- Email: [email protected]
Combined radiofrequency surgery of tongue base and soft palate in obstructive sleep apnea
Scientific Session—Wednesday
sures. Correlations between baseline PSG indices and the other baseline measures ranged 0.004-0.24 (mean, 0.09), with one association significant of 40 tested (arousal index and SF-36 Mental Component Summary, r ⫽ 0.24, P ⫽ 0.03). Correlations between change in PSG indices and change in other outcome measures ranged 0.0001-0.39 (mean, 0.15), with two significant associations of 40 tested (apnea index and FOSQ, r ⫽ 0.30, P ⫽ 0.03; lowest saturation and SNORE25, r ⫽ 0.39, P ⫽ 0.005). Apnea-hypopnea index was not associated in any case. Conclusions: PSG indices are not consistently associated with sleepiness, QOL, or reaction time, both at baseline and as outcome measures. PSG indices may not quantify some important aspects of sleep apnea disease burden or treatment outcome. Clinically important outcomes should be measured directly.
9:38
AM
Popular Noninvasive Snoring Aids: Do They Work? Peter Michaelson MD (presenter); Eric A Mair MD San Antonio TX; San Antonio TX
Objectives: To critically evaluate three popular noninvasive treatments for snoring: an oral spray lubricant applied before bedtime, a nasal strip designed to maintain nasal valve patency, and a head-positioning pillow. Methods: Prospective, randomized clinical crossover trial of three popular noninvasive snore aids utilizing objective acoustic and spectral snoring analysis as well as subjective patient and bed-partner satisfaction questionnaires in over 40 known snoring patients. A combination digital recorder with acoustic and spectral analysis algorithms allowed respiratory disturbance screening and snoring analysis with data collected in the home environment. Results: Trends in preliminary analysis indicate limited objective benefit to the use of noninvasive snore aids. However, subjective results, especially for the oral spray, show some increase in patient and bed-partner satisfaction due to decreased snoring volume and duration as well as improved sleep quality and overall happiness. Overall, palatal vibrational snoring loudness decreased with the oral spray. No changes in respiratory disturbance index were noted with any of the three therapies. Complications included neck stiffness from the head-positioning pillow. Conclusions: This is the first prospective clinical comparison trial of popular noninvasive snoring aids. An oral spray lubricant snore sleep aid may offer improvement for those suffering from snoring and their bed-partners. However, objective data supporting this improvement are limited, and there seemed to be no significant objective or subjective improvement in the other modalities studied. Clinical significance: Outcome studies aid in verifying or refuting claims made by popular noninvasive snore aids.
9:46
AM
The Development of a Snoring Symptoms Inventory Susan Douglas FRCS Ed (presenter); Simon Webster; Mohamed Reda El Badawey FRCS; Michael Drinnan PhD; John Matthews PhD; John Gibson MD; Janet A Wilson MD FRCS Nottingham United Kingdom; Newcastle U Tyne United Kingdom; Newcastle U Tyne United Kingdom; Newcastle U Tyne United Kingdom; Newcastle U Tyne United Kingdom; Newcastle U Tyne United Kingdom; Newcastle U Tyne United Kingdom
Objectives: Snoring patients present to otolaryngologists with many physical and social complaints. The widely used Epworth Sleepiness Scale (ESS) is useful in the assessment of diurnal somnolence but does not address many other symptoms associated with snoring. Our aims were to develop a comprehensive, reliable, patient-derived symptom questionnaire for snoring, to determine its factor structure, and to determine its relationship to the ESS. Methods: The Snoring Symptoms Inventory (SSI) was developed by asking 120 habitual snorers to list all the problems they experienced due to snoring, in order of importance. The derived 25 items were each given a 5-point severity scale and used to compose the SSI. This study reports on a subsequent group of 261 patients (200 M and 61F; aged 25-69 years [mean, 43.6 years]) attending a snoring clinic between April 1998 and August 2002 who completed both the SSI and the ESS. Results: On a principal components analysis, 3 SSI factors (groups of questions) were identified: (1) direct effects of snoring (eg, disturbed sleep, feeling tired); (2) psychological aspects (eg, embarrassment when staying with friends); and (3) interpersonal problems (eg, family complaints about snoring). The first two factors had a significant correlation with the ESS (r ⫽ 0.42, P ⬍ 0.01 and r ⫽ 0.20, P ⬍ 0.01, respectively). The Cronbach’s alpha for the 25 questions was .81, demonstrating good reliability. Conclusions: The SSI is a comprehensive measure for assessing severity and outcomes. The factor that correlated best with the ESS was the direct effect of snoring. The psychological aspect of snoring was also well correlated with the ESS, and this may imply that snorers with greatest affective disturbance are also those who are diurnally somnolent. 10:00
