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obstructive sleep apnoea: results of a randomised placebo controlled trial using parallel group design. J Sleep Res. 2008;17(2):221-229. 24. Barnes M, McEvoy RD, Banks S, et al. Efficacy of positive airway pressure and oral appliance in mild to moderate obstructive sleep apnea. Am J Respir Crit Care Med. 2004;170(6):656-664. 25. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. J Pharmacol Pharmacother. 2010;1(2):100-107. 26. Partinen M, Gislason T. Basic Nordic Sleep Questionnaire (BNSQ): a quantitated measure of subjective sleep complaints. J Sleep Res. 1995;4(S1): 150-155. 27. Friedman M, Tanyeri H, La Rosa M, et al. Clinical predictors of obstructive sleep apnea. Laryngoscope. 1999;109(12):1901-1907. 28. Marklund M, Stenlund H, Franklin KA. Mandibular advancement devices in 630 men and women with obstructive sleep apnea and snoring: tolerability and predictors of treatment success. Chest. 2004;125(4):1270-1278. 29. Herbst E. Dreissigjährige Erfahrungen mit dem Retentions-Scharnier. Zahnärztl Rundschau. 1934;43:1563–1568, 1515-1524,1563-1568, 1611-1616. 30. Kaida K, Takahashi M, Akerstedt T, et al Validation of the Karolinska sleepiness scale against performance and EEG variables. Clin Neurophysiol. 2006;117(7):1574-1581. 31. Priest B, Brichard C, Aubert G, Liistro G, Rodenstein DO. Microsleep during a simplified maintenance of wakefulness test: a validation study of the OSLER test. Am J Respir Crit Care Med. 2001; 163(7):1619-1625. 32. Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991;14(6):540-545.

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34. Weaver TE, Laizner AM, Evans LK, et al. An instrument to measure functional status outcomes for disorders of excessive sleepiness. Sleep. 1997; 20(10):835-843.

scores in obstructive sleep apnea syndrome patients with and without restless legs syndrome after nasal CPAP. Arq Neuropsiquiatr. 2007;65(1): 54-58.

35. Allen RP, Picchietti D, Hening WA, Trenkwalder C, Walters AS, Montplaisi J; Restless Legs Syndrome Diagnosis and Epidemiology workshop at the National Institutes of Health; International Restless Legs Syndrome Study Group. Restless legs syndrome: diagnostic criteria, special considerations, and epidemiology: a report from the restless legs syndrome diagnosis and epidemiology workshop at the National Institutes of Health. Sleep Med. 2003;4(2):101-119.

42. Alberti A, Mazzotta G, Gallinella E, Sarchielli P. Headache characteristics in obstructive sleep apnea syndrome and insomnia. Acta Neurol Scand. 2005; 111(5):309-316.

36. Olesen J, Steiner TJ. The International classification of headache disorders, 2nd ed (ICDH-II). J Neurol Neurosurg Psychiatry. 2004;75 (6):808-811. 37. Sleep-related breathing disorders in adults: recommendations for syndrome definition and measurement techniques in clinical research: the report of an American Academy of Sleep Medicine Task Force. Sleep. 1999;22(5):667-689. 38. Rechtschaffen AKA. A manual of standardized terminology, techniques, and scoring system for sleep stages of human subjects. Los Angeles: Barin Information Service/Brain Research Institute; 1968. 39. Naismith SL, Winter VR, Hickie IB, Cistulli PA. Effect of oral appliance therapy on neurobehavioral functioning in obstructive sleep apnea: a randomized controlled trial. J Clin Sleep Med. 2005;1(4):374-380. 40. Garcia-Borreguero D, Williams AM. An update on restless legs syndrome (Willis-Ekbom disease): clinical features, pathogenesis, and treatment. Curr Opin Neurol. 2014;27(4):493-501.

43. Kristiansen HA, Kværner KJ, Akre H, Overland B, Russell MB. Tension-type headache and sleep apnea in the general population. J Headache Pain. 2011;12(1):63-69. 44. Johnson KG, Ziemba AM, Garb JL. Improvement in headaches with continuous positive airway pressure for obstructive sleep apnea: a retrospective analysis. Headache. 2013;53 (2):333-343. 45. Bondemark L, Lindman R. Craniomandibular status and function in patients with habitual snoring and obstructive sleep apnoea after nocturnal treatment with a mandibular advancement splint: a 2-year follow-up. Eur J Orthod. 2000;22(1):53-60. 46. Fransson AM, Tegelberg A, Johansson A, Wenneberg B. Influence on the masticatory system in treatment of obstructive sleep apnea and snoring with a mandibular protruding device: a 2-year follow-up. Am J Orthod Dentofacial Orthop. 2004; 126(6):687-693. 47. Marklund M, Franklin KA. Long-term effects of mandibular repositioning appliances on symptoms of sleep apnoea. J Sleep Res. 2007;16(4):414-420. 48. Oksenberg A, Silverberg DS. The effect of body posture on sleep-related breathing disorders: facts and therapeutic implications. Sleep Med Rev. 1998;2(3):139-162.

