Some patients are pushing for oral appliance therapy, but it is not the right treatment for all cases.

 John Basile, BS, RRT

Obstructive sleep apnea (OSA) has a long list of associated pathologies. The scientific evidence associating sleep apnea to cardiovascular disease, stroke, diabetes, and neurocognitive defects is exhaustive.1 The viable treatment options for this serious problem consist of a much shorter list. Once the diagnosis of OSA is definitively made, the treatment options are usually arranged based on the severity of the disorder. The treatments include weight reduction, positive airway pressure (PAP) devices, surgery, and oral appliances to stabilize the airway. Whatever therapy is selected, health care professionals must carefully consider the patient’s severity of OSA, potential for adherence to treatment, and the subsequent effectiveness of that therapy.

In examining the treatment options, weight reduction frequently decreases the pressure required for airway stabilization in OSA but often does not eliminate the problem with airway occlusion. Surgical procedures are most frequently successful in mild cases of OSA and in pediatric cases where tonsillectomy is effective.2 And while PAP therapy should work for all cases of OSA, it is sometimes poorly tolerated, medically contraindicated, or impossible to utilize due to logistics or lack of an electrical power source where the patient normally sleeps.

It has been our experience at Swedish Medical Center’s Sleep Medicine Institute in Seattle that a patient’s initial introduction to the options for treatment is accompanied by his or her personal views. Some newly diagnosed OSA patients have already been influenced by negative public perceptions of PAP therapy and are predisposed against it.

The insurance industry has, in some cases, made this worse by putting certain restrictions on coverage of oral appliances that make patients think that they have to first intentionally fail with PAP therapy before they can get what they think is the more desirable alternative: oral appliance therapy. For example, coverage for an oral appliance is typically withheld until a patient fails PAP therapy, and the result is that patients sometimes state that they are preselecting oral appliance therapy and first need to fail on PAP. These same patients come to do business with a durable medical equipment (DME) provider expecting to fail using PAP therapy because they mistakenly believe oral appliances are an equally effective treatment for OSA. However, the scientific evidence is not present to support that belief.2-5

Sleep medicine providers need to present the scientific evidence regarding long-term efficacy of oral appliances so that patients can make informed decisions regarding their next steps in therapy. Recent scientific articles identifying cardiovascular risk in patients with apnea-hypopnea indices (AHIs) as low as 14 per hour call into question the use of an oral appliance in a moderate to severe case of OSA where, potentially, the AHI may be lowered to only 14 per hour.1 The careful education and re-education of patients will help them understand which mode of therapy will sufficiently lower their risks of associated diseases.

Patients typically are concerned with the encumbrance of PAP machines and the potential for social embarrassment. In this era of seemingly limitless media and information resources, patients have their opinions colored by news stories, advertisements, and friends and family members’ experiences with PAP therapy. As the percentage of patients diagnosed and treated in our general population for OSA increases, these patient-to-patient communications will increase as well. It is important that the DME industry help improve the adherence/compliance rates and the general impression of PAP therapy in our health care community and in the lay population. The interventions that work to improve adherence and compliance with patients acclimating to PAP therapy are a combination of good education and close support. The respiratory care practitioners at Swedish Sleep Therapy Supply make a contracted contact with new PAP therapy patients within the first 4 to 7 days of therapy. They then follow up at 3 weeks and 3 months into therapy. The need for more support is balanced by information from the patient reports and objective usage data from the patients’ compliance-recording PAP machines. When patients believe they need to entertain other options in the face of failure with PAP therapy, oral appliances will certainly be a first-line option.

Oral appliances, in particular mandibular repositioning (advancement) devices or MRDs, have proved to be a potentially effective option in mild to moderate cases of OSA for some patients. The MRD is the most often used oral appliance for OSA. In some published studies, the effectiveness of these appliances was reported to be 50% to 70%. It should be noted that the groups of patients in these studies had AHIs of less than 10 to 15 per hour.1-4 In patients with mild to moderate OSA, an MRD should be considered over no treatment at all.4 The American Sleep Disorders Association (ASDA, now the American Academy of Sleep Medicine) practice parameters state that oral appliances are indicated for snoring and mild OSA as a primary device and in moderate sleep apnea only when PAP therapy has failed. Long-term adherence for patients using MRDs has been reported to be 60%.6-9