AM
Combined Radiofrequency Surgery of Tongue Base and Soft Palate in Obstructive Sleep Apnea Boris A Stuck MD (presenter); Katrin Starzak; Gerhard Hein MD; Thomas Verse MD; Karl Hoermann MD; Joachim T Maurer MD Mannheim Germany; Mannheim Germany; Mannheim Germany; Mannheim Germany; Mannheim Germany; Mannheim Germany
Objectives: The combination of different surgical approaches has become a topic of increasing attention in the
WEDNESDAY
P200
Otolaryngology– Head and Neck Surgery August 2003
Otolaryngology– Head and Neck Surgery Volume 129 Number 2
10:08
AM
Anti-Snoring-Device: Short-Term Results of a New Minimally Invasive Surgical Technique Joachim T Maurer MD (presenter); Gerhard Hein MD; Thomas Verse MD; Boris A Stuck MD; Karl Hoermann MD Mannheim Germany; Mannheim Germany; Mannheim Germany; Mannheim Germany; Mannheim Germany
Objectives: As primary snoring is an innocuous but bothersome parasomnia, surgical treatment has to be as less invasive as possible. The aim of our study was to determine the safety and efficacy of a new soft palatal implant procedure for the reduction of palatal snoring. Methods: 15 healthy patients with primary snoring due to palatal flutter were enrolled into this prospective study after clinical and endoscopic examination and polysomnography (PSG) (41.2 ⫾ 8.6 years; body mass index, 26.2 ⫾ 2.5 kg/m2). The Anti-Snoring-Device is a cylindrical implant braided of polyester filaments. Under local anesthesia, three implants intended for permanent implantation were placed into the soft palate as close to the midline as possible. Snoring was assessed by visual analog scale (VAS), PSG, and the SNAP system before and 90 days after surgery.
Results: All implants could be placed without any complications. Only little discomfort was reported in some cases the first 3 days after the procedure. At the 90-day follow-up, snoring was reduced from 7.3 ⫾ 1.6 to 2.5 ⫾ 2.1 (VAS, P ⬍ 0.01) and from 347 ⫾ 239 to 264 ⫾ 168 snoring sounds/hour (SNAP, P ⬎ 0.05). PSG data as well as speech, swallowing, and taste remained unchanged. Conclusions: The Anti-Snoring-Device is a new surgical tool offering a simple and minimally invasive procedure. One advantage is that it does not sacrifice any tissue in order to achieve its purpose. Our subjective data demonstrate its safety and efficacy as well as good patients’ acceptance. Further studies are needed to obtain long-term results.
10:16
AM
A Comparison of Temperature-Controlled Radiofrequency Treatment Schemes for Sleep Apnea David L Steward MD (presenter); Edward M Weaver MD MPH; B Tucker Woodson MD Cincinnati OH; Seattle WA; Milwaukee WI
Objectives: Combined tongue and palate temperature-controlled radiofrequency tissue ablation (TCRFTA) has been shown to improve obstructive sleep apnea (OSA), specific quality of life, and reaction time in a randomized, shamcontrolled trial. We analyzed data from the active treatment group in the trial to test whether three tongue treatments provided as much improvement as five tongue and two palate. Methods: Thirty subjects were enrolled in the TCRFTA treatment group to receive five tongue and two palate treatments (three lesions per treatment). Outcomes were measured at baseline, 4 weeks following the third tongue treatment (interim), and 8 weeks following all tongue and palate treatments (final). Outcome measures included OSA-specific quality of life (FOSQ and SNORE25), daytime sleepiness (ESS), and reaction times (slowest, median, and fastest). Differences in outcomes were tested with the paired t test. Results: Twenty-nine subjects with mild to moderate OSA completed TCRFTA treatment (4.5 ⫾ 0.8 tongue and 1.5 ⫾ 0.7 palate treatments). Interim outcomes were significantly better than baseline for FOSQ, SNORE25, ESS, and fastest reaction time (all P ⬍ 0.05) but not for slowest reaction time and median reaction time. Final outcomes were significantly better than interim outcomes for FOSQ, ESS, slowest reaction time, and median reaction time (all P ⬍ 0.05) but not for SNORE25 and fastest reaction time. Conclusions: Three TCRFTA tongue treatments significantly improved OSA-specific quality of life, daytime sleepiness, and fastest reaction time for patients with mild to moderate OSA. An additional two TCRFTA tongue and palate treatments further significantly improved OSA-specific quality of life, daytime sleepiness, and slowest and median reaction time.
