oral appliances for snoring and obstructive sleep apnea

Oral Appliances for Snoring, UARS and Obstructive Sleep Apnea

Bruce W. Roman, DDS Diplomate, American Board of Orthodontics

Diplomate, American Board of Dental Sleep Medicine

500 SE Douglas Ave…Roseburg, OR…541.672.5721…[email protected]…www.SmilesByRoman.com

© 2014 Bruce W. Roman, DDS, D. ABDSM

What is SDB (Sleep-Disordered Breathing) and how big a problem is it?

SDB includes snoring, Upper Airway Resistance Syndrome (UARS), sleep apnea and the obesity-related hypoventilation syndrome.

Young, et al, in a 2002 article in AJRCCM, Epidemiology of OSA: a population health perspective, concluded:

“SDB is being increasingly recognized as a cause of substantial morbidity and mortality. Approximately 9% of women and 24% of men have SDB and a majority of those remain undiagnosed.”


Pathophysiology of Snoring and Obstructive Sleep Apnea


What is snoring?

Snoring is sound waves caused by vibrations, just as our vocal cords vibrate to form sound waves that we call our voice.


Where do the vibrations come from?

As you fall asleep, the soft tissues at the back of the throat, the muscles that line the airway, the soft palate, uvula and the tongue, relax.

The tongue then drops back into the airway, causing it to narrow.

As air passes through this narrower airway, it moves faster and causes the tissues to vibrate.


Is snoring really a problem?

• Just ask the bed partner…they’ll tell you!!!

• 27-31% of all married couples sleep in separate rooms with snoring being a principal reason.

• With loud snoring, even other household members can be effected. And they don’t like it any more than the bed partner.

Bed Partners’ and Patients’ Experiences after Treatment of OSA with an Oral Appliance; Tegelberg, et al., Swed Dent J 2012:

• Both patients and bed partners reported improvement in general well-being, physical strength and mental energy (70-80% for patients; 55-68% for bed partners).”

• Conclusions: “In all dimensions, the treatment effect had a great influence, not only on patients but on bed partners as well.”



What about “heavy” snoring?

A study published in the September, 2008 issue of SLEEP, Heavy Snoring as a Cause of Carotid Artery Atherosclerosis, concluded:

“Heavy snoring (defined as more than 50% of the night) significantly increases the risk of carotid atherosclerosis (“hardening of the arteries”), and the increase is independent of other risk factors.”


What is UARS? • Upper Airway Resistance Syndrome (UARS) is a sleep

condition in which there is airway resistance to breathing. Breathing becomes labored. It is similar to trying to breathe through a thin straw.

• The increased upper airway resistance in UARS does not lead to a stoppage of airflow (apnea) or decrease in airflow (hypopnea), but instead leads to an arousal due to the increased work of breathing to overcome the resistance. Repeated and multiple arousals (which the patient is usually unaware of) result in fragmented and non-restorative sleep.

• The primary UARS symptoms include snoring, daytime sleepiness and excessive fatigue.


What is Sleep Apnea?

There are three types of sleep apnea:

1) Central

2) Obstructive

3) Complex or Mixed


Central Sleep Apnea

Central sleep apnea occurs when the brain fails to send the appropriate signals to the breathing muscles to initiate respirations.


Obstructive Sleep Apnea

Obstructive sleep apnea (OSA) is a sleep-related breathing disorder that involves a RERA (respiratory effort-related arousal), decrease (hypopnea) or complete halt (apnea) in breathing despite an ongoing effort to breathe.


Complex or Mixed Sleep Apnea

Mixed sleep apnea is a combination of both central sleep apnea and obstructive sleep apnea.


• If your oxygen level drops low enough—and if you are experiencing an apnea, it will—your brain sends a signal to the muscles in the airway to contract.

• The airway opens—usually accompanied by a loud gasp—and air flows again.

• Then the cycle starts again.


Why be concerned about sleep apnea?

