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Objectives It is generally assumed that mouth opening decreases the hypopharyngeal cross-sectional area (HA) and that tongue protrusion (TP) increases the HA. We hypothesize that a substantial number of patients do not exhibit this expected pattern. Study Design Prospective cohort conducted at a tertiary academic center. Methods With a flexible fiberoptic scope in position, the hypopharyngeal airway was visualized and assessed in 189 patients with the mouth closed. Patients were then asked to open the mouth with the tongue in neutral position (MOTN) to determine the effect on the airway. The same methodology was used to compare the airway with the MOTN versus TP. Basic demographics, including age, gender, body mass index, and presence and severity of obstructive sleep apnea (OSA), were collected. Student t test, Mantel-Haenszel chi-square, and Cochran-Armitage analyses were assessed for significant relationships and trends with oral positions. Results Although mean HA decreased with MOTN (P < 0.0001), 33% of patients exhibited an increase in HA. Similarly, mean HA increased with TP (P = 0.0018); however, 38% of patients demonstrated a decrease in HA. There was no significant relationship in HA between OSA and non-OSA patients. For those with OSA, increasing severity trended toward a higher incidence of smaller HA with TP (P = 0.038). Conclusion The airway is typically most obstructed with mouth opening (MOTN) and most patent with tongue protrusion (TP). Nevertheless, hypopharyngeal changes with MOTN and TP followed a paradoxical pattern in one-third of our population. This may have implications in patient selection for targeted OSA treatment. Level of Evidence IV. Laryngoscope, 2016

Objectives/Hypothesis This feasibility study was designed to show the preliminary safety and efficacy of targeted hypoglossal neurostimulation (THN), and to identify baseline predictors of successful therapy. Study Design Open-label, prospective, multicenter, single-arm cohort study, conducted at seven centers in the U.S.A. and Europe. Methods Forty-six participants with moderate to severe obstructive sleep apnea (OSA), failing or intolerant of continuous positive airway pressure, were implanted. Primary (Apnea-Hypopnea Index [AHI], Oxygen Desaturation Index [ODI]) and secondary (Arousal Index, Epworth Sleepiness Scale Index, Sleep Apnea Quality of Life Index) outcomes were measured at baseline and compared at 6 months. Data were analyzed to identify participant characteristics that would predict success with therapy. Results Sixty-seven adverse events (AEs) were observed among 36 participants; most of the AEs were related to the implant procedure and resolved without sequelae; one device replacement was necessary. Forty-three participants showed significant (P 10%. Seven participants met these criteria; 86% (6 of 7) were AHI responders and 86% (6 of 7) were ODI responders, indicating that THN therapy can be efficacious in a carefully selected population of OSA patients. Conclusions This feasibility study suggests that THN therapy is likely to be safe and effective in selected patients. Level of Evidence 2b Laryngoscope, 126:2618–2623, 2016

Objectives/Hypothesis Determine the impact of nasal obstruction on efficacy, success, and adherence of Provent therapy in patients with obstructive sleep apnea (OSA). Study Design Prospective, two-arm, clinical pilot study at a single clinical site. Methods Patients with OSA who failed continuous positive airway pressure therapy were divided into two treatment arms: arm 1 were patients with no complaints of nasal obstruction and

Objectives/Hypothesis To identify standard clinical parameters that may predict the optimal level of continuous positive airway pressure (CPAP) in adult patients with obstructive sleep apnea/hypopnea syndrome (OSAHS). Study Design This is a retrospective study in a tertiary academic medical center that included 129 adult patients (117 males and 12 females) with OSAHS confirmed by diagnostic polysomnography (PSG). Methods All OSAHS patients underwent successful full-night manual titration to determine the optimal CPAP pressure level for OSAHS treatment. The PSG parameters and completed physical examination, including body mass index, tonsil size grading, modified Mallampati grade (also known as updated Friedman's tongue position [uFTP]), uvular length, neck circumference, waist circumference, hip circumference, thyroid-mental distance, and hyoid-mental distance (HMD) were recorded. Results When the physical examination variables and OSAHS disease were correlated singly with the optimal CPAP pressure, we found that uFTP, HMD, and apnea/hypopnea index (AHI) were reliable predictors of CPAP pressures (P = .013, P = .002, and P < .001, respectively, by multiple regression). When all important factors were considered in a stepwise multiple linear regression analysis, a significant correlation with optimal CPAP pressure was formulated by factoring the uFTP, HMD, and AHI (optimal CPAP pressure = 1.01 uFTP + 0.74 HMD + 0.059 AHI − 1.603). Conclusions This study distinguished the correlation between uFTP, HMD, and AHI with the optimal CPAP pressure. The structure of the upper airway (especially tongue base obstruction) and disease severity may predict the effective level of CPAP pressure. Level of Evidence 4. Laryngoscope, 125:1983–1987, 2015