Many Device Options
MRDs come in various types. The simplest is a “boil-and-bite” version that requires no technical intervention by a dentist. In contrast, it should be noted that these types of devices have a fixed amount of mandibular advancement and do not offer the ability to open the airway more to affect efficacy of the device. The more complex type of MRD is fabricated by a dentist and requires dental impressions of both the upper and lower teeth. These devices allow the dentist to slowly adjust the mandible forward to improve the airway lumen thereby decreasing the obstructive events. The gradual increase in mandibular protrusion improves comfort in the initial stages and therefore adherence by the patient. The amount of protrusion is increased until snoring and OSA symptoms improve. The patient should return to the sleep laboratory for a study to demonstrate efficacy, if possible.5

Contraindications for oral appliances include insufficient teeth to support the oral appliance, periodontal problems, active temporomandibular joint (TMJ), disorder, and maximum mandibular protrusion distance of less than 6 mm. In a study of 100 unselected polysomnography subjects examined by maxillofacial surgeons, 31% had an insufficient number of teeth, 16% had periodontal abnormalities that would require prior treatment, and 2% had a significant TMJ disorder.

Side effects of MRDs include increased salivation, dental pain, and TMJ pain. Other long-term side effects may include tooth movement and changes in the patient’s ability to bite properly.3.4,6 To guard against these potential problems, it is suggested that patients with oral appliances should make periodic visits to a dentist. In addition, concurrent follow-up with a sleep physician is recommended to monitor adherence to therapy and symptom control. Most patients discontinuing use of their oral appliance do so due to discomfort.4 In a recently published case presentation, a woman utilized an MRD oral appliance successfully after failing CPAP therapy and uvulopalatopharyngoplasty (UPPP) surgery. The UPPP surgery was deemed ineffective after 5 months postoperative.3

While MRDs should be considered in patients with mild to moderate OSA who are intolerant of PAP therapy, oral appliances may be useful for patients who have a lifestyle that may make daily use of PAP therapy impossible. In working with the sleep apneic population on PAP therapy, I have found that some patients enjoy bike rides or backpacking trips that make use of an electrically powered PAP device nearly impossible. In these situations, an oral appliance will decrease snoring and obstructive events enough to allow them to comfortably enjoy their various outdoor interests. I am careful to make the point with the patient that the oral appliance ordered by their sleep provider is a temporary treatment and will most likely not lower their AHI to safe levels.

In addition, the experimental use of an oral appliance in conjunction with CPAP has been documented.7,8 Theoretically, the use of an oral appliance may decrease the pressure required for airway stabilization in OSA and thereby increase PAP treatment adherence and compliance. In a case study published in 2002, a patient utilized both an oral appliance and nasal CPAP successfully at night. The patient was able to decrease his positive airway pressure setting from 16 to 5.8 cm H2O and gain improved quality of life over using a single mode of therapy. Concerns over the presence of something in the mouth and the ability to maintain a tight seal are valid. However, it was noted in the study that the presence of an oral appliance created a more patent airway, and, therefore, lower nasal CPAP pressures were needed to reduce the AHI adequately. More work needs to be done in this area in order for us to potentially help the small population of OSA patients who would benefit from combined therapy. In the meantime, we can consider an oral appliance as a viable and effective alternative for some OSA patients, provided they are carefully selected, professionally fitted, well educated about the use of the device, and receive diligent, thorough follow-up care.

John Basile, BS, RRT, is manager of Swedish Sleep Therapy Supply (SSTS), which works in conjunction with the Swedish Sleep Medicine Institute, Seattle. SSTS is a hospital-based DME provider specializing in PAP therapy for sleep-disordered breathing patients. Basile is a committee chair of the American Association for Respiratory Care’s Sleep Section.

1. Newman AB, Nieto FJ, Guidry U, et al, and the Sleep Heart Health Study Research Group. Relation of sleep-disordered breathing to cardiovascular disease risk factors: the sleep heart health study [abstract]. Am J Epidemiol. 2001;154:50-59.
2. American Academy of Sleep Medicine, Clinical Practice Review Committee. Finding a cure for snoring and obstructive sleep apnea: a review of common treatments. April 14, 2005. Available at: /Topic.aspx?id=29. Accessed December 9, 2005.
3. Berry RB, Smith CL. I can’t stand CPAP. What else can you do for me? J Clin Sleep Med. 2005;1:91-93.
4. Almeida FR, Lowe AA, Tsuiki S, et al. Long-term compliance and the side effects of oral appliances used for the treatment of snoring and obstructive sleep apnea syndrome. J Clin Sleep Med. 2005;1:143-149
5. Pascualy R, ed. Progress in Oral Appliances for the Treatment of Obstructive Sleep Apnea. Seattle: Swedish Sleep Medicine Institute-Sleep Review; 2005.
6. Lim J, Lasserson TJ, Fleetham J, Wright J. Oral appliances for obstructive sleep apnoea. Cochrane Database Syst Rev. 2004;18:CD004435.
7. Nakajima T, Hayama T, Ohkushi T, et al. Approach to obstructive sleep apnea syndrome at Tokyo Dental College, Ichikawa General Hospital. Bull Tokyo Dent Coll. 2004;45:181-187.
8. Denbar MA. A case study involving the combination treatment of an oral appliance and auto-titrating CPAP unit. Sleep Breath. 2002;6:125-128.