WEDNESDAY
management of sleep-disordered breathing. Temperaturecontrolled radiofrequency volumetric tissue reduction is a minimally invasive technique. The aim of this study was to investigate the safety and efficacy of a combined treatment of the tongue base and the soft palate in obstructive sleep apnea. Methods: 20 patients with obstructive sleep apnea (RDI ⱖ15) were enrolled in this prospective study. Temperaturecontrolled radiofrequency energy was repeatedly applied at the tongue base and at the soft palate under local anesthesia. Postoperative morbidity and functional parameters were assessed using questionnaires (Visual Analogue Scales [VAS]; Epworth Sleepiness Scale [ESS]). Fully attended polysomnography was used for two consecutive nights both before and after treatment in order to evaluate efficacy. Results: 18 out of 20 patients completed the study. Complications did not occur. Mean pain scores dropped from 5.6 ⫾ 2.6 at day one to 0.6 ⫾ 1.1 at day seven. Painkillers were taken for 3.3 ⫾ 2.3 days. Daytime sleepiness (ESS) improved from 9.1 ⫾ 4.4 to 6.0 ⫾ 4.2, and snoring scores (VAS) dropped from 7.5 ⫾ 2.1 to 3.5 ⫾ 3.0 (P ⬍ 0.05). Functional parameters did not change. The mean respiratory disturbance index was significantly reduced from 25.3 ⫾ 11.4 to 16.7 ⫾ 15.3 (P ⬍ 0.05). Mean oxygen saturation improved significantly (P ⫽ 0.05). After 2.7 treatment sessions, 7 patients were cured (RDI ⬍15 plus a reduction of ⬎50%) and 12 patients responded in total. Conclusions: Combined radiofrequency volumetric tissue reduction of the tongue base and the soft palate is safe and effective in the treatment of mild to moderate obstructive sleep apnea.
Scientific Session—Wednesday P201
sures. Correlations between baseline PSG indices and the other baseline measures ranged 0.004-0.24 (mean, 0.09), with one association significant of 40 tested (arousal index and SF-36 Mental Component Summary, r ⫽ 0.24, P ⫽ 0.03). Correlations between change in PSG indices and change in other outcome measures ranged 0.0001-0.39 (mean, 0.15), with two significant associations of 40 tested (apnea index and FOSQ, r ⫽ 0.30, P ⫽ 0.03; lowest saturation and SNORE25, r ⫽ 0.39, P ⫽ 0.005). Apnea-hypopnea index was not associated in any case. Conclusions: PSG indices are not consistently associated with sleepiness, QOL, or reaction time, both at baseline and as outcome measures. PSG indices may not quantify some important aspects of sleep apnea disease burden or treatment outcome. Clinically important outcomes should be measured directly.
9:38
AM
Popular Noninvasive Snoring Aids: Do They Work? Peter Michaelson MD (presenter); Eric A Mair MD San Antonio TX; San Antonio TX
Objectives: To critically evaluate three popular noninvasive treatments for snoring: an oral spray lubricant applied before bedtime, a nasal strip designed to maintain nasal valve patency, and a head-positioning pillow. Methods: Prospective, randomized clinical crossover trial of three popular noninvasive snore aids utilizing objective acoustic and spectral snoring analysis as well as subjective patient and bed-partner satisfaction questionnaires in over 40 known snoring patients. A combination digital recorder with acoustic and spectral analysis algorithms allowed respiratory disturbance screening and snoring analysis with data collected in the home environment. Results: Trends in preliminary analysis indicate limited objective benefit to the use of noninvasive snore aids. However, subjective results, especially for the oral spray, show some increase in patient and bed-partner satisfaction due to decreased snoring volume and duration as well as improved sleep quality and overall happiness. Overall, palatal vibrational snoring loudness decreased with the oral spray. No changes in respiratory disturbance index were noted with any of the three therapies. Complications included neck stiffness from the head-positioning pillow. Conclusions: This is the first prospective clinical comparison trial of popular noninvasive snoring aids. An oral spray lubricant snore sleep aid may offer improvement for those suffering from snoring and their bed-partners. However, objective data supporting this improvement are limited, and there seemed to be no significant objective or subjective improvement in the other modalities studied. Clinical significance: Outcome studies aid in verifying or refuting claims made by popular noninvasive snore aids.