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Invited Commentary

Mandibular Advancement Therapy for Obstructive Sleep Apnea Answers and (More) Questions Winfried J. Randerath, MD

Obstructive sleep apnea (OSA) is a major medical challenge: it affects 4% to 13% of the general population, impairs quality of life, and substantially increases the risk of motor vehicle accidents. Obstructive sleep apnea is associated with carRelated article page 1278 diovascular and metabolic consequences and increased mortality, particularly among the most severely affected patients. In severe OSA, the most effective treatment for respiratory dysfunction is continuous positive airway pressure (CPAP).1 However, many patients suffer from mild to moderate OSA, as indicated by the numbers of apneas and hypopneas per hour (mild, 5-15/hour; moderate, 15-30/hour; severe, >30/hour), often presenting to the primary care phy-

sician with disturbed sleep, daytime sleepiness, or impaired cognitive functions. The long-term effect of mild to moderate OSA is less clear. What is the most effective and most feasible treatment option for these patients? Because of the discomfort of CPAP, patients seek less burdensome and complex alternatives. However, there is a paucity of evidence to support the use of surgical, orthodontic, or more conservative approaches.2 One intervention for which promising data are beginning to emerge are relatively simple devices that move the mandible into a more anterior position to treat OSA, known as mandibular advancement devices (MADs).3 These oral appliances reposition the lower jaw forward and downwards and widen the upper airways, thus improving upper

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air way patency and reduc ing snoring and breathing disturbances. There is a huge spectrum in types and varieties of intraoral appliances, ranging from selfm o d u l ate d b o i l - a n d - b ite s y s te m s to f u l l y b e s p o ke devices, the latter being individually adapted and produced by specially qualified dentists. A recent health technology assessment 4 analyzed 7 7 randomized clinic al trials comparing MADs with other non-CPAP therapies or CPAP. Although CPAP was superior in terms of respiratory disturbances, there were no differences in daytime sleepiness. In this issue of JAMA Internal Medicine, Marklund et al5 present the results of a randomized clinical trial comparing an individually adjusted MAD vs placebo in patients with snoring or mild to moderate OSA. They focused on the clinically relevant and challenging group of patients who have impaired daytime performance but do not have a clear indication for treatment in terms of improving survival and cardiovascular outcomes. The authors showed a significant reduction of obstructive apneas and hypopneas and snoring with use of a MAD. Moreover, the MAD improved daytime sleepiness and quality of life as compared with baseline and was superior to placebo in snoring and symptoms of restless legs. Therefore, it can be stated that the MAD was effective in this group of patients w ith symptomatic mild to moderate OSA. Interestingly, neither the MAD nor placebo improved sleep parameters or neurocognitive tests. Several subjective parameters improved with both, and no subjective parameter was significantly better improved with a MAD. Placebo was so successful that as much as 52% of placebo patients were interested in continuing placebo treatment. These findings illustrate the importance of a sham control group, particularly when studies use subjective outcome measures. It is noteworthy that many previous studies on treatment alternatives were mainly based on unvalidated questionnaires or witnessed symptoms and used uncontrolled designs. Further research to evaluate quality-of-life and performance parameters is urgently needed, before treatment in mild to moderate OSA can generally be recommended. It is a strength of the study by Marklund et al that efficacy was evaluated using polysomnography, validated self-assessment questionnaires, and objective vigilance tests. Additional questions remain open and require scientific data in different clinical entities: eg, efficacy and influence of MADs on long-term morbidity and mortality in severe OSA. What does optimal treatment in mild OSA mean? The prevalence of daytime symptoms or preexisting cardiovascular comorbidities suggests there are widespread needs for better treatments for mild to moderate OSA. In addition to previous data, the article by Marklund et al underlines that MADs may be used as an alternative to CPAP for these patients. The choice for one or the other therapy depends on patients’ acceptance, dental and oral conditions, and individual response. In contrast, snoring or mild OSA (without impairment of daytime functioning or cardiometabolic disorders) does not generally support the need for treatment.

