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  • Examining the Mechanism of Action of a New Device Using Oral Pressure Therapy for the Treatment of Obstructive Sleep Apnea SLEEP Schwab, R. J., Kim, C., Siegel, L., Keenan, B. T., Black, J., Farid-Moayer, M., Podmore, J., Vaska, M. 2014; 37 (7): 1237-1247

    Abstract

    The objective of this study was to explore the mechanism of action of the oral pressure therapy (OPT) device, a new treatment for sleep apnea.Case series.Academic medical center.Fifteen subjects with sleep apnea who had been successfully treated (responders) with the OPT device and 4 subjects who were not successfully treated (non-responders) with the OPT device.All subjects underwent a MRI (without the device, with the device in place without vacuum and with the device in place with vacuum) to examine the biomechanical changes associated with the OPT device.Oral pressure therapy significantly (P = 0.002) increased the size of the retropalatal airway in both the lateral and anterior-posterior dimensions by moving the soft palate anteriorly and superiorly and the anterior-superior segment of the tongue forward, toward the teeth. The percentage and absolute increase in the cross-sectional area of the retropalatal region, the superior movement of the soft palate, and the anterior displacement of the tongue were significantly greater in the responders than in the non-responders. In responders, there were significant increases in the mean (P = 0.002), maximum (P = 0.0002), and minimum (P = 0.04) cross-sectional areas of the retropalatal region with the OPT device. However, in the retroglossal region, airway caliber decreased with the OPT device.In those who responded to oral pressure therapy, it increased airway caliber in the retropalatal region by moving the soft palate anteriorly and superiorly and the anterior-superior segment of the tongue forward.Schwab RJ, Kim C, Siegel L, Keenan BT, Black J, Farid-Moayer M, Podmore J, Vaska M. Examining the mechanism of action of a new device using oral pressure therapy for the treatment of obstructive sleep apnea.

    View details for DOI 10.5665/sleep.3846

    View details for Web of Science ID 000338847400012

    View details for PubMedCentralID PMC4098809

  • Examining the mechanism of action of a new device using oral pressure therapy for the treatment of obstructive sleep apnea. Sleep Schwab, R. J., Kim, C., Siegel, L., Keenan, B. T., Black, J., Farid-Moayer, M., Podmore, J., Vaska, M. 2014; 37 (7): 1237-1247

    Abstract

    The objective of this study was to explore the mechanism of action of the oral pressure therapy (OPT) device, a new treatment for sleep apnea.Case series.Academic medical center.Fifteen subjects with sleep apnea who had been successfully treated (responders) with the OPT device and 4 subjects who were not successfully treated (non-responders) with the OPT device.All subjects underwent a MRI (without the device, with the device in place without vacuum and with the device in place with vacuum) to examine the biomechanical changes associated with the OPT device.Oral pressure therapy significantly (P = 0.002) increased the size of the retropalatal airway in both the lateral and anterior-posterior dimensions by moving the soft palate anteriorly and superiorly and the anterior-superior segment of the tongue forward, toward the teeth. The percentage and absolute increase in the cross-sectional area of the retropalatal region, the superior movement of the soft palate, and the anterior displacement of the tongue were significantly greater in the responders than in the non-responders. In responders, there were significant increases in the mean (P = 0.002), maximum (P = 0.0002), and minimum (P = 0.04) cross-sectional areas of the retropalatal region with the OPT device. However, in the retroglossal region, airway caliber decreased with the OPT device.In those who responded to oral pressure therapy, it increased airway caliber in the retropalatal region by moving the soft palate anteriorly and superiorly and the anterior-superior segment of the tongue forward.Schwab RJ, Kim C, Siegel L, Keenan BT, Black J, Farid-Moayer M, Podmore J, Vaska M. Examining the mechanism of action of a new device using oral pressure therapy for the treatment of obstructive sleep apnea.