The combination of low oxygen levels and broken sleep cause one or more of the symptoms associated with sleep apnea:

1) Excessive daytime sleepiness

2) Snoring

3) Cardiovascular disease (“heart attack”)

4) Cerebrovascular disease (“stroke”)

5) Brain damage


In the May, 2009 issue of the Journal of the American Dental Association, Simmons & Clark, in an article entitled, The potentially harmful medical consequences of untreated sleep-disordered breathing, concluded:

“The evidence suggests that EH [Episodic Hypoxia], as seen in SDB, causes damage to the brain…and damage to higher cognitive [thinking] functions.”


6) High blood pressure (hypertension)

7) Diabetes

8) Depression

9) Decreased sex drive and impotence

10) Morning headaches

11) Poor memory and clouded thinking

12) Personality changes and irritability

13) Restless sleep


14) Increased health care costs

15) GERD (Gastroesophageal Reflux Disease)

16) 10-15X more likely to have a motor

vehicle accident:

– 0 hours of sleep = .195% blood alcohol level reaction time




17) Loss of employment

18) Marital discord

19) Bruxism

Neurology of Sleep and Sleep-Related Breathing Disorders and Their Relationships to Sleep Bruxism, Simmons, JCDA; 2012 Feb;40(2):159-167

“Recent research by Simmons and Prehn has demonstrated that SB or clenching may occur as a mechanism to prevent airway collapse. Their studies demonstrated that during the SB process there is a reduction of negative pressures of the upper airway…When the SB process is not present, there is an increase in airway obstruction.”


Effect of an Adjustable Mandibular Advancement Appliance on Sleep Bruxism: A Crossover Sleep Laboratory Study; Shönbeck, et al., Intl J Prosthodontics, May-Jun 2009; 22(3):251-259

Results: The mean number of SB episodes/hr was reduced by 39% and 47% from baseline with the MAA at a protrusion of 25% and 75%, respectively.

Conclusion: Short-term use of an MAA is associated with a significant reduction in SB motor activity without any appliance breakage. A reinforced MAA design may be an alternative for patients with concomitant tooth grinding and snoring or apnea during sleep.



20) Increased mortality rate, especially for men.

Dr. Naresh Punjabi (John Hopkins) and nine other researchers examined 6,441 men and women. (Sleep-Disordered Breathing and Mortality: A Prospective Cohort Study; PLoS Medicine, August, 2009).

Findings:

• Participants with severe SDB (an AHI of ≥ 30) were about one and a half times as likely to die from any cause after adjustment for potential confounding factors.

• In subgroups according to age and sex, men aged 40-70 years with severe SDB had twice the risk of dying as men of a similar age without SDB.


21) CANCER!

Sleep disordered breathing and cancer mortality: results from the Wisconsin Sleep Cohort Study, Nieto, et al, AJRCCM, May 20, 2012:

“Compared to normal subjects, the adjusted relative hazards of cancer mortality were 1.1 for mild SDB, 2.0 for moderate SDB, and 4.8 for severe SDB.”


Measuring Sleep Apnea

AHI (Apnea-Hypopnea Index): The number of apneas and hypopneas that occur per hour.

Mild: ≥ 5 and < 15 events/hr

Moderate: ≥ 15 and ≤ 30 events/hr

Severe: > 30 events/hr

Pediatric OSA

• Frequently overlooked as a problem. • Child often becomes overactive, rather than

sleepy. Some become hyperactive and are diagnosed ADHD.

• Symptoms include: 1) Restless sleep; 2) Loud snoring; 3) Nightmares; 4) Morning headaches; 5) Behavioral problems; 6) Bedwetting; 7) Gets tired easily; 8) Wakes up tired; 9) Concentration problems; 10) Is irritated.

• Most common causes: 1) Enlarged tonsils and adenoids; 2) Narrow maxilla; 3) Obesity.


Grading Tonsils



When are Oral Appliances (OA’s) indicated?

