The Luco Hybrid OSA Appliance is classified as a mandibular advancement type appliance as it holds the lower jaw in a forward positioning. This also moves the tongue forward, stabilizing the airway.
With sleep apnea, the tongue falls back and the throat muscles relax blocking the airway (Figure 1):
Mandibular advancement appliances all work by moving the lower jaw forward and holding it there. This prevents the tongue from blocking the airway.
The Luco Hybrid is FDA cleared for the treatment of sleep apnea and snoring. This is not a unique feature as all sleep apnea appliances work the same with this regard.
THE PATENTED FORWARD BITE
What does make the Luco Hybrid different is how it also treats sleep bruxism and associated tension/migraine headaches. This is how it accomplishes this:
The Luco Hybrid has a patented forward bite that affects a series of reflexes in the jaws. It also provides a very even stress distribution through the skull. The following animation demonstrates the unfavorable stress distribution when biting in the molar region (Figure 2):
The Molar Bite
In this animation, you can see there are areas marked in red These include the body of the lower jaw, the ramus or verticle part, the condyle or ball portion and, most importantly, the TMJ or jaw joint. There are areas marked in red under the eye and there is stress radiating down the nasal septum (which can lead to a deviated septum in some). The Luco Hybrid is the only OSA or TMJ appliance that does not use this type of bite.
After years of research, the bite was shifted forward to the region of the eyetooth and 1st bicuspid. This provides a much more favorable stress distribution, as seen in this animation (Figure 3):
The Cuspid Bite
As can be seen in this animation, the only area marked in red is the tip of the eyetooth, all other areas demonstrate lower stress. The bite in this area is evenly distributed up the facial bones and over the skull. There is no stress distribution to the TMJ region. The Luco Hybrid is the only OSA/TMJ appliance with this bite.
The Luco Hybrid’s forward bite is unique and patented (protected under US patent 9,545,332 B2). This forward bite reduces the bite force by preventing the sleep bruxism events via activation of the periodontal-masseter reflex of the cuspids. resulting in relaxation of the jaw muscles. Tension/migraine headaches are significantly reduced or eliminated. The Luco Hybrid is the first FDA cleared treatment of sleep bruxism and associated tension/migraine headaches. To date, it is the only FDA cleared of sleep bruxism of any kind.
THE TRIGEMINO-CARDIAC REFLEX (TCR)
This reflex is best known for its effect on scuba divers. When the face is placed in cold water, heart rate, breathing, and blood pressure are reduced. This reflex is also seen in marine mammals like whales and dolphins. It is an oxygen conserving reflex and very helpful for marine mammals. It is activated in 6 regions of the face:
- The nasal mucosa (inside the nose)
- The eyeball
- The upper and lower jaws
- The Gasserion (trigeminal) ganglion
- Central (after the ganglion)
- The brainstem
Figure 4 Stimulation of the TCR at the Gasserion Ganglion by Sleep Bruxism.
All regions except the Gasserion gangion result in the slowing of heart rate and breathing and lowering of the blood pressure. When stimulated at the Gasserion ganglion (Figure 4), there is the opposite effect: an increase of heart rate, breathing and raising of the blood pressure. Sleep bruxism affects the TCR at this level. An increase in heart rate is a hallmark sign of sleep bruxism!
By definition, tachycardia is a heart rate in excess of 90 beats per minute. The sleep tracing in Figure 5 demonstrates a patient with sleep bruxism. You can see that breathing is disturbed and the heart rate increased from 62 bpm to 111 bpm, an increase of 79%! This meets the medically accepted criteria of a 20% change in heart rate required to make a diagnosis of TCR activation. It also indicates that sleep bruxism has a profound effect on the TCR as it far exceeds this 20% threshold.
The tracing below (Figure 6) is the same patient wearing the Luco Hybrid device:
Notice the difference between Figures 5 and 6? In figure 6 there are no sleep bruxism events, breathing is steady and normal and the heart rate is steady between 72 and 75 bpm (4% increase). This demonstrates very clearly how the Luco Hybrid device treats sleep bruxism and prevents activation of the TCR. Heart rate is reduced to normal levels reducing stress on the heart. The Luco Hybrid returns heart rate well below the 20% threshold, indicating it is preventing activation of the TCR.
This is what makes the Luco Hybrid truly unique in mandibular advancement therapy. This effect is seen in patients suffering from sleep apnea, snoring, sleep bruxism and tension/migraine headaches and any combination of these conditions.
The patented forward bite is a very significant feature of this device as is instrumental in providing even stress distribution as well as decreasing or eliminating the sleep bruxism events and the associated activation of the TCR.
It is the only OSA appliance that may be safely used on patients suffering from sleep apnea/snoring who also suffer from sleep bruxism. It is also the only OSA appliance that safely reduces the muscle pain associated with TMD more than a few months.
With the way this advanced medical/dental devices works, it restores deep, restorative sleep within the first few nights. The stabilization of the airway and tongue promote effortless airflow allowing the patient to drop into deep sleep.
Figure 7 shows a typical hypnogram or graphic representation of a night sleep. It is broken down by stages of sleep, numbered 1 to 4 and REM sleep. The blue bar indicates the stages where sleep bruxism occurs.
It should be noted that when we sleep, we cycle through the stages of sleep, as in the diagram. REM sleep starts as a short burst and increases with each cycle of sleep. There are 4-5 sleep cycles each night. In the last cycle, before waking, REM sleep can last as long as 15-30 minutes in length. With sleep remaining in stages 1 and 2, deep restorative sleep is not reached.
Sleep bruxism occurs primarily is stages 1 and 2 (blue bar) but can also be seen in REM sleep. Each sleep bruxism event (and there can be hundreds in a night) results in a sleep arousal, conveying the patient from deeper sleep into shallower sleep. Over time, this results in sleep deprivation and daytime sleepiness or tiredness. There are many health problems associated with sleep deprivation.
The Luco Hybrid device reduces considerably the number and intensity of the sleep bruxism events resulting in restoration of deep restorative sleep, usually in the first night or two. Within a few weeks, the sleep bruxism is well controlled and, as long as the device is worn during sleep, the condition is controlled.