    View details for DOI 10.5665/sleep.3846

    View details for PubMedID 25061252

    View details for PubMedCentralID PMC4098809

  • A multicenter evaluation of oral pressure therapy for the treatment of obstructive sleep apnea SLEEP MEDICINE Colrain, I. M., Black, J., Siegel, L. C., Bogan, R. K., Becker, P. M., Farid-Moayer, M., Goldberg, R., Lankford, D. A., Goldberg, A. N., Malhotra, A. 2013; 14 (9): 830-837

    Abstract

    We aimed to evaluate the impact of a novel noninvasive oral pressure therapy (OPT) (Winx®, ApniCure) system on polysomnographic measures of sleep-disordered breathing, sleep architecture, and sleep stability in obstructive sleep apnea (OSA).A 4-week, multicenter, prospective, open-label, randomized, crossover, first-night order of control vs treatment, single-arm trial was conducted in five American Academy of Sleep Medicine (AASM) - accredited sleep clinics and one research laboratory. Sixty-three subjects (analysis cohort) were studied from a screening cohort of 367 subjects. The analysis cohort was 69.8% men, ages 53.6±8.9 years (mean±SD), body mass index of 32.3±4.5kg/m(2), with mild to severe OSA. At treatment initiation, subjects received random assignment to one night with and one without (control) treatment, and they were assessed again following 28 nights of treatment. Breathing and sleep architecture were assessed each night based on blind scoring by a single centralized scorer using AASM criteria.Average nightly usage across the take-home period was 6.0±1.4h. There were no severe or serious device-related adverse events (AEs). Median apnea-hypopnea index (AHI) was 27.5 events per hour on the control night, 13.4 events per hour on the first treatment night, and 14.8 events per hour after 28days of treatment. A clinically significant response (treatment AHI ⩽10/h and ⩽50% of control values) was seen in 20 of the 63 subjects evaluated. Rapid eye movement percentage (REM%) was significantly increased, and N1%, stage shifts to N1 sleep, overall stage shifts, total awakenings, and arousals per hour were all significantly reduced at both treatment nights compared to controls. Mean Epworth sleepiness scale (ESS) was significantly reduced from 12.1 to 8.6 (Cohen d effect size, 0.68) in those untreated for two or more weeks prior to OPT study participation and remained unchanged in subjects who directly switched from continuous positive airway pressure (CPAP) therapy to OPT.Clinically significant improvements in sleep quality and continuity, AHI, ODI, ESS, and overall clinical status were achieved in an easily identified subgroup. OPT was safe and well-tolerated and nightly usage was high.

    View details for DOI 10.1016/j.sleep.2013.05.009

    View details for Web of Science ID 000323603300007

    View details for PubMedID 23871259

    View details for PubMedCentralID PMC3932027

  • Oral pressure therapy for treatment of obstructive sleep apnea: clinical feasibility NATURE AND SCIENCE OF SLEEP Farid-Moayer, M., Siegel, L. C., Black, J. 2013; 5: 53–59

    Abstract

    This feasibility study examined the initial-use safety and effectiveness of a new noninvasive oral pressure therapy (OPT) system developed to treat obstructive sleep apnea (OSA).The OPT system consists of a console that connects with flexible tubing to a premanufactured polymer mouthpiece. Through the mouthpiece, a pump in the console creates oral vacuum intended to move the soft palate anteriorly to decrease obstruction of the airway during sleep. The mouthpiece was produced in ten different sizes to accommodate a range of oral dimensions. Subjects with OSA in this single-center, single-night study underwent a polysomnography (PSG) study at baseline, followed by PSG during use of OPT.Fifty-six men and 20 women, aged 50.8 ± 12.0 years (mean ± standard deviation [SD]), had OSA with apnea-hypopnea indices (AHI) greater than five events per hour at baseline. Body weight averaged 98.0 ± 18.2 kg (mean ± SD), body mass index ranged from 22.6 kg/m(2) to 57.9 kg/m(2) and averaged 32.5 ± 5.8 kg/m(2) (mean ± SD). OPT was generally well tolerated without any serious adverse events. Baseline AHI was 38.7 ± 27.5 events/hour (mean ± SD) and was reduced with treatment to 24.6 ± 25.7 events/hour (P < 0.001, Cohen's d 0.53). Treatment produced AHI less than or equal to ten events/hour in 38% of the subjects. Oxygen desaturation index was 30.1 ± 23.7 events/hour at baseline versus 15.8 ± 19.1 events/hour with treatment (P < 0.001, Cohen's d 0.66). The minimum oxygen saturation increased with treatment from 77.9 ± 8.3 to 82.2 ± 7.9 (P < 0.001, Cohen's d 0.53). Stage-N1 sleep shifts, total sleep-stage shifts, and awakenings were significantly reduced with treatment.This single-center, single-night feasibility study demonstrates that OPT can improve OSA in certain subjects identifiable by PSG during systematic usage. In appropriately responsive patients, OPT shows potential as a clinically useful new alternative for treatment of OSA without the need for custom manufacture of an oral device component.

