Crosslink augmentation to resist snoring and obstructive sleep apnea syndrome

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DESCRIPTION (provided by applicant): Snoring is a condition that affects people of all ages, with a reported prevalence of up to 48% of men and 34% of women. Snoring poses not only an inconvenience with regard to sleep-cycle disruption of the sufferer's bed partner and family, but it can also lead to sleep-deprivation in the sufferer and to a more serious and sometimes life-threatening condition, obstructive sleep apnea syndrome (OSAS), where breathing is interrupted during sleep by physical obstruction of the airway. Prevalence of OSAS in the United States has been estimated at 4.2% for those aged 16 and older, or approximately 10 million individuals. Both snoring and OSAS are in most cases the result of obstructed airflow due to abnormalities in the geometry of the air passages and the propensity for aberrant deformation of the soft palate. Repeated trauma to the soft palate due to snoring can be expected to increase its passive deformability and damage muscle fibers and peripheral nerve fibers, increasing the tendency for obstruction. Thus, treatment of snoring can play an important role in reducing the incidence of OSAS. Current treatments include surgery, the use of oral appliances, and more recently, minimally invasive procedures targeted at stiffening the soft palate. All of the newer procedures rely to some extent on the formation of fibrotic scar tissue to stiffen the soft palate. This fibrotic tissue can be expected to exhibit inferior mechanical properties and loss of structural integrity, leading to the eventual loss of some initial treatment-related benefits. This Phase I study aims to determine feasibility of injecting non-toxic protein crosslinking agents to stiffen the soft palate without producing scar tissue. Previous testing suggests that this technique can augment the soft palate's mechanical properties, reduce vibration, and concomitantly increase resistance to mechanical degradation. The overall aim of this program will be to commercialize a less expensive, faster (same-day benefit), and superior injectable treatment for the reduction of snoring, prevention of OSAS, and reduction of airway collapse. Feasibility will be evaluated in four parts: 1) the ability of crosslinking agents to improve the mechanical properties and increase the resistance to mechanical degradation of soft palate tissue will be tested; 2) a wind tunnel test system will be developed to measure the vibration magnitude and oscillation frequency of horse soft palates; 3) the wind tunnel will be used to quantify reduction of vibration in horse soft palates following preferred crosslinker injections; ad 4) safety and treatment effect will be evaluated in pilot studies involving treatment of soft palats in normal horses and horses diagnosed with dorsal displacement of the soft palate (DDSP) which involves a form of awake snoring and apnea.