The proposal requests funding for the development and proof-of-concept testing of the second generation of a novel, minimally invasive sleep apnea device, the LinguaFlex Tissue Retractor (LTR-II). Obstructive sleep apnea (OSA) is a common disorder with high morbidity and mortality. It is estimated that up to 20% of the United States population is affected while most patients remain undiagnosed. A new technology, the LinguaFlex Tongue Retractor (LTR-I), was developed and recently tested in pre-clinical and clinical trial. The human trial proved safety of the first-generation device and the therapy was effective in reducing airway obstructions in approximately two-thirds of the subjects tested. The first-generation LTR is inserted in the tongue midline by a needle injection and works by preventing backward collapse of the tongue base during sleep. It was designed to treat the more severe cases of OSA. LTR-II is being developed to treat mild to moderate form of the disease. It retracts all three areas of the upper airway whose collapse directly contributes to airway obstructions in OSA, namely the tongue base, the soft palate and the lateral pharyngeal walls. Preliminary work shows that this lateral approach with the second-generation device is highly promising. This study will provide proof-of-concept of the safety and efficacy of LTR-II in an animal model. Moreover, tissue interaction and tension characteristics of LTR-II and the upper airway will be studied in the human cadaver model to characterize the device specifics for optimum function. Both models were successfully used in the development of LTR-I. The lateral technique also offers the advantage in being less invasive and painful and more comfortable for the patients while being easier to perform compared to the first-generation device. An SBIR proposal for Phase I clinical trial is planned for submission at the completion of these studies. If successful, the devices will provide an acceptable alternative to CPAP and a significant advance in OSA treatment across all severity range of the disease.
Sleep apnea is a disorder that affects millions of Americans in which a person stops breathing during sleep for 10 seconds or longer. These episodes are known as apneas. People who have a severe form of sleep apnea can have hundreds of such episodes per hour during the night. Untreated sleep apnea results in increased risks for high blood pressure, stroke, diabetes, and even death. Current therapies for sleep apnea include major surgery or lifelong use of a nightly respirator. This project allows for the development of a new therapy intended to treat sleep apnea in a comfortable and acceptable manner. The therapy involves the insertion of a thin, elastic implant into the side of the tongue, under local anesthesia. The device will be tested in animals and human cadaver specimen. These studies will lead to further development of the device for clinical trial. The specific goals of this project are to develop and test this new medical device to prevent sleep apnea and later perform a small safety clinical trial in a follow up study.