Which oral appliance works best for treating sleep apnea?.

I usually know what type of oral appliance, CPAP, BiPAP or surgery will best suit my patient with obstructive sleep apnea after a short interview and exam. Success is not only efficacy of the appliance but also compliance which is a complex issue poorly addressed by randomized trials. The way the patient responds to the exam, impressions and bite often give the final clues to which treatment will be most beneficial. (many types of appliances are shown on the I HATE CPAP! site)

I present below a recent study on which appliances are the most effective. I review the information but I would like to make some personal comments about evidence based medicine and how it ignores the clinical knowledge and experience of trained physicians and dentists. Having done thousands of appliances I believe I am very adept at determining which patients will do best with various appliances. Unfortunately, clinical experience is not easy to integrate into randomized controlled studies. In fact, clinical experience and "gut feelings" about patients are ruled out of these studies. Randomized controlled studies work best with a limited number of variables. A problem many patients who try oral appliances have is that there dentist was trained by a manufacturers course and the doctor only has a single tool in his belt or only one appliance he understands and is comfortable using.

I teach a dental sleep medicine course that extensively covers the entire field of dental sleep medicine. I do give dentists who take my course a handful of appliances that are extremely effective for different patient groups. I also know that experience is vital to treating patients and therefore offer unlimited phone follow-up for 6 months with doctors that I train. I review sleep studies and frequently help them thru the diagnostic regimen to pick an appropriate appliance.

My article review follows and I include the PUB MED abstract with additional comments.

A brand new article looked at the effectiveness of various oral appliances. They found 1475 articles comparing efficacy of various appliances. The study showed that 116 of these studies compared an oral appliance to a control. They gave weight to only 14 of these studies that were randomized controlled trials (RCTs). All of the studies concerned MAD or mandibular advancement devices. The study concludes that "The evidence shows that there is no one MAD design that most effectively improves polysomnographic indices, but that efficacy depends on a number of factors including severity of OSA, materials and method of fabrication, type of MAD (monobloc/twin block), and the degree of protrusion (sagittal and vertical). These findings highlight the absence of a universal definition of treatment success. Future trials of MAD designs need to be assessed according to agreed success criteria in order to guide clinical practice as to which design of OAs may be the most effective in the treatment of OSA."

Eur J Orthod. 2011 Jan 13. [Epub ahead of print]
A systematic review of the efficacy of oral appliance design in the management of obstructive sleep apnoea.
Ahrens A, McGrath C, Hägg U.

Discipline of Dental Public Health.
Abstract
Oral appliances (OAs) are increasingly advocated as a treatment option for obstructive sleep apnoea (OSA). However, it is unclear how their different design features influence treatment efficacy. The aim of this research was to systematically review the evidence on the efficacy of different OAs on polysomnographic indices of OSA. A MeSH and text word search were developed for Medline, Embase, Cinahl, and the Cochrane library. The initial search identified 1475 references, of which 116 related to studies comparing OAs with control appliances. Among those, 14 were randomized controlled trials (RCTs), which formed the basis of this review. The type of OA investigated in these trials was mandibular advancement devices (MADs), which were compared with either inactive appliances (six studies) or other types of MADs with different design features. Compared with inactive appliances, all MADs improved polysomnographic indices, suggesting that mandibular advancement is a crucial design feature of OA therapy for OSA. The evidence shows that there is no one MAD design that most effectively improves polysomnographic indices, but that efficacy depends on a number of factors including severity of OSA, materials and method of fabrication, type of MAD (monobloc/twin block), and the degree of protrusion (sagittal and vertical). These findings highlight the absence of a universal definition of treatment success. Future trials of MAD designs need to be assessed according to agreed success criteria in order to guide clinical practice as to which design of OAs may be the most effective in the treatment of OSA.

PMID: 21239397 [PubMed - as supplied by publisher]

The article states " These findings highlight the absence of a universal definition of treatment success." The definition of success should be the elimination of all obstructive apneas, hypopneas and RERA's or respiratory related arousals and/or UARS upper airway resistance syndrome. Ideally snoring should also be resolved. Success should also consider central apneas that are not treated by appliances. If there are substantial episodes of central apnea other alternatives may need to be considered.

Positional treatment and oral appliance therapy are frequently used together if incomplete results are obtained with just an oral appliance. It is important to remember that even patial therapy with an oral appliance is far superior to no therapy in patients who reject CPAP. The physician/dentist should try to eliminate all sleep disordered breating.

Allergies and nasal congestion can be addresses with nasal breathing strips, medication, correction of deviated septums or reduction of turbinates.

Irrigation with a Netti Pot utilizing saline or black tea and saline can reduce mucous congestion. I have seen several patients who clain great relief from NAET, I do not understand or endorse this therapy but I have seen many patients who claim significant relief.

The bottom line, it is essential to control all apneic episodes. Untreated sleep apnea is dangerous and can be fatal. Heart disease, hear attacks, strokes, hypertension, short term memory loss, increased risk of motor vehicl accidents, earlier and more severe onset of dementia and/or Alzheimers are just the tip of the iceberg for possible negative consequences related to sleep apnea.

My advice: See a sleeep apnea dentist with experience and/or a mentor who is trained in multiple oral appliances. I am a Diplomate of the American Academy of Dental Sleep Medicine. There are many dentists who are well trained but have not received Diplomate status. Choosing a Diplomate in dental sleep medicine does insure a wide range of experience but is only one of many considerations.

Problems with TAP 3, What to do?