In the AASM (American Academy of Sleep Medicine) report in the February, 2006 issue of SLEEP, Practice Parameters for the Treatment of Snoring and Obstructive Sleep Apnea with Oral Appliances: An Update for 2005, it states:


1) OAs are appropriate for use in patients with primary snoring who do not respond to or are not appropriate candidates for treatment with behavioral measures such as weight loss or sleep-position change.


2) Although not as efficacious as CPAP, OAs are indicated for use in patients with mild or moderate OSA who prefer OAs to CPAP, or who do not respond to CPAP, are not appropriate candidates for CPAP, or who fail treatment attempts with CPAP or treatment with behavioral measures such as weight loss or sleep-position change.


3) Reviewed studies of patients with severe OSA demonstrated treatment success (variably defined) with OAs on an average of 34.3% ± 13.5%...CPAP is indicated whenever possible for patients with severe OSA before considering OAs.

A December, 2011 study in Chest, “Efficacy of an Adjustable Oral Appliance and Comparison with CPAP for the treatment of OSAS, found…

“In comparison to past reports, more patients in our study achieved an AHI < 5 using an aOA (adjustable oral appliance). The aOA is comparable to CPAP for patients with mild disease, whereas CPAP is superior for patients with moderate to severe disease.”



Journal of Clinical Medicine Special Article of March, 2009: Clinical Guide for the Evaluation,

Management and Long-term Care of OSA in Adults

Some key points:

● Once the diagnosis is established, the patient should be included in deciding

an appropriate treatment strategy that may include PAP devices, OAs, behavioral treatments, surgery, and/or adjunctive treatments.

● CPAP is the treatment of choice for mild, moderate, and severe OSA and

should be offered as an option to all patients. Alternative therapies may be offered depending upon the severity of the OSA and the patient’s anatomy, risk factors, and preferences and should be discussed in detail.

● If CPAP use is considered inadequate based on objective monitoring and

symptom evaluation, prompt and intensive efforts should be implemented to improve PAP use or consider alternative therapies.


Appliance Therapy vs. nCPAP in OSA; Respiration, Oct. 2010

The article looked at carefully controlled studies in which both CPAP and OAs were carefully titrated (adjusted).

Conclusion: There is no clinically relevant difference between a MAD [Mandibular Advancement Device] and nCPAP in the treatment of mild/moderate OSA when both treatment modalities are titrated [adjusted] objectively.


How do you “titrate objectively”?

• After the patient is comfortable with the appliance, additional advancement is slowly introduced.

• While this is occurring, subjective reports and tests (e.g., Epworth Sleepiness Scale) are used to assess progress.

• Once subjective relief of symptoms is achieved or the limit of what the TMJs and/or musculature will allow is reached, a sleep test is needed to quantify results.

• If indicated, we use the Medibyte portable home sleep test monitor to quantify results before referring the patient back to their primary care physician or sleep physician for whatever sleep test they deem necessary.


MediByte® (Home Sleep Test Portable Monitor)


MediByte® Highlights

● It is the smallest Type 3 recorder in the world at 3 x 2.8 x .75 inches. Weighs 3.3 ounces.

● It can record up to 12 channels and exceeds the new AASM guidelines.

● On-board pulse oxyimetry, pressure and body position sensors eliminate external transducers.


Other indications for an OA: 1) Use in travel or camping

2) In combination with CPAP:

a) Can advance mandible which allows patient to reduce CPAP pressure—increasing compliance

b) No mask or headgear connected to nasal pillows

c) Mouth closed so no air will escape (ideal for patients who tend to open mouth with CPAP)


What about Medicare?

• Custom oral appliances are covered under Durable Medical Equipment, not Medicare Part B.

• Most dentists, if they accept Medicare at all, are non-participating DMEPOS suppliers.

