Compliance with CPAP is the major limiting factor in treating patients with OSA. The novel SomnuSeal mask is an oral self-adaptable mask located between the teeth and the lips ensuring that there are no air leaks or skin abrasions. Fifty patients with , who failed previous CPAP trials, were asked to sleep with the mask for one month. In all patients, the mask was connected to an AutoPAP machine with a heated humidifier. Efficacy, convenience, and compliance (average usage for 4 or more hours per night) were monitored. Fifty patients (41？m and 9？f, mean age years, BMI ？kg/m2, and AHI /h) participated. Eleven were classified as compliant (average mask usage of 26 nights, 4.7 hours per night), five were only partially compliant (average usage of 13 nights, 2.9 hours per night), and 34 could not comply with it. In all patients who slept with it, the efficacy (assessed by residual AHI derived from the CPAP device) was good with an AHI of less than 8/hour. Interestingly, the required optimal pressure decreased from an average of 9.3？cmH2O to 4.6？cmH2O. The SomnuSeal oral interface is effective and may result in converting noncompliant untreated patients with OSA into well-treated ones. 1. Introduction Obstructive sleep apnea (OSA) is a common disorder characterized by recurrent hypoxemia, hypercapnia, and arousal from sleep and is associated with adverse neurocognitive and cardiovascular sequelae [1–6]. Application of continuous positive airway pressure (CPAP) leads to improvements in many of these adverse parameters [7–9], although residual sleep disordered breathing may still persist [10, 11]. The major limiting factor of CPAP treatment is compliance [12–14]. Some of the most important factors that have been reported as limiting compliance are skin abrasions or eruptions due to the pressure exerted by the mask, mask pressure on the ridge of the nose, claustrophobia, aerophagia, air leaks (eye irritation), dry mouth, dry nose, nasal stuffiness, epistaxis, sinusitis, facial pain or a noisy device, or pressure intolerance [15–21]. Other factors that have been identified as affecting compliance consist of disease severity, daytime sleepiness, motivation, age, socioeconomic status, education, race, marital status, spouse support, and copayment [12–31]. Even with the advanced and newer devices (such as the “C-Flex” CPAP device, BPAP, or automatic CPAP), data are not convincing for improved compliance [32–35]. Since CPAP treatment has a dramatic beneficial impact on patients [7–9, 23, 36–39], it is of great importance to seek interfaces that can improve
References
[1]
J. E. Remmers, W. J. deGroot, E. K. Sauerland, and A. M. Anch, “Pathogenesis of upper airway occlusion during sleep,” Journal of Applied Physiology Respiratory Environmental and Exercise Physiology, vol. 44, no. 6, pp. 931–938, 1978.
[2]
P. Lavie, P. Herer, and V. Hoffstein, “Obstructive sleep apnoea syndrome as a risk factor for hypertension: population study,” British Medical Journal, vol. 320, no. 7233, pp. 479–482, 2000.
[3]
P. E. Peppard, T. Young, M. Palta, and J. Skatrud, “Prospective study of the association between sleep-disordered breathing and hypertension,” The New England Journal of Medicine, vol. 342, no. 19, pp. 1378–1384, 2000.
[4]
J. Hung, E. G. Whitford, R. W. Parsons, and D. R. Hillman, “Association of sleep apnoea with myocardial infarction in men,” The Lancet, vol. 336, no. 8710, pp. 261–264, 1990.
[5]
M. E. Dyken, V. K. Somers, T. Yamada, Z. Ren, and M. B. Zimmerman, “Investigating the relationship between stroke and obstructive sleep apnea,” Stroke, vol. 27, no. 3, pp. 401–407, 1996.
[6]
U. Leuenberger, E. Jacob, L. Sweer, N. Waravdekar, C. Zwillich, and L. Sinoway, “Surges of muscle sympathetic nerve activity during obstructive apnea are linked to hypoxemia,” Journal of Applied Physiology, vol. 79, no. 2, pp. 581–588, 1995.
[7]
J. Hedner, B. Darpo, H. Ejnell, J. Carlson, and K. Caidahl, “Reduction in sympathetic activity after long-term CPAP treatment in sleep apnoea: cardiovascular implications,” European Respiratory Journal, vol. 8, no. 2, pp. 222–229, 1995.
[8]
K. Narkiewicz, M. Kato, B. G. Phillips, C. A. Pesek, D. E. Davison, and V. K. Somers, “Nocturnal continuous positive airway pressure decreases daytime sympathetic traffic in obstructive sleep apnea,” Circulation, vol. 100, no. 23, pp. 2332–2335, 1999.
