For Adults and Children
Choking yourself at night has significant health consequences. Obstructive sleep apnoea syndrome (OSAS) is a highly prevalent condition, but it is under-diagnosed and under-managed. It has multiple and far-reaching consequences. The symptom of daytime sleepiness has significant impact on quality of life and productivity, as well as substantially increasing the risk of road and work accidents. Moreover, the condition is very strongly and independently associated with cardiovascular conditions such as hypertension, heart disease and stroke. It is also associated with depression and reduced social functioning.
OSAS is a part of a Syndrome called increased Airways resistance Syndrome or Altered Sleep breathing. Snoring is also a major part of this and also has significant health issues as well as marital issues. The gold standard for management of OSAS is nasal continuous positive airway pressure (nCPAP), which uses a flow of air to increase the air pressure in the upper airway, thereby maintaining its patency. However, a large proportion (~30%) of people is unable or unwilling to use CPAP, and in these cases different options are needed.
Many of these people are successfully treated with oral appliances, or Mandibular Advancement Devices (MADs). However, these devices have some limitations which are listed below.
Sleep Apnoea – A Highly Prevalent, Under-Diagnosed Condition
Obstructive sleep apnoea syndrome (OSAS) is a highly prevalent condition, affecting 4% of adult males and 2% of adult females. It is associated with recurrent episodes of partial or complete upper airway collapse, leading to sleep disturbance and oxygen desaturation. Symptoms include excessive daytime sleepiness, unrefreshing sleep, morning headache and irritability, to name a few.
The World Health Organisation estimates that 100 million people worldwide have sleep-disordered breathing. In the USA sleep-disordered breathing (snorers) is estimated to affect up to 1 in 4 men and 1 in 9 women, and 23 million working adults, but less than 25% of OSAS sufferers have been diagnosed. Moreover, OSAS is growing due to an ageing and increasingly obese population.
The condition is important because of its broad impact on health and well-being. OSAS is strongly and independently associated with cardiovascular conditions including systemic hypertension (High blood pressure), ischemic heart disease (Heart attack) and stroke. It is associated with impaired quality of life, depression and reduced social functioning. Daytime sleepiness and OSAS are also known risk factors for traffic and industrial accidents. Snoring is associated with increased divorce rate, increased blood pressure and cardiovascular disease, not to mention the brunt of many jokes.
Currently it is estimated that only about 10% (or 130,000 patients) of sleep apnoea sufferers in Australia are being diagnosed and effectively treated for their sleep apnoea. Thus more than 1 million Australian sleep apnoea sufferers are probably not getting adequate care for their sleep apnoea. Also 25% of men and 11% of Women snore and they and their partners deserve a good nights sleep. CPAP, the golden Standard has a 30% failure rate.
Gaps In Current Management Options
For patients with significant OSAS, continuous positive airway pressure (CPAP) is usually first line treatment. This is delivered via a nasal/facial mask worn during sleep, connected to a machine that forces air into the upper airway, and thus maintains its patency. However, CPAP is not tolerated by, or may not be suitable for, a significant proportion of sufferers (up to 35%), even if they have severe symptoms. In these cases oral appliances (or MADs – Mandibular Advancement Devices) are a suitable treatment alternative. These appliances usually sit on the upper and lower teeth, with a connection between the two maintaining the lower jaw in a forward position, and preventing it and the soft tissue of the throat from ‘falling back’ and occluding the airway. Oral appliances may also be used in patients with mild to moderate OSA as an alternative to CPAP, failed CPAP sufferers and for CPAP users when they travel.
Although a number of oral appliances are currently available, there are issues associated with the existing appliances:
- The patient’s own teeth act as the anchor for the appliance. Thus, good dentition is generally required, and even when successful, at least half of all users have been documented to experience slight movement of the teeth, potentially creating minor bite changes.
- Individual dental impressions are needed, followed by appliance construction, fitting and adjustment over a series of dental appointments, the time and cost is not insignificant.
- Snorers and sleep apnoea sufferers grind their teeth and this puts increased pressure on their Jaw joints . these can become painful, inflamed and swollen. This inflammation needs to be healed before a final oral dental appliance is fitted or the pain and inflammation can become worse. (Orthopaedic issues) can arise from the pressures exerted on the Jaw Joint or hinge of the Jaw (temporo-mandibular joint -TMJ)
- Importantly, they are anchored to the teeth, meaning that those without teeth are unable to use the normal oral sleep appliances, and need construction of a “special” one.
- Additionally, they are custom fitted and made, and can therefore be costly, often rivalling the cost of a CPAP machine.
Dr Chris Darby (BDSc Melbourne) is the Principal dentist at Lifetime Dental Health Group, practising for 28 years with an established interest in sleep medicine for the last 12 years. He has assisted in the testing program of patients trialling the device (in various embodiments) in the preliminary Proof of Concept stage by utilizing a pharyngometer and/or rhinometer to measure patient airways with and without the device, and fitting and monitoring the devices provided to existing patients. He has used his experience to offer design refinement to improve the acceptance and extend the number of patients who will benefit from the appliance. He will help extend testing to the formal R&D Proof of Concept stage where devices would be made using computer aided Design, Rapid Prototype manufacturing, and existing dental laboratory materials and processes. He is a member of the Australasian Sleep Association, committee member of the Australian Association of Craniofacial Pain (AACP) and accredited Dental Sleep appliance practitioner since 2010. Board of Quiesco – a company who is developing a new, more comfortable Oral Dental Sleep Apnoea and snoring device.