Survival benefits have been shown in severe OSA when sufficiently treated with CPAP. Thus, CPAP treatment of severe OSA is generally recommended to reduce the risk of cardiovascular consequences—independent of clinical symptoms. To date, there are little data on the influence of MADs on cardiovascular parameters. Some studies have failed to show differences in arterial hypertension with CPAP or MAD. In fact, neither method influenced hypertension at all in these studies.6 Nevertheless, CPAP improves blood pressure in treatment-refractory hypertension. Under MADs, interesting data have been published on cardiovascular markers or arterial tone but are preliminary in nature.7 Therefore, randomized CPAP-controlled trials on the effic ac y of MADs on c ardiovasc ular parameters are needed. The huge variety of MADs is an important issue to consider when making treatment recommendations. Differences in the extent of the protrusion and in the stability of the material and structural design influence comfort and adverse effects and may account for substantial differences in the suppression of respiratory disturbances.4 Therefore, the results from clinical trials have to be interpreted critically and must not simply be generalized to other devices: the design and construction of these devices have not been standardized. Less sophisticated devices that are not deliberately tailored to an individual’s jaw and oral space may be less expensive and as effective as individually adapted devices or CPAP. However, this has to be proven scientifically and individually. At the moment, statements from several countries recommend custommade adjustable devices produced by a trained or specialized person. The decision to recommend MAD use includes not only consideration of the device’s effectiveness (and safety) but also likelihood of adherence to treatment and other associated costs. For patients with severe OSA, CPAP is more effective in terms of respiratory disturbances and outcomes. However, patients in general evidently prefer MADs. Better adherence to MAD therapy, in fact, may outweigh its decreased effectiveness. Long-term studies that examine the effect of these 2 types of therapies on patient-important clinical end points in OSA are needed. However, for patients with mild to moderate OSA, the decision to recommend MADs or CPAP is less clear. Interestingly, a recent review d e s c r i b e d b o t h C PA P a n d M A D s a s b e i ng s i m i l a r l y c o s t - e f f e c t i ve . 4 U n f o r t u n a t e l y, d e t e r m i n i ng c o s t effectiveness becomes increasingly difficult because of the rapidly changing pricing for devices and support. The costs of MADs may vary from $50 (boil-and-bite devices) to more than $1000 (fully bespoke adjustable devices); CPAP devices cost between $150 and $2000. The study by Marklund et al improves our understanding of the effectiveness of MADs for our patients with mild to moderate OSA with relevant daytime sleepiness. However, it also illustrates the difficulty of determining the effect of this device on patients’ quality of life. Results from well-experienced groups using highly sophistic ated approaches and devices may not be simply translated to other appliances.

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Oral Appliance Therapy in Patients With Snoring or Moderate Sleep Apnea

ARTICLE INFORMATION Author Affiliation: Clinic of Pneumology and Allergology Center for Sleep Medicine and Respiratory Care, Bethanien Hospital, Solingen, Germany. Corresponding Author: Winfried J. Randerath, MD, Clinic of Pneumology and Allergology Center for Sleep Medicine and Respiratory Care, Bethanien Hospital, Aufderhöher Straße 169-175, 42699 Solingen, Germany ([email protected]). Published Online: June 1, 2015. doi:10.1001/jamainternmed.2015.2059. Conflict of Interest Disclosures: Dr Randerath has no potential conflict of interest related to this article. However, Dr Randerath has received fees for speaking and research funds from companies producing positive airway pressure devices (Weinmann, Respironics, Resmed, Heinen und Löwenstein). Additional Contributions: I would like to thank Sandhya Matthes, Klinikum d. Universität München

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Medizinische Klinik V und Poliklinik, Munich, Germany, for linguistic review. She was not compensated for her contribution.

sleep apnoea-hypopnoea (TOMADO) and long-term economic analysis of oral devices and continuous positive airway pressure. Health Technol Assess. 2014;18(67):1-296.

REFERENCES

5. Marklund M, Carlberg B, Forsgren L, Olsson T, Stenlund H, Franklin KA. Oral appliance therapy in patients with daytime sleepiness and snoring or mild to moderate sleep apnea: a randomized clinical trial [published online June 1, 2015]. JAMA Intern Med. doi:10.1001/jamainternmed.2015.2051.

1. Giles TL, Lasserson TJ, Smith BJ, White J, Wright J, Cates CJ. Continuous positive airways pressure for obstructive sleep apnoea in adults. Cochrane Database Syst Rev. 2006;(3):CD001106. 2. Randerath WJ, Verbraecken J, Andreas S, et al; European Respiratory Society task force on non-CPAP therapies in sleep apnoea. Non-CPAP therapies in obstructive sleep apnoea. Eur Respir J. 2011;37(5):1000-1028. 3. Sutherland K, Vanderveken OM, Tsuda H, et al. Oral appliance treatment for obstructive sleep apnea: an update. J Clin Sleep Med. 2014;10(2): 215-227. 4. Sharples L, Glover M, Clutterbuck-James A, et al. Clinical effectiveness and cost-effectiveness results from the randomised controlled Trial of Oral Mandibular Advancement Devices for Obstructive

6. Phillips CL, Grunstein RR, Darendeliler MA, et al. Health outcomes of continuous positive airway pressure versus oral appliance treatment for obstructive sleep apnea: a randomized controlled trial. Am J Respir Crit Care Med. 2013;187 (8):879-887. 7. Itzhaki S, Dorchin H, Clark G, Lavie L, Lavie P, Pillar G. The effects of 1-year treatment with a herbst mandibular advancement splint on obstructive sleep apnea, oxidative stress, and endothelial function. Chest. 2007;131(3):740-749.

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