I am frequently asked questions like the one that follows. There are often many answers to problems. This question is not from one of my patients. I always suggest you discuss all problems with your sleep physician and your dentist.

Question from Phil:
I had been diagnosed with moderate/severe sleep apnea approximately 10 years ago and tried using CPAP as a treatment option. After trying it for a while, I found it to be detrimental to my sleep and noisy both for myself and my wife. Therefore, I first threw the mask off during the night and finally quit alltogether. Since then, I have had multiple back surgeries and a knee replacement which necessitate my taking Advil before sleep in order to eleviate discomfort. I can sleep well most of the time. However, my regular physician recommended that for all of the right reasons, that I have another sleep study done which again confirmed my sleep apnea condition.
As the CPAP and I did not get along the first time, I now chose the 2nd option of an oral device, TAP 3, applied by a certified dentist after fighting with Blue Cross for 11 months before they gave in and agreed to pay. However, the necessary adjustments to allow the desired airflow ha ve proven to hurt my jaw and the long-term side effects can be undesirable as confirmed by my wife as a former dental assistant. What are the thoughts of other users of such a device on the long-term side effects vs. using a CPAP machine which, I understand, have become easier to use since I last tried one?

Dr Shapira Response
Phil,

If you are having jaw pain with the TAP 3 it can be altered occlusally for comfort.(possible posterior stops) More frequently it means you were adjusted forward too fast. You may be able to back it up and bring it forward more slowly. There are long term bite changes and/or tooth movement that are controllable with morning exercises and or retainers.. Studies show no long term joint problems. Approximate 1/2 of patients find changes favorable. Almost all problems are manageable.

It is essential that the apnea be treated. A stroke or heart attack is a lot more serious than a change in bite. Sometimes you can alternate between cpap and applainces. Even though the new CPAP machines and Masks are more comfortable 60% of patients still abandon CPAP treatment.

The Tap 3 can be turned into a TAP-PAP giving you more comfort, lower cpap pressure and less jaw advancement. It can retain your mask with no straps

Most of my patients stay oral appliance therapy long term, though some do alternate with CPAP.

Dr Shapira

Respiratory Care Article Details Problems with CPAP Adherence.

The Respiratory Journal looks at problems related to CPAP adherence. The September 2010 article states "Adverse effects such as nasal congestion, dry mouth, or skin irritation occur in approximately 50% of CPAP users" These side effects are only a few of the problems patients experience that lead to CPAP non-compliance. There are many advances in CPAP treatment that have little effect for most patients on CPAP success. The article states "The use of sophisticated therapy modalities such as auto-titration or bi-level PAP units has been shown to improve adherence in certain subsets of OSA patients" but other research shows little change in CPAP compliance rates. The problems associated with CPAP are the reasons so mmany patients exclaim "I HATE CPAP!".

What kind of patient does not do well with CPAP? The article further states " though a search for consistent predictive factors related to CPAP adherence has proven elusive. Other influences, such as sex, age, socioeconomic status, and personality traits are less robust predictors." In essence all types of patients in every category do not tolerate or adhere to CPAP treatment.

Cpap is a very effective treatment but it is not the best sleep apnea treatment for those patients who do not use it. A recent study showed 60% of patients abandon CPAP. In other words when compliance is factored in the majority of patients are not helped by CPAP'

Dental Sleep Medicine and Oral Appliances may be the best sleep apnea treatment for the majority of patients. Even though they may not be as effective as CPAP they are far more effective than no treatment.

Cardiologists recognize that "the undertreated OSA patient at risk of development or worsening of comorbid medical conditions, including hypertension and cardiovascular disease.". They are also aware of the poor compliance that plagues CPAP.

The concerned and informed cardiologists are now recognizing that CPAP is a dismal failure for the majority of sleep apnea patients and are starting to refer more patients for oral appliance therapy. When patients lives are at stake there must be alternatives to CPAP offered to the patients who do not tolerate CPAP. Regardless of the effectiveness of CPAP it is a worthless treatment if it is not used.

Dental Sleep Medicine offers life-changing alternatives to CPAP to cardiac patients who do not tolerate CPAP.

Respir Care. 2010 Sep;55(9):1230-9.
Encouraging CPAP Adherence: It Is Everyone's Job.
Bollig SM.

Hays Medical Center-Sleep and Neurodiagnostic Institute, 2500 Canterbury Drive, Suite 108, Hays KS 67601. suzanne.bollig@haysmed.com.
Abstract
Obstructive sleep apnea (OSA) is a chronic disease treated effectively with the use of continuous positive airway pressure (CPAP) therapy. Patient adherence to prescribed CPAP is variable, however, leaving . The severity of disease and the presence of daytime sleepiness appear to have some predictive quality for subsequent adherence, though a search for consistent predictive factors related to CPAP adherence has proven elusive. Other influences, such as sex, age, socioeconomic status, and personality traits are less robust predictors. The use of sophisticated therapy modalities such as auto-titration or bi-level PAP units has been shown to improve adherence in certain subsets of OSA patients. Adverse effects such as nasal congestion, dry mouth, or skin irritation occur in approximately 50% of CPAP users, and addressing these adverse effects may improve adherence in some patients. More encouraging, studies on the use of intensive patient education and behavioral interventions have shown more positive effects on adherence, leading to the conclusion that improvement in patient adherence to CPAP therapy requires a multi-layered approach, using combined technological, behavioral, and adverse-effect interventions.

PMID: 20800003 [PubMed - in process]