Scientific Partners, LLC — Department of Health and Human Services SBIR Phase I: NHLBI

Description

We propose to develop a novel minimally invasive treatment for obstructive sleep apnea OSA that uses flavored substances as a chemo attractant to engage the tongue a process that may be described as chemoactivation OSA is a disorder of symptomatic repeated upper airway obstruction during sleep that is associated with substantial cardiovascular morbidity and mortality endocrine disturbances daytime somnolence decreased quality of life performance deficits and motor vehicle crashes of OSA patients cannot tolerate first line treatment positive airway pressure and may consider other options including mandibular repositioning appliances and surgery Oral appliances and surgery may offer substantial benefit for selected patients but they carry many risks The tongue has a pivotal role in OSA pathogenesis and treatment The benefits of treatment with mandibular repositioning appliances and tongue directed surgical procedures are based on repositioning and or reduction in the size of the tongue Novel tongue directed therapies utilizing direct neuromuscular stimulation and oropharyngeal exercises have demonstrated encouraging initial results but these too can be limited by cost invasiveness compliance and or limited effectiveness Our strategy for meeting this challenge is an effective safe non invasive device for use by itself or during CPAP The RestAssure works by engaging the tongue during sleep by using flavored substances to promote tongue movement and swallowing Using a prototype first in man and pilot data are promising but require further evaluation For Phase I of this SBIR proposal we propose to optimize the efficacy of this approach in a study of subjects with newly diagnosed mild to moderate OSA based on sleep study or polysomnogram and no previous treatment In addition we will begin miniaturization and optimization of the pump that will be used on the commercial device Aim Optimize efficacy and safety with respect to flavor compounds infusion rates and dosing intervals All subjects will undergo overnight polysomnography with an intraoral mouthpiece designed to enable periodic infusion of flavored substances in the anterior oral cavity adjacent to the tongue tip The primary outcome in assessing each parameter below will be the reduction in OSA severity apnea hypopnea index from the sleep study polysomnogram Exploratory outcomes include usability user acceptance and changes in arousal index Adverse events will be measured a Assess sweet xylitol versus salty saline versus control water flavors b Assess infusion rates c Assess duration and interval Aim Develop a prototype infusion device The optimization in Aim will utilize an existing portable benchtop infusion pump For our commercial product however we will develop a body worn infusion device obviating the need for external tethers or equipment We propose to develop a novel minimally invasive treatment for obstructive sleep apnea OSA using flavored substances OSA is a disorder of symptomatic repeated upper airway obstruction during sleep that is associated with substantial health problems including cardiovascular disease and decreased quality of life Tongue directed therapies have demonstrated encouraging results but these suffer from substantial cost invasiveness compliance and or limited effectiveness Our strategy is an effective safe device that uses flavors to engage the tongue during sleep