Stop Snoring Tomed SomnoGuard® Clinical Trials
SomnoGuard AP, Classic SomnoGuard, SomnoGuard 2.0
"Regarding our classic SomnoGuard launched in 2000 we have been involved in clinical research with oral appliances for many years...
Friedman M, Pulver T, Wilson MN, Golbin D, Leesman C, Lee G and Joseph NJ, Otolaryngology office-based treatment of obstructive sleep apnea-hypopnea syndrome with titratable and nontitratable thermoplastic mandibular advancement devices.Otolaryngol Head Neck Surgery, 2010, 143: 78 - 85
OBJECTIVES: 1) Share our experiences treating patients with obstructive sleep apnea-hypopnea syndrome (OSAHS) with titratable and nontitratable thermoplastic mandibular advancement devices (MADs) fitted in our otolaryngology clinic. 2) Compare these devices in terms of objective response (OR), as defined by a > or = 50 percent decrease in baseline apnea-hypopnea index (AHI) and an AHI < 20, and subjective parameters, including adherence. 3) Determine overall success, as defined by OR plus adherence at two months follow-up.
SUBJECTS AND METHODS: A prospective, non-randomized cohort study in a tertiary care center. Patients with OSAHS who tried and failed or refused both continuous positive airway pressure (CPAP) and surgical therapy were fitted with a nontitratable Snore Guard (n = 38), nontitratable (SomnoGuard, SomnoGuard 2.0) (n = 8), or titratable SomnoGuard AP (n = 41). Pre- and post-treatment assessment included: 1) Epworth Sleepiness Scale, 2) snoring level, 3) polysomnogram. Patients were contacted at two months follow-up to assess adherence and subjective parameters.
CONCLUSIONS: Thermoplastic MADs are a relatively inexpensive treatment alternative for patients with OSAHS who fail/refuse CPAP and upper airway surgery. They can be easily fitted in the otolaryngology clinic. Long-term compliance, efficacy, and safety are unknown at this time.
Since the major functions of already marketed dental devices such as the TAP, MDSA, Silencer Professional and Silencer Custom devices, i.e. lateral movement as well as advancement of the lower jaw, are also key features of our own new appliances we expect similar clinical research..., TAP appliance..., Silencer Professional..., MDSA appliance...".
For more information please see at: Anti snoring, Sleep Apnea treatments and cures Dr. Toussaint GmbH, Tomed care clinical trials SomnoGuard®
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