Objectives/Hypothesis To determine the effect of treatment of obstructive sleep apnea (OSA) with custom-made mandibular advancement devices (MADs) on C-reactive protein (CRP) levels in patients with obstructive sleep apnea/hypopnea syndrome (OSAHS). Study Design Case series with chart review. Methods Charts of consecutive patients fitted with custom-made mandibular advancement devices for treatment of OSAHS between December 2011 and November 2012 were reviewed. Demographics such as age, sex, and body mass index (BMI) were collected. Prefitting and postfitting polysomnograms were reviewed. Pre- and posttreatment apnea–hypopnea index (AHI) and average O2 saturation were compared. Only patients with documented CRP levels determined prior to mandibular advancement device fitting and again after improvement of OSAHS symptoms were included. Results Forty-nine patients (77.6% male, age 47.4 ± 11.7 years, BMI 29.6 ± 5.0 kg/m2) were included in this study. Patients initially had elevated CRP levels (2.5 ± 1.8 mg/dl), which decreased significantly following use of their custom-made mandibular advancement device (1.9 ± 1.3 mg/dl, P = 0.006) by approximately 24%. AHI decreased significantly from 33.3 ± 21.7 pretreatment to 12.1 ± 22.3 posttreatment (P

It is generally assumed that mouth opening decreases the hypopharyngeal cross-sectional area (HA) and that tongue protrusion (TP) increases the HA. We hypothesize that a substantial number of patients do not exhibit this expected pattern.Prospective cohort conducted at a tertiary academic center.With a flexible fiberoptic scope in position, the hypopharyngeal airway was visualized and assessed in 189 patients with the mouth closed. Patients were then asked to open the mouth with the tongue in neutral position (MOTN) to determine the effect on the airway. The same methodology was used to compare the airway with the MOTN versus TP. Basic demographics, including age, gender, body mass index, and presence and severity of obstructive sleep apnea (OSA), were collected. Student t test, Mantel-Haenszel chi-square, and Cochran-Armitage analyses were assessed for significant relationships and trends with oral positions.Although mean HA decreased with MOTN (P0.0001), 33% of patients exhibited an increase in HA. Similarly, mean HA increased with TP (P = 0.0018); however, 38% of patients demonstrated a decrease in HA. There was no significant relationship in HA between OSA and non-OSA patients. For those with OSA, increasing severity trended toward a higher incidence of smaller HA with TP (P = 0.038).The airway is typically most obstructed with mouth opening (MOTN) and most patent with tongue protrusion (TP). Nevertheless, hypopharyngeal changes with MOTN and TP followed a paradoxical pattern in one-third of our population. This may have implications in patient selection for targeted OSA treatment.4. Laryngoscope, 127:1471-1475, 2017.

This feasibility study was designed to show the preliminary safety and efficacy of targeted hypoglossal neurostimulation (THN), and to identify baseline predictors of successful therapy.Open-label, prospective, multicenter, single-arm cohort study, conducted at seven centers in the U.S.A. and Europe.Forty-six participants with moderate to severe obstructive sleep apnea (OSA), failing or intolerant of continuous positive airway pressure, were implanted. Primary (Apnea-Hypopnea Index [AHI], Oxygen Desaturation Index [ODI]) and secondary (Arousal Index, Epworth Sleepiness Scale Index, Sleep Apnea Quality of Life Index) outcomes were measured at baseline and compared at 6 months. Data were analyzed to identify participant characteristics that would predict success with therapy.Sixty-seven adverse events (AEs) were observed among 36 participants; most of the AEs were related to the implant procedure and resolved without sequelae; one device replacement was necessary. Forty-three participants showed significant (P.01) decreases in both AHI and ODI at 6 months; 35% (15 of 43) met criteria for AHI responders and 40% (17 of 43) for ODI responders. Significant improvement was observed in all the secondary endpoints. Predictors-of-success selection criteria were identified as baseline AHI65/hr, baseline apnea index ≤ 30, baseline body mass index35, and15 events/hr of SpOThis feasibility study suggests that THN therapy is likely to be safe and effective in selected patients.2b Laryngoscope, 126:2618-2623, 2016.

To investigate taste disturbance (TD) following endoscopic coblator open tongue base resection (Eco-TBR) for the treatment of obstructive sleep apnea (OSA)-hypopnea syndrome.A retrospective study in a tertiary academic medical center.Eighty patients with OSA who failed continuous positive airway pressure therapy and underwent Eco-TBR for the tongue base obstruction were enrolled in this study. Taste changes and complications were examined before and after surgery. The standard three-drop-method gustatory function test was used to study taste status preoperatively and at 7 days, 1 month, and 3 months postoperatively.Six female and 74 male patients with OSA (mean age, 42.6 years; mean apnea-hypopnea index, 48.9/hour) had a minimum follow-up of 3 months and complete data available for analysis. One patient had postoperative oral bleeding. No long-term obvious dysphagia was encountered. Twelve patients had obvious TD in the four basic tastes (sweet, sour, salty, and bitter). At 3 months postoperative time, eight patients still had changes in taste sensation; however, the TD severity decreased and did not impact the patients' regular social life. The percentage of taste changes by time after Eco-TBR was between 13.8% and 17.5%.This study shows Eco-TBR may contribute to postoperative TD. The surgeons should clearly inform the OSA patient about the possibility of TDs after tongue base resection.4.

