Untreated obstructive sleep apnea carries significant morbidity and mortality and has evolved into a public health problem, yet effective treatment remains elusive for many patients. Surgical treatments, oral applications, and the current gold standard treatment with continuous positive airway pressure (CPAP) work for some patients, but data indicate that up to 50% of patients are not successfully treated with these methods.
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August 2009Part of the difficulty in developing an effective nonsurgical treatment is not the treatment itself, but the appropriate application and use of the treatment. What is highlighted by the current data on the efficacy of CPAP is that a treatment itself can confer a high degree of effectiveness, but if the patient does not use the treatment appropriately, its efficacy is compromised.
Philip Westbrook, MD, Emeritus Professor of Medicine at UCLA and Chief Medical Officer of Ventus Medical, Inc., in Belmont, CA, emphasized this point in discussing the need to develop alternative treatments. It is really the patient that treats the disease in chronic disease, he said. Because of that, if we prescribe a treatment that the patient won’t use, than that treatment is ineffective no matter how good it looks in the laboratory.
For a chronic condition such as sleep apnea, developing treatments that are effective in addressing the mechanism of disease as well as patient compliance requires both a deep knowledge of the pathophysiology of sleep apnea and the anatomy of the upper airway and an understanding of human psychology and behavior.
This is not a new idea, but one that underlies the development of two new therapies that have emerged to treat sleep apnea and will be applied to measuring the efficacy of these treatments.
PROVENT Therapy
PROVENT therapy (Ventus Medical, Inc.) is one emerging alternative to the therapies currently used to treat sleep apnea. Unlike CPAP, which requires a machine to provide continuous positive airway to keep the nasal airway open during sleep, PROVENT therapy relies on the patient’s own breathing to keep the nasal airway open by using a device that uses nasal expiratory positive airway pressure (EPAP). Placed on each nostril, the device acts like a valve (and looks and feels like a small bandage on each nostril, according to Dr. Westbrook). The valves are open when inhaling to allow for nearly unobstructive airflow, but close when exhaling, directing air through small air channels to limit airflow and increase expiratory pressure.
I have been very impressed by the approach of Ventus Medical, the makers of the PROVENT, to perform research to understand why and in whom the device works well before they rush it out and just start selling it. This will be critical in helping providers understand to whom they should prescribe the devices as well as helping to support third-party reimbursement.
-Eric J. Kezirian, MD, MPH
Recent results of pooled data from two trials that examined the efficacy of PROVENT therapy showed that the therapy was effective in 72% of 58 patients, as measured by achieving an apnea-hypopnea index (AHI) of ≤10 or AHI improved by at least 50% (Westbrook et al. Success rates of nasal expiratory positive airway pressure [nEPAP] via expiratory resistive load for the treatment of obstructive sleep apnea. Abstract 0570. Sleep 2009, Seattle, WA).
According to Dr. Westbrook, these results are comparable with those obtained through surgery or oral appliances, but without the upfront costs. But a key question is compliance. Will patients use this device?
Like CPAP, you have to get used to it, said Dr. Westbrook. There is an acclimatization that must take place to get used to it, usually one to seven days for most patients.
Data from a small 30-day study of 28 patients who used PROVENT therapy suggest good compliance, according to Dr. Westbrook. In that study (Colrain IM et al. J Clin Sleep Med 2008;4:426-33), 94% of the patients used PROVENT therapy throughout the night.
Dr. Westbrook emphasized that more accurate data on compliance will emerge with results of an ongoing longer-term trial that includes 250 patients randomized to EPAP (PROVENT therapy) or sham EPAP. But he suspects that compliance will be very good, based on the portability and simplicity of the device. You can carry a month’s supply in your pocket, it is disposable, and it doesn’t require an outlet, tubes, or a mask, he emphasized.
I may not recommend [EPAP] for every night, but it may be a good alternative, for example, for patients who are on hunting or fishing trips where there is no electricity.
-Pell Ann Wardrop, MD
For Pell Ann Wardrop, MD, Chair of the Sleep Disorders Committee of the American Academy of Otolaryngology-Head and Neck Surgery, the portability of this device makes it an attractive alternative, particularly in specific situations. I may not recommend it for every night, but it may be a good alternative, for example, for patients who are on hunting or fishing trips where there is no electricity, she said.