[9]
J. M. Marin, S. J. Carrizo, E. Vicente, and A. G. N. Agusti, “Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study,” The Lancet, vol. 365, no. 9464, pp. 1046–1053, 2005.
[10]
D. P. White and T. J. Gibb, “Evaluation of the Healthdyne NightWatch system to titrate CPAP in the home,” Sleep, vol. 21, no. 2, pp. 198–204, 1998.
[11]
A. I. Pack, J. E. Black, J. R. L. Schwartz, and J. K. Matheson, “Modafinil as adjunct therapy for daytime sleepiness in obstructive sleep apnea,” American Journal of Respiratory and Critical Care Medicine, vol. 164, no. 9, pp. 1675–1681, 2001.
[12]
M. R. DiMatteo, “Variations in patients' adherence to medical recommendations: a quantitative review of 50 years of research,” Medical Care, vol. 42, no. 3, pp. 200–209, 2004.
[13]
N. B. Kribbs, A. I. Pack, L. R. Kline et al., “Objective measurement of patterns of nasal CPAP use by patients with obstructive sleep apnea,” American Review of Respiratory Disease, vol. 147, no. 4, pp. 887–895, 1993.
[14]
T. E. Weaver, N. B. Kribbs, A. I. Pack et al., “Night-to-night variability in CPAP use over the first three months of treatment,” Sleep, vol. 20, no. 4, pp. 278–282, 1997.
[15]
H. M. Engleman, N. Asgari-Jirhandeh, A. L. McLeod, C. F. Ramsay, I. J. Deary, and N. J. Douglas, “Self-reported use of CPAP and benefits of CPAP therapy: a patient survey,” Chest, vol. 109, no. 6, pp. 1470–1476, 1996.
[16]
J. Strollo Jr., M. H. Sanders, and C. W. Atwood, “Positive pressure therapy,” Clinics in Chest Medicine, vol. 19, no. 1, pp. 55–68, 1998.
[17]
J. L. Pepin, P. Leger, D. Veale, B. Langevin, D. Robert, and P. Levy, “Side effects of nasal continuous positive airway pressure in sleep apnea syndrome: study of 193 patients in two French sleep centers,” Chest, vol. 107, no. 2, pp. 375–381, 1995.
[18]
G. N. Richards, P. A. Cistulli, R. G. Ungar, M. Berthon-Jones, and C. E. Sullivan, “Mouth leak with nasal continuous positive airway pressure increases nasal airway resistance,” American Journal of Respiratory and Critical Care Medicine, vol. 154, no. 1, pp. 182–186, 1996.
[19]
S. A. Herrejon, A. I. Inchaurraga, and M. Gonzalez, “Spontaneous pneumothorax associated with the use of nighttime BiPAP with a nasal mask,” Archivos de Bronconeumología, vol. 34, no. 10, p. 512, 1998.
[20]
R. Alvarez-Sala, S. Diaz, C. Prados, C. Villasante, and J. Villamor, “Increase of intraocular pressure during nasal CPAP,” Chest, vol. 101, no. 5, p. 1477, 1992.
[21]
N. N. Jarjour and P. Wilson, “Pneumocephalus associated with nasal continuous positive airway pressure in a patient with sleep apnea syndrome,” Chest, vol. 96, no. 6, pp. 1425–1426, 1989.
[22]
N. McArdle, G. Devereux, H. Heidarnejad, H. M. Engleman, T. W. Mackay, and N. J. Douglas, “Long-term use of CPAP therapy for sleep apnea/hypopnea syndrome,” American Journal of Respiratory and Critical Care Medicine, vol. 159, no. 4 I, pp. 1108–1114, 1999.
[23]
A. Tarasiuk, G. Reznor, S. Greenberg-Dotan, and H. Reuveni, “Financial incentive increases CPAP acceptance in patients from low socioeconomic background,” PLoS ONE, vol. 7, no. 3, Article ID e33178, 2012.
[24]
F. Campos-Rodriguez, N. Pe？a-Gri？an, N. Reyes-Nu？ez et al., “Mortality in obstructive sleep apnea-hypopnea patients treated with positive airway pressure,” Chest, vol. 128, no. 2, pp. 624–633, 2005.
[25]
T. E. Weaver, “How much is enough CPAP?” Sleep Medicine, vol. 4, article S52, 2003.
[26]
L. E. Burke and I. S. Ockene, Compliance in Healthcare and Research, Futura Publishing, Armonk, NY, USA, 2001.
[27]
H. M. Engleman, S. E. Martin, and N. J. Douglas, “Compliance with CPAP therapy in patients with the sleep apnoea/hypopnoea syndrome,” Thorax, vol. 49, no. 3, pp. 263–266, 1994.