● Medicare, including supplemental insurance, will, on average, reimburse $1321.60. However…


Medicare issued the following on July 5, 2012:

Custom fabricated mandibular advancement devices must meet all of the criteria below:

1) Have a fixed mechanical hinge (defined as a mechanical joint containing an inseparable pivot point).

2) Require no return dental visits beyond the initial 90-day fitting and adjustment period to perform ongoing modification and adjustments in order to maintain effectiveness…Items that require adjustments beyond the initial 90-day period are not eligible for classification as DME. These items are considered as dental therapies, which are not eligible for reimbursement by Medicare under the DME benefit. (Effective November 1, 2012?)


Medicare Limitations of Coverage and/or Medical Necessity

The patient must have a Medicare-covered sleep test within the last 3 years that meets either of the following criteria (1 or 2):

1) The AHI or RDI is ≥ 15 (moderate or severe sleep apnea) or, 2) The AHI or RDI ≥ 5 and ≤ 14 (mild sleep apnea) with a

minimum of 10 events and documentation of:

– a) Excessive daytime sleepiness, impaired cognition, mood disorders, or insomnia, or,

– b) Hypertension, ischemic heart disease, or history of stroke.


Types of Oral Appliances:

1) Mandibular advancement or repositioning appliances (or splints or devices)

2) Tongue retaining devices


Medicare Comment Summary of Nov. 11, 2010:

Comment: There are no randomized, controlled crossover trials that show efficacy of any prefabricated [“boil & bite”] OA. As the literature only supports the use of custom appliances, we urge the complete removal of the paragraph giving preference to E0485 [prefabricated or “boil & bite” appliances].

Response: Agree. Because of the lack of proven efficacy, prefabricated appliances will be denied as not reasonable and necessary.


In an excellent study entitled Comparison of a Custom-made and a Thermoplastic Oral Appliance for the Treatment of Mild Sleep Apnea, Vanderveken, et al

concluded:

“In this study, a custom-made device turned out to be more effective than a thermoplastic device in the treatment of SDB. Our results suggest that the thermoplastic [“boil & bite”] device cannot be recommended as a therapeutic option nor can it be used as a screening tool to find good candidates for mandibular advancement therapy.”


Custom Oral Appliances SomnoDent G2 Flex


Adjustable PM Positioner (APM Ultra)


Elastic Mandibular Advancement (EMA)


SUAD Device


TAP 3


SomnoDent Herbst Appliance


Silent Nite


Full Breath Solution Lower


FBSL with a very small Tail


Mallampati 4 – Closed Airway


Another lateral head x-ray before appliance insertion.


The left image below is a three dimensional reconstruction of a patient’s airway without a MAD. The right image is an image with a MAD properly positioned in the mouth.


Tongue Retaining Devices

aveoTSD


[Original] Tongue Retaining Device


Evaluation for an Oral Appliance:

Sleep Test Review

The American Academy of Sleep Medicine Clinical Guidelines states:

“The severity of OSA must be established in order to make an appropriate treatment decision. No clinical model is recommended to predict severity of obstructive sleep apnea, therefore objective testing is required. A diagnosis of OSA must be established by an acceptable method (Standard). The two accepted methods of objective testing are in-laboratory polysomnography (PSG) and home testing with portable monitors (PM).”

• Chief Complaint addressed and OA discussion and information

• Dental examination

• Periodontal examination

• TMJ examination



After suitability is established…

1) Diagnostic records: Study models, panoramic or full-mouth x-rays, cephalometric (head) x-ray (if indicated), photographs.

2) Impressions for appliance fabrication and a George Gauge bite registration.


George Gauge Bite Registration


Delivering the Oral Appliance

• Once the appliance is received from the dental lab, it is tried in and adjusted.

• Directions for its use and care are given.

• A normal activation schedule is 1-2 turns every 3-4 days, while monitoring and adjusting that schedule depending upon side effects.


How Long Does it Take?

• Usually results are noticed from the next morning to two weeks. Snoring and excessive daytime sleepiness decrease. Bed partners are very happy.