One issue that may curb the use of this device, at least in the near future, is the lack of insurance coverage until there are specific billing codes for the device, according to Eric J. Kezirian, MD, MPH, Director of the Division of Sleep Surgery in the Department of Otolaryngology-Head and Neck Surgery at the University of California, San Francisco. Dr. Kezirian, however, admired the way in which PROVENT therapy has been developed and marketed. I have been very impressed by the approach of Ventus Medical, the makers of the PROVENT, to perform research to understand why and in whom the device works well before they rush it out and just start selling it, he said. This will be critical in helping providers understand to whom they should prescribe the devices as well as helping to support third-party reimbursement.
Currently, PROVENT therapy is available in limited markets to sleep specialists. It is indicated for patients with moderate to severe sleep apnea, but contraindicated for certain populations, such as children and other patients with anatomical abnormalities that are best treated surgically.
Dr. Westbrook, who suggested that otolaryngologists consider this therapy as a reasonable first-line therapy for some patients, also emphasized that otolaryngologists recognize the harm surgery may do in decreasing the efficacy of treatments such as CPAP and EPAP. Although he said that the evidence to date is speculative on this, he urged otolaryngologists to become familiar with the data. He also suggested that there may be a role for a combination of surgery and EPAP, but again emphasized that this was speculative.
Oropharyngeal Exercises
Exercises that strengthen and tone the oropharyngeal muscles comprise another treatment approach that is gaining some traction. Evidence supporting this emerged previously in studies that showed the efficacy of playing the didgeridoo, an Australian musical instrument, in reducing symptoms of sleep apnea (Burkhead et al. Dysphagia 2007;22:251-65).
More recent data come from a randomized trial of 31 patients with moderate obstructive sleep apnea treated by exercises involving the tongue, soft palate, and lateral pharyngeal wall (Guimaraes KC et al. Am J Respir Crit Care Med 2009;179: 962-6). Developed by a speech therapist, the exercises include functions of suction, swallowing, chewing, breathing, and speech. The study found that patients treated with exercises had a significant reduction in severity and symptoms of obstructive sleep apnea compared with a control group as measured by a significant decrease in neck circumference, snoring frequency and intensity, daytime sleepiness, sleep quality score, and AHI.
According to senior author Geraldo Lorenzi Filho, MD, PhD, of the Sleep Laboratory in the Pulmonary Division, Heart Institute (InCor) at the University of Sao Paulo Medical School, the results showed a 40% reduction of apnea severity and symptoms. Emphasizing that this treatment approach is only for patients with moderate sleep apnea, and not for severe apnea, he also emphasized the importance of compliance to efficacy.
The exercises must be done for around 30 minutes every day, and therefore adherence to treatment will certainly be a measure limitation, he said.
According to John E. Heffner, MD, Garnjobst Chair at Providence Portland Medical Center and Professor of Medicine at Oregon Health & Science University in Portland, compliance will be a major issue for both patients and the physicians who treat them. If proven effective in other studies, otolaryngologists and other physicians will need to refer these patients to specialists who can teach the exercises and help the patients maintain compliance, he said. Most physicians will not have the time or teaching resources to stimulate patients to enter a successful exercise regimen.
I would only consider recommending exercises for patients with bothersome snoring who do not require CPAP. I do not believe we have sufficient information yet to indicate benefit for CPAP-dependent patients to justify a prolonged exercise training period.
-John E. Heffner, MD
Acknowledging that exercise is a great option if it works, Dr. Kezirian cautioned that this may not be an option for many of the patients he commonly sees, particularly those who are obese. For these people, obstruction of the airway is caused not only by weak and collapsing muscles, but also by bulk formed by deposits around the tongue and throat. Patient selection is therefore critical when considering patients likely to benefit from exercise, he emphasized.
Dr. Heffner also suggested that this treatment approach should be recommended for only a very select group of patients. I would only consider recommending exercises for patients with bothersome snoring who do not require CPAP, he said. I do not believe we have sufficient information yet to indicate benefit for CPAP-dependent patients to justify a prolonged exercise training period.
For patients who are using CPAP and want to try this treatment approach, he recommended that they remain on CPAP until a polysomonogram confirms improvement in their sleep apnea.
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