The Role of Mandibular Advancements Splint Devices

by John Swieca, MBBS FRACP

Obstructive sleep apnea (OSA) is an increasingly common disorder. We now understand that OSA is associated with premature cardiovascular disease as well as impaired neurocognitive function and reduced quality of life. Great advances have been made in some treatments for sleep apnea. New technologies and a greater understanding of sleep apnea have led to vast improvements in continuous positive airway pressure (CPAP) and mandibular advancements splint (MAS) devices, making it easier to move away from more invasive measures, such as surgery.

There is little doubt that upper airway surgery has a place in nonapneic snorers, and radiofrequency palatoplasty (somnoplasty) has been shown to reduce snoring—but not sleep apnea.1 Uvulopalatopharyngoplasty has variable success rates in treating apnea. This surgery can often prove difficult for the patient due to the long recovery time, the risk of bleeding or infection, and the changes that may occur in their voice.2 Tongue base reduction has been tried, but, overall, surgery has not radically changed in recent years.

For moderate to severe OSA, nasal CPAP is ideal but requires longer acclimatization and has extremely variable—and at times dismally low—compliance rates. It still remains the first-line treatment for severe sleep apnea. Mechanical treatment options have been greatly enhanced in recent years with the development and refinement of the MAS.

MAS devices have become first-line treatment in mild to moderate sleep apnea and the second-line treatment in severe sleep OSA. These devices that facilitate and maintain lower jaw protrusion during sleep have meant great advances in treatment benefit. More recent studies3 with MAS devices have shown benefit not only in apnea severity but also in secondary general health consequences of the OSA disorder.

It seems the more comfortable the device, the higher the compliance rate, although it is difficult to carry out objective studies into this link. All we can rely on is patient feedback, which I believe is highly likely to be positive with MAS devices, despite frequent initial discomforts during the acclimatization phase. Titratable devices can allow the professional and patient to strike a balance between comfort and efficacy. The reduced vertical height and broad areas of contact inherent in some newer MAS devices may offer better long-term safety and general dental health, although outcome studies are yet to be performed in patients who may be wearing a MAS for decades. Ongoing refinements in technology are designed to make MAS devices more comfortable and therefore improve compliance.

Clinical trials have often shown greater patient preference for an oral appliance over nasal CPAP, when presented both forms of therapy in random order.4 For patients whose CPAP fails, better compliance may be found with oral appliances. Although MAS devices are more suited to mild to moderate apnea, I believe increasing numbers of severe sleep apnea patients will benefit from MAS devices in the future as either a primary or adjunctive therapy. CPAP and MAS devices will continue to be the mainstays in the future care of sleep apnea patients. The pair are likely to maintain a leading role in OSA therapeutics. However, lifestyle modification programs, weight loss drugs, and weight reduction surgery will be increasingly necessary in the attempt to treat the obesity and sleep apnea epidemic that is already upon us.

But, as a friend of mine once said, treating sleep apnea is more like farming than mining—you never get to the bottom of it.

John Swieca, MBBS FRACP, is medical director of the Melbourne Sleep Disorders Centre at Mercy Private Hospital, East Melbourne, Australia.

1. Sher AE, Flexon PB, Hillman D, et al. Temperature-controlled radiofrequency tissue volume reduction in the human soft palate. Otolaryngol Head Neck Surg. 2001;125:312-8.
2. Sundaram S, Bridgman S, Lim J, Lasserson T, Sundaram S. Surgery for obstructive sleep apnoea. Cochrane Database Syst Rev. 2005;19:CD001004.
3. Gotsopoulos H, Kelly JJ, Cistulli PA. Oral appliance therapy reduces blood pressure in obstructive sleep apnea: a randomized, controlled trial. Sleep. 2004;27:934-41.
4. 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;170:656-64.