AHI is Not the Whole Story


A study published in Nature and Science of Sleep contends that “continued indiscriminate use of the apnea-hypopnea index (AHI) should be discouraged.” Instead, researchers suggest that numerous alternative measures be incorporated to provide the total sleep picture.


Determining exactly what is being counted during the AHI is thoroughly examined, with researchers concluding that “it is inconceivable that all apneas and all hypopneas are the same kind of exposure, as far as effects are concerned. For instance, the clinical consequences of not breathing for 60 seconds cannot be identical to the consequences of shallow breathing for 30 seconds, and the consequences of accompanying hypoxemia surely depend on its magnitude and duration, not on an arbitrary cutoff point.”


Many of the arguments and/or alternative measures presented presented in the full study extend to other ratio variables that are commonly used in sleep research, such as the arousal index, percentage of time in desaturation, and percentage of time in each sleep stage. “In fact, the modeling of ratios has been harshly criticized in other branches of science as well,” write researchers.


“However, the lessons offered are far more general. First, a variable that is useful in clinical practice is not necessarily the preferred variable in biomedical science. Second, we should never accept a new variable into science on the basis of feelings or authority. Third, if the analyzed variable is a derived variable, researchers should explicitly state which natural variable they claim to be measuring. And if they are unwilling to commit to a clear theory, they are not in the business of science.”


Click Here to read the full study.



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A Pill for Sleep Apnea? A Pennsylvania-Based Pharma Company is Working on It


The Philadelphia Business Journal is reporting that Philadelphia-based Galleon Pharmaceuticals is working on a pill to treat sleep apnea.


The report reveals that James C. Mannion, founder and CEO of the 9-year-old Horsham biopharmaceutical company, is in the process of raising $20 million to support clinical testing of its two lead products: GAL-160, an oral medicine for sleep apnea and GAL-021, an intravenous drug being developed to treat respiratory complications in hospitalized patients receiving anesthetics and opioids for pain relief.


“The company has raised about $50 million from investors including venture-capital firms TPG Biotech, Morgenthaler Ventures and Healthcare Ventures,” George writes. “In 2005 Galleon received $500,000 in seed funding from BioAdvance, operator of the Biotechnology Greenhouse of Southeastern Pennsylvania. While potential applications for Galleon’s technology and compounds cover a range of breathing control disorders, Mannion said he will typically provide a more brief description of the company when meeting with potential investors.”


“I tell them we are developing a pill for sleep apnea,” said Mannion in The Journal. “Many people can relate to sleep apnea. Usually when I am in a room talking to people about the company, there is somebody who has it or whose brother, cousin, uncle or spouse has sleep apnea. They all say the same thing: People with sleep apnea hate wearing the mask.”


Mannion told George that to the best of his knowledge, no big pharma companies are working on a pill to treat sleep apnea. He noted the company combines elements of respiratory medicine and neurology in their research. “Most of the big pharmaceutical companies work in one area, but not both,” he said. “If they do both, (the researchers) usually work separately. We don’t have those silos.”


Source: Philadelphia Business Journal

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Blood Pressure and Glycemic Control Better with CPAP


Researchers form the United Kingdom piled more evidence on to the growing mountain that confirms the benefits of CPAP. In the latest research titled  ”Clinical Outcomes and Cost-effectiveness of Continuous Positive Airway Pressure to Manage Obstructive Sleep Apnea in Patients With Type 2 Diabetes in the U.K.”, treatment with CPAP led to significantly better diabetes and blood pressure control at 5 years among diabetics with obstructive sleep apnea, according to results from a case-control study in 300 patients.


The researchers, led by Julian F. Guest, PhD, of Catalyst Health Economics Consultants in Middlesex, England, and King’s College London, examined records from 150 patients with type 2 diabetes and obstructive sleep apnea (OSA). According to reporter Jennie Smith, the data was culled from a national health database that identified who had been treated with CPAP for up to 5 consecutive years, of whom 139 remained on CPAP at year 5, and compared these with 150 controls with both OSA and type 2 diabetes who were not on CPAP.


Click Here for Abstract 


CPAP-treated patients had better diabetes management and blood control than their peers who did not use the breathing machines. “Guest and his colleagues sought to discern not only clinical differences between the study groups but also differences in cost effectiveness, and found advantages with CPAP for both,”. “CPAP-treated patients had better-controlled diabetes than did the control patients at 5 years, with hemoglobin A1c of 8.2% in the CPAP group, compared with 12.1% among controls, a significant difference.”


CPAP was also seen increasing patients’ health status significantly, by 0.27 quality-adjusted life years/ patient over the 5-year period, while diminishing costs incurred. In both CPAP users and control patients, blood pressure declined over the study period, and patients’ blood pressure in the CPAP-treated group was significantly lower than that of control patients by year 5.


Source: American Diabetes Association

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3D Printer Fabricates Oral Appliance


Add oral appliances to the list of new uses for the so-called “3-D printer.” The new manufacturing process applied to the familiar item comes courtesy of Australian dental company Oventus and researchers at the Commonwealth Scientific and Industrial Research Organization (CSIRO).


According to reports, the two entities collaborated to come up with a customized mouthpiece to treat sleep apnea. “When Oventus came to CSIRO with this idea, we were really excited. The possibilities of 3D printing are endless and the fact that we can now design and print a completely customized mouthpiece for patients is revolutionary,” said John Barnes, CSIRO’s 3D printing expert.