9:46
AM
The Development of a Snoring Symptoms Inventory Susan Douglas FRCS Ed (presenter); Simon Webster; Mohamed Reda El Badawey FRCS; Michael Drinnan PhD; John Matthews PhD; John Gibson MD; Janet A Wilson MD FRCS Nottingham United Kingdom; Newcastle U Tyne United Kingdom; Newcastle U Tyne United Kingdom; Newcastle U Tyne United Kingdom; Newcastle U Tyne United Kingdom; Newcastle U Tyne United Kingdom; Newcastle U Tyne United Kingdom
Objectives: Snoring patients present to otolaryngologists with many physical and social complaints. The widely used Epworth Sleepiness Scale (ESS) is useful in the assessment of diurnal somnolence but does not address many other symptoms associated with snoring. Our aims were to develop a comprehensive, reliable, patient-derived symptom questionnaire for snoring, to determine its factor structure, and to determine its relationship to the ESS. Methods: The Snoring Symptoms Inventory (SSI) was developed by asking 120 habitual snorers to list all the problems they experienced due to snoring, in order of importance. The derived 25 items were each given a 5-point severity scale and used to compose the SSI. This study reports on a subsequent group of 261 patients (200 M and 61F; aged 25-69 years [mean, 43.6 years]) attending a snoring clinic between April 1998 and August 2002 who completed both the SSI and the ESS. Results: On a principal components analysis, 3 SSI factors (groups of questions) were identified: (1) direct effects of snoring (eg, disturbed sleep, feeling tired); (2) psychological aspects (eg, embarrassment when staying with friends); and (3) interpersonal problems (eg, family complaints about snoring). The first two factors had a significant correlation with the ESS (r ⫽ 0.42, P ⬍ 0.01 and r ⫽ 0.20, P ⬍ 0.01, respectively). The Cronbach’s alpha for the 25 questions was .81, demonstrating good reliability. Conclusions: The SSI is a comprehensive measure for assessing severity and outcomes. The factor that correlated best with the ESS was the direct effect of snoring. The psychological aspect of snoring was also well correlated with the ESS, and this may imply that snorers with greatest affective disturbance are also those who are diurnally somnolent. 10:00
AM
Combined Radiofrequency Surgery of Tongue Base and Soft Palate in Obstructive Sleep Apnea Boris A Stuck MD (presenter); Katrin Starzak; Gerhard Hein MD; Thomas Verse MD; Karl Hoermann MD; Joachim T Maurer MD Mannheim Germany; Mannheim Germany; Mannheim Germany; Mannheim Germany; Mannheim Germany; Mannheim Germany
Objectives: The combination of different surgical approaches has become a topic of increasing attention in the
WEDNESDAY
P200
Otolaryngology– Head and Neck Surgery August 2003
Otolaryngology– Head and Neck Surgery Volume 129 Number 2
10:08
AM
Anti-Snoring-Device: Short-Term Results of a New Minimally Invasive Surgical Technique Joachim T Maurer MD (presenter); Gerhard Hein MD; Thomas Verse MD; Boris A Stuck MD; Karl Hoermann MD Mannheim Germany; Mannheim Germany; Mannheim Germany; Mannheim Germany; Mannheim Germany
Objectives: As primary snoring is an innocuous but bothersome parasomnia, surgical treatment has to be as less invasive as possible. The aim of our study was to determine the safety and efficacy of a new soft palatal implant procedure for the reduction of palatal snoring. Methods: 15 healthy patients with primary snoring due to palatal flutter were enrolled into this prospective study after clinical and endoscopic examination and polysomnography (PSG) (41.2 ⫾ 8.6 years; body mass index, 26.2 ⫾ 2.5 kg/m2). The Anti-Snoring-Device is a cylindrical implant braided of polyester filaments. Under local anesthesia, three implants intended for permanent implantation were placed into the soft palate as close to the midline as possible. Snoring was assessed by visual analog scale (VAS), PSG, and the SNAP system before and 90 days after surgery.