Determine the impact of nasal obstruction on efficacy, success, and adherence of Provent therapy in patients with obstructive sleep apnea (OSA).Prospective, two-arm, clinical pilot study at a single clinical site.Patients with OSA who failed continuous positive airway pressure therapy were divided into two treatment arms: arm 1 were patients with no complaints of nasal obstruction and50% nasal obstruction on exam, and arm 2 were patients with occasional complaints of nasal obstruction and 50% to 80% nasal obstruction on exam. Sleep testing at home was performed prior to the trial and on day 10 of the study with the use of Provent.Apnea-hypopnea index (AHI) decreased significantly from 20.5 ± 14.8 to 11.5 ± 16.6 (P.001) in our total patient population. Patients in arm 1 had statistically significant improvement in their AHI (18.1 ± 13.0 to 7.4 ± 10.1, P .001), oxygen desaturation index (ODI) (16.3 ± 10.8 to 8.2 ± 9.0, P.001), and minimum oxygen saturation (81.3% ± 6.7% to 86.9% ± 5.6%, P = 0.008) from baseline sleep study to sleep study 2. Patients in arm 2 had improvements in their AHI (23.4 ± 16.6 to 16.5 ± 21.4), ODI (21.5 ± 14.8 to 17.0 ± 16.0) and minimum 02 %. However, none of these reached statistical significance.In this study, Provent therapy had a high failure rate. Patients without nasal obstruction showed greater improvements using Provent than patients with obstruction. Correction of nasal obstruction may be a useful prerequisite for treatment with Provent.

To identify standard clinical parameters that may predict the optimal level of continuous positive airway pressure (CPAP) in adult patients with obstructive sleep apnea/hypopnea syndrome (OSAHS).This is a retrospective study in a tertiary academic medical center that included 129 adult patients (117 males and 12 females) with OSAHS confirmed by diagnostic polysomnography (PSG).All OSAHS patients underwent successful full-night manual titration to determine the optimal CPAP pressure level for OSAHS treatment. The PSG parameters and completed physical examination, including body mass index, tonsil size grading, modified Mallampati grade (also known as updated Friedman's tongue position [uFTP]), uvular length, neck circumference, waist circumference, hip circumference, thyroid-mental distance, and hyoid-mental distance (HMD) were recorded.When the physical examination variables and OSAHS disease were correlated singly with the optimal CPAP pressure, we found that uFTP, HMD, and apnea/hypopnea index (AHI) were reliable predictors of CPAP pressures (P = .013, P = .002, and P.001, respectively, by multiple regression). When all important factors were considered in a stepwise multiple linear regression analysis, a significant correlation with optimal CPAP pressure was formulated by factoring the uFTP, HMD, and AHI (optimal CPAP pressure = 1.01 uFTP + 0.74 HMD + 0.059 AHI - 1.603).This study distinguished the correlation between uFTP, HMD, and AHI with the optimal CPAP pressure. The structure of the upper airway (especially tongue base obstruction) and disease severity may predict the effective level of CPAP pressure.4.

To determine the effect of treatment of obstructive sleep apnea (OSA) with custom-made mandibular advancement devices (MADs) on C-reactive protein (CRP) levels in patients with obstructive sleep apnea/hypopnea syndrome (OSAHS).Case series with chart review.Charts of consecutive patients fitted with custom-made mandibular advancement devices for treatment of OSAHS between December 2011 and November 2012 were reviewed. Demographics such as age, sex, and body mass index (BMI) were collected. Prefitting and postfitting polysomnograms were reviewed. Pre- and posttreatment apnea-hypopnea index (AHI) and average O2 saturation were compared. Only patients with documented CRP levels determined prior to mandibular advancement device fitting and again after improvement of OSAHS symptoms were included.Forty-nine patients (77.6% male, age 47.4 ± 11.7 years, BMI 29.6 ± 5.0 kg/m(2)) were included in this study. Patients initially had elevated CRP levels (2.5 ± 1.8 mg/dl), which decreased significantly following use of their custom-made mandibular advancement device (1.9 ± 1.3 mg/dl, P = 0.006) by approximately 24%. AHI decreased significantly from 33.3 ± 21.7 pretreatment to 12.1 ± 22.3 posttreatment (P0.001). Treatment with MADs reduced AHI by approximately 69.3%. Minimum oxygen saturation significantly improved from 85.1% ± 5.9 pretreatment to 90.7% ± 3.6 posttreatment (P0.001).Treatment with custom-made mandibular advancement devices significantly reduced elevated CRP levels in patients with mild to severe OSAHS. Therapy achieves reasonable response and cure rates in the observed patients with a significant reduction in AHI.