The Importance of Clinical Trials for "Snore Stoppers"

Snoring is one of the most common sleep problems faced by people all around the world. According to the National Sleep Foundation, it affects approximately 90 million American adults, with over one third of those adults suffering from snoring on a regular basis. Another study produced by the BBC revealed that 40% of women and 50% of all men snore. With statistics like these, it is little wonder that many products have been created – or are in the process of being created – to try to resolve this issue. After all, snoring not only causes sleep disruptions and strife in relationships, but it can also increase one’s chances of suffering from life-threatening health conditions, such as a heart attack. In the past, users have experienced problems with anti-snore products; they have found them embarrassing to wear when laying with a loved one, or they have found the device uncomfortable (such as the CPAP mask). This has led to a whole new market of so-called “snore stoppers” to hit the scene and, while many seem promising, there is no clinical proof to support their claims.

An Idea Is Just An Idea

Several innovative and cutting-edge ideas for snore stoppers that are said to be comfortable and effective for users have recently been announced to the public. Many of these product ideas have found their way onto crowdfunding sites and have raised hundreds of thousands of dollars. Some have even received international media attention. While their marketing is impressive, at the end of the day an idea is just an idea. Such products have to be proven to work, and to work in a variety of conditions and with different types of snorers. For example, some individuals may snore simply because of a medication they are taking, while others may be snoring because they have sleep apnea. Snoring solutions need to address the cause of the snoring, and be proven to work for that particular issue. However many snore stoppers are offered as a solution for all types of snoring – which could be dangerous for users who are actually suffering from sleep apnea, and are not just chronic snorers.

Where’s The Proof?

Whether a product is truly effective is revealed in the clinical trials in which the manufacturer or creator of the product has invested. When a product has been the subject of a clinical trial, the results will indicate whether the product works, and under what conditions and circumstances. It is only when such research has been conducted can a user decide, with confidence, if the product will work for them.

How Does A Clinical Trial Work?

How a clinical trial is conducted will differ by jurisdiction, but all trials are carefully designed to address specific research questions. When it comes to snoring, clinical trial teams will usually include doctors, nurses, and other professionals who are knowledgeable about snoring and its treatment. They will check the health of all participants at the beginning of the trial and then assess whether they can participate. If they are found eligible and agree to participate, they are then carefully monitored and assessed during the trial and once it is complete.

How Medical Devices Are Tested By The FDA

Numerous anti-snoring devices, from basic tongue depressors to complex equipment such as a robotic surgical device, undergo clinical trials.  The majority of anti-snoring devices do not to pass this stage and are not cleared by the FDA, which could be why many snore stoppers on the market today are not backed by clinically proven results. But as the FDA states, clinical studies are imperative to protecting your health. Without a clinical trial, the anti-snore device of your choosing may at best, be ineffective, and at worst, be a risk to your health.

The Focus During A Medical Device Clinical Study

Most medical device clinical studies will involve anywhere from 10 to 40 patients, and the closer the trial is to having 40 patients involved, the better. The clinical study questions will be focused primarily on two very important aspects:

1. The safety of the product; and
2.  The potential benefit/value of the product

An example of an anti-snoring medical device clinical study is that conducted by the inventors of the Good Morning Snore Solution.

Results Of The Good Morning Snore Solution by MPowrx Clinical Study

The Good Morning Snore Solution has become a snore solution leader because it is effective – and that effectiveness has been proven through a clinical study which was published in the Journal of Sleep and Breathing in May 2008. The clinical study involved 32 pre-approved patients who were subjected to a randomized and controlled cross-over study which involved the Good Morning Snore Solution and a control device with a similar design, but which lacked the suction mechanism. For one week each of the subjects used one device and used the other device the next week. They were evaluated on the following:

• The Respiratory Disturbance Index
• The Snoring Index
• Epworth Sleepiness Scale

The clinical trial delivered some exciting results:

• On average, the Respiratory Disturbance Index was reduced by at least 50% in over one-third of subjects (therapeutic success is defined as a reduction in Respiratory Disturbance Index to 30).
• On average, the Snoring Index was reduced by nearly 40%
• The majority of patients involved (more than 70%) wanted to continue using the device because it improved their daytime sleepiness and/or their snoring

Snoring is an issue which can affect one’s overall lifestyle, their relationships, and even their career. But it is important to not grasp at every product that is launched to the market, despite the hype that surrounds them. Not all of them are effective and most do not support their claims with solid clinical data. When choosing a snore solution, consider your sleep concerns, your health, and which solution you will realistically be able to use regularly. With your physician by your side, you will be able to find the right snore solution for your health and lifestyle.

References: https://sleepfoundation.org/sleep-disorders-problems/other-sleep-disorders/snoring http://news.bbc.co.uk/2/hi/health/1552168.stm https://en.wikipedia.org/wiki/Snoring#cite_note-23 http://www.fda.gov/downloads/Training/ClinicalInvestigatorTrainingCourse/UCM378265.pdf https://goodmorningsnoresolution.com/clinically-proven-snore-solution