BARRON ASSOCIATES, INC. — Department of Health and Human Services SBIR Phase I: NHLBI

Description

DESCRIPTION provided by applicant Obstructive sleep apnea OSA is characterized by the repetitive closure of the pharyngeal airway during sleep that is associated with oxygen desaturation and or arousal Patients with OSA are at increased risk of coronary artery disease chronic heart failure hypertension stroke type diabetes and motor vehicle industrial accidents With regard to middle aged adults approximately of men and of women have mild to moderate OSA and another of men and of women have moderate to severe OSA as de ned by the apnea hypopnea index AHI mean number of apneas and hypopneas per hour of sleep |mild AHI andlt moderate AHI andlt and severe AHI OSA is a serious and growing healthcare problem in the U S The American Academy of Sleep Medicine AASM current practice parameters recommend oral appliance OA therapy such as use of a mandibular advancement appliance MAA as a first line treatment in patients with mild to moderate OSA as well as in patients with more severe OSA who do not have success with positive airway pressure PAP therapy MAAs pull the mandible forward an adjustable amount reducing the obstruction of the upper airway during sleep Substantially better results are obtained using MAAs that are custom made by dentists Approximately half of patients who attempt PAP therapy cannot tolerate the treatment and prefer an MAA as a less invasive and more portable therapeutic option Compared to PAP machines MAAs are also easier to travel with and do not require electrical power they are a particularly important treatment alternative for individuals with OSA who are employed by the transportation industry e g commercial truck drivers airline pilots etc whose work often requires them to be away from home The capability to monitor patient adherence is crucial and is incorporated into essentially all modern PAP units A major factor limiting wider application of MAA treatment is the present inability to objectively quantify patient adherence to treatment The need to introduce objective adherence monitoring into OAs is of great importance for both clinical practice and research The proposed Dental Sentinel will overcome present barriers and offer the capability for adherence monitoring in MAAs and other OAs e g orthodontic retainers This will put MAAs on the same footing with PAP in this regard as almost all PAP units electronically record the time that the breathing circuit is pressurized which is a precise measure of actual usage time The Dental Sentinel is a miniature adherence and sleep monitoring micro recorder that is implanted into the OA It employs temperature orientation and motion sensors in a novel way to determine daily use of the OA i e adherence as well as providing objective measurement of MAA related improvements in AHI i e treatment ecacy augmenting subjective patient self reports to clinicians Monitoring algorithms prevent users from purposely deceiving the device an important capability to satisfy present and future transportation industry regulatory requirements The Dental Sentinel will use its recharging console to upload data to a secure cloud based server where it can be accessed by authorized individuals PUBLIC HEALTH RELEVANCE The proposed Dental Sentinel will facilitate the routine clinical management of patients receiving oral appliance OA therapy as well as the conduct of population based effectiveness research and clinical trials that monitor the adherence and effectiveness of treatment for sleep disordered breathing including obstructive sleep apnea OSA chronic snoring upper airway resistance syndrome and obesity hypoventilation syndrome It is also critical to fulfilling current and future transportation industry regulatory requirements such as those that pertain to commercial truck drivers motor coach drivers airline pilots railroad engineers and mariners which elevates the Dental Sentinel andapos s commercial potential documentation of treatment for sleep apnea is already an ongoing requirement for pilot and commercial motor vehicle driver certification Access to treatment adherence data will be an essential component in the management of patients with OSA using mandibular advancement appliances MAAs just as it is today for positive airway pressure PAP therapy