• Over the period of a few months, maximum/ideal advancement is achieved. However, it can take up to 6 months for swelling in the throat tissues to be eliminated. Home sleep tests may be used in the interim or even as the final sleep test, depending upon the desires of the sleep physician.


What is the Dental Team’s Role?

SCREENING--especially before:

● Placing a TMD orthotic.

● Removing teeth that would reduce tongue space and/or “eliminate” the possibility of surgery to advance the mandible to open up the airway.


Aggravation of Respiratory Disturbances by the Use of an Occlusal Splint in Apneic Patients: A Pilot Study (Gagnon, et al., Int J Prosthodont 2004;17:447-453)

• Results: The AHI was increased by more than 50% in 5 of the 10 patients. The percentage of sleeping time with snoring also increased by 40% with the splint.

• Conclusions: …study suggested that the use of an occlusal splint is associated with the aggravation of respiratory disturbances. It may therefore be relevant for clinicians to question patients about snoring and sleep apnea when recommending an occlusal splint.


Screening 201

Have patient complete an Epworth Sleepiness Scale*. If 9 or higher, refer to PCP.

Note: Males tend to significantly under report. Much better to have the bed partner fill it out.

* The ESS was not designed for sleep apnea screening but is the most widely used questionnaire. The Berlin Questionnaire (see web site) was designed specifically as a screening tool, but is more complicated/timely to score.


Possible Complications and Side Effects of OA’s


Dental side effects of an oral device to treat snoring & OSA, Sleep, March, 1999, Pantin, et al.:

• Excess salivation (30%)

• TMJ pain (27%)

• Dental discomfort (27%)

• Muscle discomfort (25%)

• Dry mouth (23%)

• Bite changes (12%)

• TMJ noises (7%)


“Five Years of Sleep Apnea Treatment with a MAD”, January, 2010, Angle Orthodontist

Conclusions:

1) Five-year oral appliance treatment does not affect TMD [“TMJ”] prevalence.

2) Is associated with permanent occlusal changes in most sleep apnea patients during the first 2 years. However, this tendency reversed 2 years to 5 years.


Craniofacial Changes After 2 Years of nCPAP Use in Patients with OSA (Tsuda, et al.; Chest; Oct. 2010)

Results: 1) significant retrusion of the anterior maxilla; 2) setback of the supramentale and chin positions; 3) retroclination of the maxillary incisors. (However, none of the patients self-reported any permanent change of occlusion or facial profile).

Bottom Line: There’s no free lunch with either nCPAP or OAs. But treatment of OSA is far more important with either modality than no treatment in comparison to mostly minor or insignificant changes with both.


What about weight loss? Effects of dietary weight loss on OSA: a meta-analysis, Anandam, et al., Sleep Breath, February 29, 2012, concluded: Dietary weight loss programs are effective in reducing the severity of OSA but not adequate in relieving all respiratory events. Weight reduction programs should be considered as adjunct rather than curative therapy.

They also found: • Patients with mild OSA who gain 10% of body weight are at a 6X

risk of progressing to a higher OSA severity. • An increase of 10% over time increases the AHI, on average, by

30%.

• A 10-15% reduction in body weight can reduce the AHI by 50%.


Are there any exercises for patients with OSA?

Puhan, et al., in a December, 2005 article in the British Medical Journal, Didgeridoo playing as an alternative treatment for OSA, showed that regular playing (6 days/wk, 25 mins/day for 4 months), reduced the average AHI by almost 50% (22.3 to 11.6) and lowered the ESS score from 11.8 to 7.4


Note: If using for sleep apnea therapy, the headpiece is optional.


Clinical Asst Professor of Medicine, Univ of AZ, Rubin Naiman, Ph. D., says: “Learning to play the didgeridoo is emerging as a surprisingly effective and practical strategy

for managing snoring and sleep apnea patients.”

oral appliances for snoring and obstructive sleep apnea

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