Newswise — Experts estimate that nearly 60 million adults snore, an annoyance that can lead to marital discord, social problems, and even homicide. Snoring can also be an indicator of obstructive sleep apnea, a potentially life threatening condition marked by breathing cessations during sleep.
Habitual snoring, which is estimated to affect from 24 to 50 percent of men and 14 to 30 percent of women, is a symptom of sleep-disordered breathing and stems from vibration of anatomical structures of the upper aerodigestive tract while sleeping. Traditional treatments for snoring can range from weight loss to a change in sleeping patterns to one of multiple well-documented surgical options. Many patients decline to seek a surgical solution or change their lifestyle to solve their snoring problem.
Although there are multiple well-documented surgical options for snoring, many patients prefer to try non-invasive aids first due to convenience, decreased convalescence or fear of surgery and the associated discomfort.
Currently, over 300 non-invasive, over-the-counter snoring remedies are registered with the U.S. Patent and Trademark Office. However, the question remains, "Do these treatments really work?" Peter G. Michaelson, MD, and Eric A. Mair, MD, both at Wilford Hall USAF Medical Center in San Antonio, Texas, address this question. Their study "Popular Snore Aids: Do they work?" will be presented at the American Academy of Otolaryngology—Head and Neck Surgery Foundation www.entnet.org Annual Meeting & OTO EXPO, Orlando, FL, being held September 21-24, 2003.
Methodology: Forty patients (29 men and 11 women), who complained of socially disruptive snoring were enrolled in the study at Wilford Hall USAF Medical Center. Patients less than 18 years of age and those with medical conditions that could interfere with the proper operation of the investigation's materials or analysis sleep device were excluded. Those with suspected obstructive sleep apnea were not excluded from the study.
Three non-invasive, over-the-counter snore remedies were chosen based on multiple independent Internet searches, patient interviews, product uniqueness, and lack of unbiased scientific analysis. Products selected included the lubricating mouth spray (Snorenz(r)), nasal dilator strips (Breathe Right(r) Strips) and an ergonomically shaped pillow (Snore-No-More(r)). Proper use and instructions as per the products' website or package insert were reviewed prior to meeting with the patients and all patients were given the same directions on use. None of the products claim to treat obstructive sleep apnea.
Each study participant provided a complete medical history, completed the Epworth sleepiness questionnaire, and underwent a physical exam during which characteristics such as neck size, height, and body mass index were recorded.
Participants engaged in seven consecutive nights of SNAP testing (a take-home polysomnograph device that generates an analysis of acoustic measurements of oronasal respirations as well as a respiratory disturbance index (RDI)). The first, third, fifth, and seventh nights were to be tested without the use of any snore remedy; the remaining nights were reserved for product testing. Compared were chosen study parameters, both objective and subjective, for the night a product was tested and the following night without a snore aid (control night). Patients were asked to refrain from the use of alcohol or other sedatives during the course of the study. Objective snoring analysis was performed using the SNAP test (evaluated in a blinded fashion by SNAP Laboratories, Inc, Glenview, IL). In order to subjectively measure patient and sleeping partner satisfaction with the products, daily questionnaires were completed each morning following testing with and without remedies.
Results: Ages of the 40 study participants ranged from 19 to 67 years old with a mean age of 44. Body mass index ranged from 20 kg/m2 to 40 kg/m2, with an average of 28 kg/m2. Neck sizes were from 11.5 inches to 18.5 inches for an average of 15.4 inches. Epworth Sleepiness Scale scores ranged from zero to 22 with a mean of 10.85. Of the 40 tested patients, 3 missed one or more nights of SNAP testing making the true sample size 37.
Wilcoxon signed rank tests were applied to compare differences between the tested snoring parameters of the night of product use and the following night without use. Windows-based SPSS Version 11.5 was used for the statistical analysis. The measures examined were the proportion of total snoring originating from the soft palate (%), the weighted average loudness of the snoring noise from the soft palate (dB), the averaged loudness of the total snoring noise over the recording period (dB), and the averaged palatal flutter frequency (Hz). These four parameters had been shown in previous studies to improve with surgical snoring procedures and are objectively statistically significant snoring parameters. Also studied was the RDI and daily subjective questionnaires completed by the patients and their bed partner. The questionnaire had multiple questions for each, relating to happiness with the previous night's sleep, snore remedy and the desire to recommend the aid to others.
Between the four objective snoring variables, RDI and the subjective questions to patient and partner, no statistically significant difference was found between the product testing nights and control nights. A post-hoc power analysis was performed revealing 80%, and thus, adequate power to conclude no snoring improvement, objective or subjective, with use of the studied snore aids.
With so many of these proposed remedies being commercially available without a prescription or even a medical evaluation, the consumer must be well informed. Many of these products which contain multiple herbs, vitamins and minerals may not be FDA regulated and may be free from the scrutiny of product evaluation and safety. Possible side effects and various interactions are possible and must be researched. Use of these products may also delay proper evaluation and treatment of snoring's associated disease, obstructive sleep apnea. More controlled studies are needed on non-FDA regulated items to evaluate performance, possible interactions and most of all, safety.
Conclusions: This is the first prospective comparison trial of popular non-invasive snoring aids. Objective and subjective analysis show no difference in snoring whether patients use selected over-the-counter snoring aids or nothing. The over-the-counter products tested do not reduce snoring, RDI, or subjective perceptions of snoring.
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