=values <0.05). Conclusions: Three TCRFTA tongue treatments significantly improved OSA-specific quality of life. An additional two treatments to the tongue and palate, further significantly improved quality of life and reaction times. Article: A Comparison of Radiofrequency Treatment Schemes for Obstructive Sleep Apnea Syndrome
Multilevel Temperature-controlled Radiofrequency for Obstructive Sleep Apnea: Extended follow-up
Principal Investigators: David L. Steward, MD Co-Investigators: Edward M. Weaver, MD, MPH; B. Tucker Woodson, MD Otolaryngology- Head and Neck Surgery 132 (4): 630-635, April 2005 The aim of this research is to determine the long-term effectiveness of multilevel (tongue and palate) temperature-controlled radio frequency ablation (TCRFTA) among patients with obstructive sleep apnea syndrome (OSAS). This was a prospective case series involving two institutions. Twenty-nine subjects with mild to moderate OSAS who were at least one year from completion of multilevel TCRFTA were included. None of these subjects received any additional treatment for their sleep apnea after completion of TCRFTA. Results: Median reaction time testing and apnea-hypopnea index (AHI) were significantly improved at long-term follow-up (p= 0.03), (p= 0.01). Both daytime sleepiness and OSAS-related quality of life were improved as well (p<0.001). The median follow-up time for these subjects was 23 months. Body mass index was unchanged (p=0.94). Conclusions: These results suggest that multilevel TCRFTA results in prolonged subjective and objective improvements across treatment outcomes including daytime somnolence, OSAS-related quality of life, psychomotor vigilance, and AHI. Article: Multilevel Temperature-Controlled Radiofrequency for Obstructive Sleep Apnea: Extended Follow-up
An Adjunctive Method of Radiofrequency Volumetric Tissue Reduction of the Tongue for OSAS
Principal Investigator: Robert W. Riley MD, DDS Co-Investigators: Nelson B. Powell, MD; Kasey K. Li, MD, DDS; Edward M. Weaver, MD, MPH; Christian Guilleminault, MD Otolaryngology- Head and Neck Surgery 129 (1): 37-42, July 2003 Temperature-controlled radiofrequency volumetric reduction (TCRF) has been used to treat tongue based obstruction in Obstructive Sleep Apnea Syndrome (OSAS). This study was designed to evaluate an adjunctive application to the ventral tongue in addition to the traditional dorsal-only application.
This was a prospective, nonrandomized clinical study consisting of 20 consecutive OSAS patients with isolated tongue base obstruction. Treatment was applied to both the ventral (genioglossus insertion) and dorsal tongue (link to Figure 1). Changes in speech and swallowing were assessed using a visual analog scale. Polysomnography and the Epworth Sleepiness Scale (ESS) were used to assess outcome. Patients continued their use of nasal continuous positive airway pressure after each treatment. Results: Patients underwent a mean of 4.6 treatments with a mean of 1741 ± 1152 joules delivered per treatment. No significant changes were noted in speech or swallowing at three months after completion of treatment. Patients reported significant decrease in sleepiness with a mean change in ESS from 12.4 ± 2.9 to 7.3 ± 3.0 (p<0.001). The mean apnea/hypopnea index decreased from 35.1 ± 18.1 to 15.1 ± 17.47 (p<0.001). Transient pain and swelling occurred after each treatment but there were no complications. Conclusion: This study demonstrates that TCRF tongue reduction reduces the severity of OSA. Combined treatment of the ventral and dorsal tongue appears safe and may improve outcome with less total energy when compared to traditional dorsal-only applications. Article: An Adjunctive Method of Radiofrequency Volumetric Tissue Reduction of the Tongue for OSAS
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