    View details for DOI 10.2147/NSS.S44736

    View details for Web of Science ID 000213883000008

    View details for PubMedID 23750108

    View details for PubMedCentralID PMC3666154

  • A feasibility evaluation of oral pressure therapy for the treatment of obstructive sleep apnea THERAPEUTIC ADVANCES IN RESPIRATORY DISEASE Farid-Moayer, M., Siegel, L. C., Black, J. 2012; 7 (1): 3-12

    Abstract

    This feasibility study examined the initial-use safety and potential utility of a novel noninvasive oral pressure therapy (OPT) system designed to reduce airway obstruction during sleep.This was a single-center, proof-of-concept, single-treatment-night study in which subjects with obstructive sleep apnea (OSA) underwent a baseline polysomnography (PSG) study followed by PSG during use of an OPT system. The OPT system is composed of a bedside console, a polymer mouthpiece, and a flexible tube connecting the mouthpiece to the console. The console contains a pump that creates vacuum intended to pull the soft palate anteriorly and stabilize the tongue to reduce obstruction during sleep.Fifty-four men and 17 women, aged 53.2 ± 11.5 years (mean ± SD) had a baseline apnea-hypopnea index (AHI) greater than 5 events per hour. OPT was generally well tolerated with no serious adverse events. OPT significantly decreased AHI from 34.4 ± 28.9 events per hour (mean ± SD) at baseline to 20.7 ± 23.3 (p < 0.001). Treatment produced an AHI less than 10 in 48% of the subjects. OPT significantly improved oxygen desaturation index (p < 0.001) and increased the percentage of the night with oxygen saturation of 90% or greater (p = 0.028). Stage-N1 sleep shifts, total sleep-stage shifts, awakenings and the percentage of sleep time spent in N1 sleep were significantly reduced with treatment.This proof-of-concept study suggests that OPT can produce clinically relevant relief of OSA in certain subjects who are readily identified by PSG during trial use of the noninvasive system. OPT shows promise as a new treatment option for OSA in appropriate patients.

    View details for DOI 10.1177/1753465812468043

    View details for Web of Science ID 000336022500001

  • Upper airway resistance syndrome: A long-term outcome study JOURNAL OF PSYCHIATRIC RESEARCH Guilleminault, C., Kirisoglu, C., Poyares, D., Palombini, L., Leger, D., Farid-Moayer, M., Ohayon, M. M. 2006; 40 (3): 273-279

    Abstract

    This prospective study aimed to assess symptomatic evolution of patients diagnosed with Upper Airway Resistance Syndrome (UARS) four and half years after the initial UARS diagnosis. For this purpose, 138 UARS patients were contacted by mail between 43 and 69 months after the initial evaluation; 105 responded to the letter and 94 patients accepted to undergo new clinical and polysomnographic evaluations. Initial and follow-up polysomnographic recordings were scored using the same criteria.Of the 94 patients who completed the follow-up examination, none of them were using nasal CPAP. It was related to refusal by insurance providers to provide equipment based on initial apnea-hypopnea index (AHI) in 90/94 subjects. Percentage of patients with sleep related-complaints significantly increased over the four and half year period: daytime fatigue, insomnia and depressive mood increased by 12 to 20 times. Reports of sleep maintenance sleep onset insomnia and depressive mood was significantly increased. Hypnotic, antidepressant and stimulant prescription increased from initial to follow-up visit (from 11.7% to 61.7%; from 3.2% to 25.5% and from 0% to 9.6%, respectively) with antidepressant given as much for sleep disturbance as mood disorder. The polysomnography results at follow-up showed that 5 subjects had AHI compatible with Obstructive Sleep Apnea Syndrome (OSAS) but overall, respiratory disturbance index had no significant change. Total sleep time was significantly reduced compared to initial visit.Many UARS patients remained untreated following initial evaluation. Worsening of symptoms of insomnia, fatigue and depressive mood were seen with absence of treatment of UARS.

    View details for DOI 10.1016/j.jpsychires.2005.03.007

    View details for Web of Science ID 000235856500013

    View details for PubMedID 16473570