[28]
T. Simon-Tuval, H. Reuveni, S. Greenberg-Dotan, A. Oksenberg, A. Tal, and A. Tarasiuk, “Low socioeconomic status is a risk factor for CPAP acceptance among adult OSAS patients requiring treatment,” Sleep, vol. 32, no. 4, pp. 545–552, 2009.
[29]
C. A. Massie, R. W. Hart, K. Peralez, and G. N. Richards, “Effects of humidification on nasal symptoms and compliance in sleep apnea patients using continuous positive airway pressure,” Chest, vol. 116, no. 2, pp. 403–408, 1999.
[30]
M. E. Billings, D. Auckley, R. Benca et al., “Race and residential socioeconomics as predictors of CPAP adherence,” Sleep, vol. 34, no. 12, pp. 1653–1658, 2011.
[31]
L. Ye, A. I. Pack, G. Maislin et al., “Predictors of continuous positive airway pressure use during the first week of treatment,” Journal of Sleep Research, vol. 21, no. 4, pp. 419–426, 2012.
[32]
J. Bakker, A. Campbell, and A. Neill, “Randomized controlled trial comparing flexible and continuous positive airway pressure delivery: effects on compliance, objective and subjective sleepiness and vigilance,” Sleep, vol. 33, no. 4, pp. 523–529, 2010.
[33]
J. Pépin, J. Muir, T. Gentina et al., “Pressure reduction during exhalation in sleep apnea patients treated by continuous positive airway pressure,” Chest, vol. 136, no. 2, pp. 490–497, 2009.
[34]
D. C. Dolan, R. Okonkwo, F. Gfullner, R. J. Hansbrough, R. J. Strobel, and L. Rosenthal, “Longitudinal comparison study of pressure relief (C-Flex) versus CPAP in OSA patients,” Sleep and Breathing, vol. 13, no. 1, pp. 73–77, 2009.
[35]
N. S. Marshall, A. M. Neill, and A. J. Campbell, “Randomised trial of compliance with flexible (C-Flex) and standard continuous positive airway pressure for severe obstructive sleep apnea,” Sleep and Breathing, vol. 12, no. 4, pp. 393–396, 2008.
[36]
S. K. Sharma, S. Agrawal, D. Damodaran et al., “CPAP for the metabolic syndrome in patients with obstructive sleep apnea,” The New England Journal of Medicine, vol. 365, no. 24, pp. 2277–2286, 2011.
[37]
I. H. Iftikhar, M. F. Khan, A. Das, and U. J. Magalang, “Meta-analysis: continuous positive airway pressure improves insulin resistance in patients with sleep apnea without diabetes,” Annals of the American Thoracic Society, vol. 10, no. 2, pp. 115–120, 2013.
[38]
M. A. Martínez-García, F. Campos-Rodríguez, P. Catalán-Serra et al., “Cardiovascular mortality in obstructive sleep apnea in the elderly: role of long-term continuous positive airway pressure treatment: a prospective observational study,” American Journal of Respiratory and Critical Care Medicine, vol. 186, no. 9, pp. 909–916, 2012.
[39]
T. G. Weinstock, X. Wang, M. Rueschman et al., “A controlled trial of CPAP therapy on metabolic control in individuals with impaired glucose tolerance and sleep apnea,” Sleep, vol. 35, no. 5, pp. 617–625, 2012.
[40]
G. Pillar, S. Suraiya, A. Segev, and M. Majdob, “A novel oral mask improve convenience in CPAP treated OSA patients,” Sleep, vol. 33, article A168, 2010.
[41]
G. Pillar, A. Segev, and E. Kurtz, “The SomnuSeal oral mask is reasonably tolerated by otherwise CPAP non compliant patients with OSA,” Sleep, vol. 35, article A164, 2012.
[42]
J. C. Borel, R. Tamisier, S. Dias-Domingos et al., “Type of mask may impact on continuous positive airway pressure adherence in apneic patients,” PLoS ONE, vol. 8, no. 5, Article ID e64382, 2013.
[43]
V. K. Somers, D. P. White, R. Amin et al., “Sleep Apnea and Cardiovascular Disease: an American Heart Association/American College of Cardiology Foundation scientific statement from the American Heart Association Council for High Blood Pressure Research Professional Education Committee, Council on Clinical Cardiology, Stroke Council, and Council on Cardiovascular Nursing,” Circulation, vol. 118, no. 10, pp. 1080–1111, 2008.
[44]
T. D. Bradley, R. M. Holloway, P. R. McLaughlin, B. L. Ross, J. Walters, and P. P. Liu, “Cardiac output response to continuous positive airway pressure in congestive heart failure,” American Review of Respiratory Disease, vol. 145, no. 2, part 1, pp. 377–382, 1992.
