Ask The Expert. Apnicure’s Chief Scientist Officer, David White
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It is a constant effort to find more effective and comfortable sleep apnea treatment options. Dr. David White is widely regarded as the leading expert in sleep apnea treatments. He is currently the chief medical office at a major manufacturer of sleeping apnea treatment products. We spoke to him about the latest developments in the field and the technologies that are being developed to improve patients’ lives.
What scientific breakthroughs have you seen in sleep apnea treatment and diagnosis?
Since long time, there has not been a significant change in how sleep apnea diagnosis is done. Although the methods used are not new in their use, the desire to diagnose and treat sleep apnea has increased steadily based on increasing evidence that OSA can lead to adverse cardiovascular outcomes such as strokes, heart attacks and death. There are no randomized controlled trials that have shown OSA treatment leads to better cardiovascular outcomes.
In the same way, there have not been any new treatments in OSA treatment in the past 10-20 years. CPAP devices are smaller, quieter and better humidified than those made in 1980. However, they work in a similar way to the 1980s.
The CPAP masks, on the other hand are much better than before and could be responsible for some of the small gains in CPAP compliance over the past few decades. The mandible has also been improved by dental appliances, although they are still a minor improvement. OSA treatment is generally successful with some success. The upper airway surgical procedures are also evolving. However, unless it is a major procedure, the chances of success are low and only a few such procedures are performed annually in the US. There are new treatments that might offer apnea patients more options.
Are there any new treatments on the horizon for cancer?These therapies will continue to improve and be accepted with greater adherence. However, they will not lead to breakthroughs or significant improvements. These are the new therapies, which were either just released or are currently in clinical trials:
ProventThis disposable device consists of a valve that is placed on each nostril. It has a low inspiratory resistance but a high expiratory resistance (50cm H20). This results in an increase in lung volume and high positive pressure during expiration, which dilated the airway.
Although this therapy has been around for a while, it has not gained much traction. This may be due to its limited effectiveness and the pain many patients experience when using it. Provent is unlikely to be widely used.
Genioglossal stimulation(Inspire): Several companies were creating devices that stimulated the genioglossus muscles to maintain the pharyngeal open during sleep. A failed clinical trial led to the closure of one company, Apnex. Inspire is the last company to be seen, and is close to completion of its FDA trial. The device stimulates the genioglossus unilaterally using a pressure sensor between the intercostal muscles. Their current clinical trial does NOT include patients who are morbidly obese. It requires a sleep endoscopy (airway visualization with anesthesia) before the procedure. This is to ensure that the area/level of collapse is appropriate for this therapeutic approach. As the trial data have not been published, I believe that this therapy may work in some patients and be acceptable for a small number of OSA patients. It is expensive, however, with the stimulator costing around -20,000. This price does not include the sleep endoscopy or any follow up care (including sleep study). This means that this treatment will likely cost between -40,000 and -40,000 per patient. This will result in insurance companies restricting access to the procedure. It will not be widely used to replace CPAP for millions of patients who receive it annually.
Winx(Apnicure:) The Winx device is composed of a console that creates negative pressure, and a mouthpiece that applies this pressure to the oral airway. The device works by pushing the soft palate and the uvula forward against your tongue base. In some cases, it may also pull the tongue forward slightly. This opens up the pharyngeal area to allow unobstructed sleep. This device has been the subject of one major study, and it was published in Sleep Medicine. It reduced the apneahypopnea index (AHI), by more than 50%, and gave rise to an AHI20 in approximately 41% of patients. Patients who were successfully treated had an AHI.
PhenotypingThis is not a treatment. It’s a way to approach OSA patients that could lead to new treatments. OSA patients develop it for many different reasons. There are four main physiologic traits that determine who has OSA and who doesn’t. These are:
- Collapsibility/anatomy of the upper airway.
- The upper airway response to sleep is the pharyngeal muscle responsiveness of the pharyngeal dilation musclesThese muscles are able to activate and dilate your airway while you sleep.
The physician can determine the exact reason each patient has OSA. Therapy could then be targeted at that specific abnormality (from the above list). This could lead to a variety of new therapies that are tailored to the individual needs of each patient. Some examples would be:
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- If the arousal threshold for hypnotics is low, they might still be effective.
- If loop gain is excessive, oxygen or acetazolamid could be used to reduce it
Other therapies that I know of are currently in development include:
Implantable surgical devicesOver the past 5-10 years, several start-ups have tried to create a surgically implantable device that is primarily used to adjust the tongue’s position. These devices would attach to the mandible using a type anchor in the body. This allows the tongue to be pulled forward from the pharyngeal area. These devices were tested in clinical trials with promising results. The materials used for these trials were not strong enough to withstand constant tongue movement, breakage of prongs, and slippage of the tethers. They will need to be further developed before they can be used successfully. The concept is sound, however.
Apnea therapy can be pharmacologically treatedMany trials of various pharmacologic drugs have been conducted over the years in OSA patients, with little or no success. At this point, there are no visible trials or active research by pharmaceutical companies to create a drug for OSA. This could change as we gain more knowledge about the neurobiology and brainstem control of the OSA pharyngeal muscles.
What is special and compelling about Apnicure from your perspective?
Apnicure believes that it has a product that can be used to treat OSA patients (about 40%-50%) with a device that is more comfortable, quieter and more acceptable for these patients. The device’s effectiveness can also be improved, according to our opinion. Our goal is to develop a well-tolerated and highly effective treatment for OSA.
RLS News article for Sleepfoundation.org
RLS Patients Surveyed
The Willis-Ekbom Disease Foundation, and XenoPort, Inc. conducted a survey among patients with Restless Legs Syndrome (RLS) and found that two-thirds (68%) of them strongly believed doctors needed to be more educated about the condition. Three quarters of patients (73%) report that they experience symptoms every day and only 6% feel their symptoms can be controlled with their current medications. Nearly all (93%) of patients surveyed said they would like to see more effective medication for RLS.
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