![]() ![]() ![]() This study evaluates the safety and effectiveness of this device as it would be used as an over-the-counter treatment option. It is customized to each patient with a ‘boil-and-bite’ fitting method, and is simple to use. Instead of advancing the mandible, the novel device restrains the tongue during sleep, increasing airflow through the airway. This study evaluates a relatively inexpensive oral mouthpiece that does not require a prescription to reduce snoring. With the barriers to treatment, many habitual snorers do not seek treatment or find relief. Patients have been shown to be almost three times as likely to choose an intraoral device to manage their snoring, rather than a CPAP machine. In one study, fewer than 20% of patients accepted a CPAP machine to treat their snoring. Ĭontinuous positive airway pressure (CPAP) machines are highly effective at treating snoring, but compliance is extremely low due to discomfort of wearing the device and the noise that it generates. ![]() In fact, between 50 and 82% of patients with mandibular repositioning devices reported at least one side effect with use. These can be effective in reducing snoring for some patients, but are expensive, require a prescription, and can have side effects like excessive salivation, TMJ pain, dental pain, and bite change. However, low compliance means these techniques often are not enough to manage snoring.Ī dentist or physician can also prescribe an intra-oral device, often one that functions by repositioning the mandible forward to increase airway space. Often the initial steps in treatment are self-care techniques, including losing weight, reducing alcohol intake, or changes in sleeping position. Snoring often goes untreated unless it is accompanied by evidence of a more serious sleep disorder or a patient specifically requests treatment. Partners of snorers have reported more morning headaches, fatigue, and daytime sleepiness. Of those bothered by their partners snoring, 40% responded by sleeping in separate bedrooms at least once a week, while about one-quarter tried sleep aids like ear plugs, sleeping pills, or other interventions. One study reported that more than half of partners were often disturbed by the snoring and 35% reported it caused relationship problems. The impact of snoring is often born by the partner of the habitual snorer. Risk factors for snoring include obesity, use of alcohol/tranquilizers, smoking, nasal obstruction, and the male sex. The prevalence of snoring has been estimated at 25-40% of the overall population. Snoring is associated with other sleep disorders like sleep apnea and hypopnea, but does not necessarily indicate the presence of a more serious sleep disorder. Snoring occurs when vibrations of the pharyngeal airway create a respiratory sound during sleep. This study demonstrates a novel, affordable, over-the-counter device was able to significantly improve the symptoms of snoring for both individuals and their partners. No significant differences were noted in the effectiveness of the device based on body-mass index, age, or gender. The device does not reposition the mandible, reducing the risk of temporomandibular joint (TMJ) or facial pain. Use of an intraoral device that restrains the tongue demonstrated significant benefit in the reduction of snoring symptoms among habitual snorers. No adverse events were noted, and fewer than 1% reported issues with the fit of the device. In total, 91% of users reported benefits from the device. A significant improvement was noted in the Snoring Severity Scale (67%), how much snoring bothered the individual (52%), and how much snoring bothered the partner (60%), and the frequency of snoring (57%). After signing the informed consent, they completed an initial questionnaire about their symptoms and another following 10 days of using the device.Ī total of 570 individuals completed the study. Individuals who self-reported snoring enrolled in the study and were sent an investigational device. The purpose of this study was to evaluate the effectiveness of a novel intraoral device that restrains the tongue in an over-the-counter setting in a population of habitual snorers. Habitual snoring affects millions of individuals and their partners, but often goes unresolved due to the high cost of care and other barriers to treatment. ![]()
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