Reporter Samantha Olson writes that the invention of 3D printing has opened doors for many new inventions and process simplifications, and works by laying down thin layers of a material until it builds into a three-dimensional solid object. The machine bases the process off of a specific digital design, which Oventus CEO Neil Anderson believes was the key to their new 3D treatment.


“The finished product is printed from titanium and coated with a medial grade plastic, which looks much like a retainer,” writes Olson. “It extends from the user’s mouth like a whistle and divides up separate airways in order to channel airflow into the back of the throat. The air will be directed around the obstructive nose and partial throat collapse, to where it can travel down the trachea and avoid the nightly sleep apnea choking.”


“This new device is tailored to an individual’s mouth using a 3D scan and is used only on the top teeth which make it more compact and far more comfortable,” said Anderson in the article.


Soucre: CSIRO

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Time Magazine Declares Sleep the “New Health Frontier”



Sleep specialists and sleep lab directors can now say, “I told you so,” thanks to an April 2014 Time Magazine feature that boldly declares sleep as nothing less than the “New Health Frontier.” The 1,300-plus word article in the venerable news magazine quotes prominent sleep physicians who readily declare sleep as one of the three pillars of good health, right next to diet and exercise.


Time reporter Alexandra Sifferlin writes that, “Researchers have known for some time that sleep is critical for weight maintenance and hormone balance. And too little sleep is linked to everything from diabetes to heart disease to depression. Recently, the research on sleep has been overwhelming, with mounting evidence that it plays a role in nearly every aspect of health.”


“It’s common knowledge that sleep is needed for day to day function,” says Dr. David Rapoport, director of the Sleep Medicine Program at NYU School of Medicine in the Time article. “What isn’t common knowledge is that it really matters—it’s not just cosmetic.”


Sifferlin points out that while diet and exercise have been a part of public health messaging for decades, doctors and health advocates are now beginning to argue that getting quality sleep may be just as important for overall health. “Sleep is probably easier to change than diet or exercise,” says Dr. Michael Grandner, a sleep researcher at the University of Pennsylvania in the article. “It may also give you more of an immediate reward if it helps you get through your day.”


Click Here to see the full Time Magazine article

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New Study Validates Bright Light Therapy



One of the lead researchers on a Harvard Medical School study told delegates at the American Academy of Neurology (AAN) 66th Annual Meeting that “Light therapy may be a novel nonpharmacological intervention for Parkinson disease.”


Aleksandar Videnovic, MD, Clinical Neurological Research Institute, Massachusetts General Hospital, Harvard Medical School, declared that bright-light therapy is safe and effective in improving excessive daytime sleepiness (EDS) in patients with Parkinson’s disease, according to a small new study presented this week titled “Bright Light Therapy Improves Excessive Daytime Sleepiness Associated with Parkinson’s Disease”.


Sleep disturbances, he said, are among the most common and disabling nonmotor manifestations of PD, affecting as many as 90% of patients. “Exposure to bright-light therapy was associated with significant improvement in excessive daytime sleepiness, and this effect persisted to the end of the intervention and 2 weeks after,” said Dr. Videnovic. “No similar effect was observed in the group treated with dim red-light therapy.”


Medscape reporter Pauline Anderson writes that a chronic experimental model of PD reveals that exposure to light facilitated recovery of motor function. “The current study included 30 patients with PD (13 men and 17 women; mean age, 63 years) who were experiencing EDS, defined as an Epworth Sleepiness Scale (ESS) score of 10 or more,” writes Anderson. “Researchers randomly assigned these patients to a bright-light (5000 lux) group or to a dim red-light (less than 300 lux) control group. Participants received the light therapy in 1-hour sessions twice a day for 2 weeks (lux is the measure of light intensity at a specific distance from a light source).”


Session chair, Bradley V. Vaughn, MD, professor, neurology, University of North Carolina School of Medicine, Chapel Hill, commented in Medscape that it’s still early days for interventions such as bright-light therapy in PD. “We are still early in the process of trying to figure this out,” he said. “However, from the results Dr. Videnovic presented here, clearly this is something that is encouraging and exciting.”


Source: American Academy of Neurology (AAN) 66th Annual Meeting

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CPAP Improves Diabetes Control in Patients with Sleep Apnea



Use of CPAP led to long-term improvements in blood pressure and blood glucose in patients with obstructive sleep apnea and type 2 diabetes, according to a five-year study in UK general practice. The article titled “Clinical Outcomes and Cost-effectiveness of Continuous Positive Airway Pressure to Manage Obstructive Sleep Apnea in Patients With Type 2 Diabetes in the U.K.” published in Diabetes Care, summarized that CPAP treatment also improved patients quality of life at an acceptable cost to the National Health Service.


The study looked at the outcomes of 150 patients with type 2 diabetes who received treatment for obstructive sleep apnea with CPAP over five years, compared with those of 150 matched control patients who did not receive the treatment. The CPAP-treated patients had lower systolic and diastolic blood pressure at five years, and successively lowered HbA1c levels over five consecutive years, compared with the untreated patients. CPAP was also associated with improved quality of life over the five years, with a gain of 0.27 quality-adjusted life years (QALYs) per patient.


At a cost to the National Health Service of £4,141 for each patient over five years, the researchers calculated the cost per QALY gained with CPAP was £15,337. The study’s authors, led by Dr Julian Guest at King’s College London, concluded: “Initiating treatment with CPAP in obstructive sleep apnea patients with type 2 diabetes leads to significantly lower blood pressure and better controlled diabetes and affords a cost-effective use of NHS resources.”


Click Here for Abstract

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