The Process and each visit to a better nights sleep and healthier life.
- The first visit will be a consultation with the dentist to discuss your condition and its severity. We treat all sleep disordered breathing problems from Snoring to Severe Sleep apnoea. Legally we need a diagnosis from a sleep physician to issue you with a Dental Sleep Appliance. As a dentist I cannot diagnose Sleep Apnoea. If you come with your sleep test then we will discuss its consequences, and the options for treatment of your particular condition. Also we will check out the health of your Jaw Joint. To do this we do a Jaw Joint Vibrational Analysis and Structural testing. If your Jaw Joint is inflamed and swollen from night time grinding then the Jaw Joint needs to be healed before issuing a Mandibular Advancement Splint (MAS) . If the new MAs appliance is issued and you have an inflamed jaw joint then the symptoms of Jaw Joint overload can start. Namely, headaches, neck aches, eye aches, ear aches. if you are in pain you will never sleep better. Also we need to check out the patency of your nose. If your nose is blocked most of the time then a MAS is unlikely to help your snoring and sleep apnoea. We have a Rhinometer which can measure the degree of blockage of your nose.
- The second visit is a records visit. We will take upper and lower impressions, and “a bite” that will capture the ideal position of your lower and maximum night-time airway achievable. To determine the “ideal” bite we need 2 X-rays : a lateral Ceph and an OPG.
Technology, Stage Of Development And Competitive Edge:
Quiesco is a company founded by OSA sufferers who have designed a new type of Mandibular Advancement Device which overcomes many of the deficiencies of the current devices.
Whereas existing devices fit totally within the mouth, and comprise upper and lower dental splints connected by a fixed or adjustable coupling, the Quiesco device is internal and external to the mouth. Instead of using the teeth as ‘anchorage’ points, it uses the maxilla and the concave aspect of the mandible, through plates that sit on the skin between the nose and mouth and (ii) inside the mouth below the lower gum line.
The two plates are connected via struts and bite plates which do not rely on the presence of teeth, nor put any pressure on the teeth, but do maintain the relative distance between the upper and lower jaws, thus holding the mandible (lower jaw) and associated tissues in a forward position.
The design allows for modularity and adjustability of the device, so that components can be tailored to individuals’ anatomy and needs, with components selected from a ‘Lego box’ of parts.
Stages of Development
The device has progressed through a number of versions, and is in prototype stage. Devices have been constructed for approximately 6 individual volunteers  (including the founders) by a specialist dental laboratory, and anecdotal evidence from these volunteers has been very encouraging in terms of symptom reduction. No systematic evaluation of the device has yet been conducted.
Further work is required on the design and manufacturing scale-up, particularly in terms of choice of materials, and in specification of the modular components so that the range of components will be suited to the anatomical variations seen in a broader range of patients.
The Quiesco device will share advantages over CPAP with the current oral appliances, such as
- No need for a mask and tubing
- No need for electricity or electronic components
- Portability. Those on CPAP are often left without a solution when they travel away from home
In addition, the device has several advantages over current MADs:
- There is no reliance on the teeth for this device to be effective. Therefore, it is suitable for patients with dentures, and there is no need for dental impressions in order to fit the device
- It should avoid the tooth movement seen in at least half the patients using MADs at 2 years
- It allows the patient to have normal functional motion of the mouth while wearing the device
- Construction using modular components produced in large volumes will avoid the need for dental impressions and bespoke production, thereby significantly lowering the cost of these devices.
Board of The Quiesco device is the invention of GuoPing Yan, one of the founders of Quiesco, and is the subject of a patent application (WO 2006/072147 A1, priority date 10 Jan 2005, assigned to Quiesco Pty Ltd), which has been granted in the US (granted Sept 2010, US 2008/0035157 A1), and is in examination in Europe, Australia, Canada, Japan and other countries.
As mentioned previously, there are a number of oral appliances for sleep apnoea, and the patent literature has many examples of such devices. Indeed, an initial Australian Patent Office review of the PCT application for the device (22 Feb 2006) cited 10 pieces of relevant prior art, and found that there was no novelty in the claims.
However a second review by the same agency (15 Jan 2007) determined in an International Preliminary Report on Patentability that all the claims were novel and inventive. Subsequent examination in Europe has involved amendment of some of the initial claims, but the first 14 claims have remained unchanged.
A need for further treatment options exists, and ideally would have the following features:
- A valid alternative to nasal CPAP (for temporary use e.g. on trips away from home, or on an ongoing basis)
- Non- or minimally-invasive
- Can be used in those whose teeth are not suitable for current oral appliances
- Easy to fit and to use
- Minimal long term adverse sequelae from use
- Cost-effective for payors, healthcare providers and patients
- At least as efficacious as the leading oral appliance on the market