Results: All implants could be placed without any complications. Only little discomfort was reported in some cases the first 3 days after the procedure. At the 90-day follow-up, snoring was reduced from 7.3 ⫾ 1.6 to 2.5 ⫾ 2.1 (VAS, P ⬍ 0.01) and from 347 ⫾ 239 to 264 ⫾ 168 snoring sounds/hour (SNAP, P ⬎ 0.05). PSG data as well as speech, swallowing, and taste remained unchanged. Conclusions: The Anti-Snoring-Device is a new surgical tool offering a simple and minimally invasive procedure. One advantage is that it does not sacrifice any tissue in order to achieve its purpose. Our subjective data demonstrate its safety and efficacy as well as good patients’ acceptance. Further studies are needed to obtain long-term results.
10:16
AM
A Comparison of Temperature-Controlled Radiofrequency Treatment Schemes for Sleep Apnea David L Steward MD (presenter); Edward M Weaver MD MPH; B Tucker Woodson MD Cincinnati OH; Seattle WA; Milwaukee WI
Objectives: Combined tongue and palate temperature-controlled radiofrequency tissue ablation (TCRFTA) has been shown to improve obstructive sleep apnea (OSA), specific quality of life, and reaction time in a randomized, shamcontrolled trial. We analyzed data from the active treatment group in the trial to test whether three tongue treatments provided as much improvement as five tongue and two palate. Methods: Thirty subjects were enrolled in the TCRFTA treatment group to receive five tongue and two palate treatments (three lesions per treatment). Outcomes were measured at baseline, 4 weeks following the third tongue treatment (interim), and 8 weeks following all tongue and palate treatments (final). Outcome measures included OSA-specific quality of life (FOSQ and SNORE25), daytime sleepiness (ESS), and reaction times (slowest, median, and fastest). Differences in outcomes were tested with the paired t test. Results: Twenty-nine subjects with mild to moderate OSA completed TCRFTA treatment (4.5 ⫾ 0.8 tongue and 1.5 ⫾ 0.7 palate treatments). Interim outcomes were significantly better than baseline for FOSQ, SNORE25, ESS, and fastest reaction time (all P ⬍ 0.05) but not for slowest reaction time and median reaction time. Final outcomes were significantly better than interim outcomes for FOSQ, ESS, slowest reaction time, and median reaction time (all P ⬍ 0.05) but not for SNORE25 and fastest reaction time. Conclusions: Three TCRFTA tongue treatments significantly improved OSA-specific quality of life, daytime sleepiness, and fastest reaction time for patients with mild to moderate OSA. An additional two TCRFTA tongue and palate treatments further significantly improved OSA-specific quality of life, daytime sleepiness, and slowest and median reaction time.
WEDNESDAY
management of sleep-disordered breathing. Temperaturecontrolled radiofrequency volumetric tissue reduction is a minimally invasive technique. The aim of this study was to investigate the safety and efficacy of a combined treatment of the tongue base and the soft palate in obstructive sleep apnea. Methods: 20 patients with obstructive sleep apnea (RDI ⱖ15) were enrolled in this prospective study. Temperaturecontrolled radiofrequency energy was repeatedly applied at the tongue base and at the soft palate under local anesthesia. Postoperative morbidity and functional parameters were assessed using questionnaires (Visual Analogue Scales [VAS]; Epworth Sleepiness Scale [ESS]). Fully attended polysomnography was used for two consecutive nights both before and after treatment in order to evaluate efficacy. Results: 18 out of 20 patients completed the study. Complications did not occur. Mean pain scores dropped from 5.6 ⫾ 2.6 at day one to 0.6 ⫾ 1.1 at day seven. Painkillers were taken for 3.3 ⫾ 2.3 days. Daytime sleepiness (ESS) improved from 9.1 ⫾ 4.4 to 6.0 ⫾ 4.2, and snoring scores (VAS) dropped from 7.5 ⫾ 2.1 to 3.5 ⫾ 3.0 (P ⬍ 0.05). Functional parameters did not change. The mean respiratory disturbance index was significantly reduced from 25.3 ⫾ 11.4 to 16.7 ⫾ 15.3 (P ⬍ 0.05). Mean oxygen saturation improved significantly (P ⫽ 0.05). After 2.7 treatment sessions, 7 patients were cured (RDI ⬍15 plus a reduction of ⬎50%) and 12 patients responded in total. Conclusions: Combined radiofrequency volumetric tissue reduction of the tongue base and the soft palate is safe and effective in the treatment of mild to moderate obstructive sleep apnea.
Scientific Session—Wednesday P201