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is a clinical study on a ResMed product done at the ResMed Sleep Research Center reliable?

SAN DIEGO, Sept. 16 /PRNewswire-FirstCall/ -- ResMed (NYSE:RMD - News), a leading developer, manufacturer, and distributor of sleep and respiratory medical equipment today announced the results of a clinical study confirming that patients' compliance with sleep therapy increases when using ResMed's new CPAP device.

The clinical study of 50 patients suffering from sleep apnoea showed an improvement of 30 minutes in average daily usage, from a mean of 6 hours 35 minutes on the patient's usual CPAP device, to 7 hours 5 minutes, when using the new S9 Series.

Sleep apnoea is one of the more common, and yet highly undiagnosed, sleep disorders. Obstructive sleep apnoea (OSA) is the most common type of sleep apnoea and is marked by the collapse or obstruction of the airway during sleep. The most effective treatment is Continuous Positive Airway Pressure (CPAP) therapy. In this non-invasive treatment, air is pressurised by a small device and delivered to the airway of the patient through a mask that fits on/over the nose, or nose and mouth. The pressurised air keeps the upper airway open and helps the person to get a restful night without interruptions caused by apnoeas.

A patient's ability to comply with sleep therapy, however, is affected by potential negative side effects, such as noise from the device, nasal dryness/congestion and breathing discomfort. To combat these side effects and increase patients' ability to adhere to the sleep therapy, ResMed has developed new improved features for its S9 Series including reduced noise, improved humidification system, and a more comfortable breathing system.

After testing ResMed's new sleep apnoea therapy platform, patients rate the S9 Series as significantly better than their current device in comfort of breathing, dryness of nose and mouth, rainout, and noise. In terms of overall preference, 78% preferred the S9 Series, over their current device.

"For the first time with our new ClimateControl™ system, air is delivered quietly and comfortably at the precise temperature and humidity that the sleeping patient, provider, and physician have set.  S9 Series provides a significant, patient-perceptible difference in comfort; a true leap-forward for sleep apnoea therapy," said Michael Farrell, SVP of the Global Sleep Business Unit at ResMed.

Studies conducted by researchers at Harvard Medical School show that a lack of sleep negatively affects perception and judgment. In the workplace sleep deprivation can result in reduced efficiency and productivity, errors, and accidents. Studies from the Clinical Sciences Research Institute at the University of Warwick suggest that between 6-8 hours of sleep is the optimal range.

"We are extremely pleased to see patient tests confirm that the S9 Series increases patient's compliance and quality of life, making the device a true revolution in positive airway pressure therapy," added Frank Klein, VP, European Sleep Business Unit at ResMed.

About the study

The ResMed S9 Compliance Study was conducted as a clinical study of 50 patients at the ResMed Sleep Research Centre in Sydney, Australia. The three month study comprised three stages: a retrospective study where the patients used their own device for 28 days, followed by 28 days testing S9 in a prospective study, and finally returning to the patient's own device for 28 more days in a prospective study.  

The purpose of the study was to assess whether compliance is improved by ResMed's new S9 Series, which features reduced noise, an improved humidification system and a more comfortable breathing experience. In terms of average daily usage, compliance on the S9 Series was significantly better than compliance on the patient's own device, both before and after trialling an S9 device.

The study is registered in the clinical trial registry ClinicalTrials.gov, Identifier: NCT01013207

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I am always skeptical of clinical trials that are sponsored by the company that manufactures the device, etc.

Data can be manipulated and does anyone really think if the results show different results -- say a decrease in compliance or other that they will publish the report?
I'd say 50 people does not make a fair trial, especially when conducted by the marketing company
Pointless; this isn't a study. This is marketing.

Don't believe any "study" unless the organisation carrying it out has signed up to the appropriate ethical standards; ie undertaking to publish all the studies they commission - favourable and unfavourable - and all the results - pro and con.

If they haven't ignore them.

Usually, companies cherry pick the results from "good" studies and quietly ignore or discard studies that turn up unfavourable results. Later meta studies are then biased because the "bad" ones have been hidden.

There's nothing wrong with marketing but it should be honest. Not like women's beauty products where "7 women tested said..."
Yup, yup, to the marketing. Manufacturers pay their publicity people BIG bucks to put the "correct spin" on "studies" or bury the unflattering, undesireable, study results DEEP in the hopes they are never seen or found.

I'm pretty sure it was 1987 that our US government greatly reduced the restrictions on pharmaceutical and medical advertising and today these same companies spend MORE on advertising than they do on research and development. Now we get to watch hemorrhoid and flavored KY jelly commercials during our dinner hour. And the twin Cialis bath tubs during the local news reports. (What IS the significance of those twin bathtubs to the use of Cialis??? Anyone know? Its sure over my head!!!).

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