The Luco Hybrid OSA Appliance was developed over a 10 year period with the feedback of two sleep laboratories. The results are very impressive for the sleep studies we have conducted on this appliance to date:
- SO2 levels are restored into the normal range within a few nights.
- REM sleep is quickly restored
- Most markedly, the patients do not mind wearing the appliance!
- Compliance, as checked at one year recall is greater than 94% for nightly wear and 94% over 3 years.
- No TMJ problems after 8 to 10 years of nightly wear
- No periodontal problems, lost fillings or loosening of teeth after 5 years
- This level of compliance ensures the patient receives the maximum therapeutic benefit from the appliance over a long period of time.
- No shifting or tipping of the lower incisors as the cast plate behind these teeth and retainer wire in front securely hold the appliance and the teeth from moving.
- Many patients, at the 3-5 year mark, opt to order a new appliance and retain the old as a spare (should they lose one or similar). Most extended medical insurance carriers in Canada allow replacements at 3-5 years (as well as CPAPs)
This appliance has been successfully used to treat severe non-compliant OSA patients who refused or cannot tolerate CPAP/NPAP therapy. Minimum SAO2 levels can be expected to reach the 93-94% range on severe OSA patients (well above 80%). The American Academy of Sleep Medicine, the Canada Sleep Society, the Canadian Thoracic Society and the Royal College of Dental Surgeons of Ontario also recommend mandibular advancement oral appliances for severe cases that are CPAP failures. The latest research has shown that CPAP compliance is only at 47.5% to 56% and that oral appliances such as this have much higher compliance rates.
The appliance is initially started at protrusive positioning determined by the dentist ordering the appliance. From this initial positioning the appliance is adjustable forward up to 6 mm in 1/4 mm increments. This allows for adjustments over time should a patient gain weight or experience loosening/relaxation of the pharyngeal musculature.
The cast framework is reusable and can last in excess of 20 years. The acrylic is easily replaced by a licensed dental lab inexpensively (around $300-350) every 5 to 6 years, making this appliance unique as it can be used for long-term treatment of OSA patients with one appliance. Because it has acrylic contacting the teeth, it is easily adjusted for new fillings, crowns, etc. whereas some appliances must be remade in these instances. And if the patient accidentally drops it, it does not shatter as others do. Many of our patients, at 3-5 years, order a second appliance and use the first as a spare, for travelling or for their cottage etc.
THE FOLLOWING DATA was collected on 30 patients treated with the Luco Hybrid OSA Appliance in a sleep lab overseen by a certified sleep specialist. All patients were diagnosed with mild to severe obstructive sleep apnea after undergoing an overnight sleep study in a sleep lab. Four patients were severe, CPAP failures. 16 channel polysomnogram was used including pulse oximetry and EMG recordings. They were all tested by the same sleep specialist in the same sleep lab for consistency. Please note cases 0006, 0007, 0021 and 0022 are the severe cases And still showed a significant improvment.
(Please click on a Thumbnail to Enlarge).
APNEA HYPOPNEA INDEX
Apnea Hypopnea Index takes into account both the apnea events as well as the hypoxic events that occurred.
RESPIRATORY DISTRESS INDEX
Respiratory Distress Index includes respiratory-effort arousals(REPAs) as well as apnea events and hypopnea events
SATURATED OXYGEN LEVELS
This measures the amount of dissolved oxygen in the blood in %
SNORING RATE
The following table outlines the reduction in snoring with the Luco Hybrid OSA Appliance
As can be seen in the above tables, the Luco Hybrid OSA Appliance is very effective in treating mild, moderate and some severe obstructive sleep apnea cases. As noted, there have been no TMJ concerns to date and many patients report improved TMJ health, decreased muscle pain and a marked decrease in headaches, both on waking and during the day. Research has shown that OSA appliances are generally capable of reducing the AHI by about 50%. The Luco Hybrid appliance actually has achieved a 75% reduction overall in these studies.
This appliance is FDA market cleared in the US (K130797) for the treatment of mild to moderate OSA and Primary Snoring (as a Class II Medical Device). In Canada, Australia and the EU, it is also registered for the treatment of mild to moderate OSA, primary snoring and in the treatment of Sleep-Related Bruxism. It is clinically proven, very well tolerated by patients and very effective in treatment of the diseases it is cleared for. The appliance is effective, well tolerated and durable, providing a high level of care for the patient they can count on for many years.
If you are interested in this appliance for your OSA patients, please contact the dentists who currently treat your patients and request that they use this appliance in the patient therapy. This appliance is available to any dentist in the USA, Canada and the European Union directly through this company. Once labs become available in the USA, they will be posted on this website allowing dentists in the USA to order directly from these labs.