Study design considerations for sleep-disordered breathing devices.

None: In recent years, sleep-disordered breathing (SDB) has been recognized as a prevalent but under-diagnosed condition in adults and has prompted the need for new and better diagnostic and therapeutic options. To facilitate the development and availability of innovative, safe and effective SDB medical device technologies for patients in the United States, the US Food and Drug Administration collaborated with six SDB-related professional societies and a consumer advocacy organization to convene a public workshop focused on clinical investigations of SDB devices. Sleep medicine experts discussed appropriate definitions of terms used in the diagnosis and treatment of SDB, the use of home sleep testing versus polysomnography, clinical trial design issues in studying SDB devices, and current and future trends in digital health technologies for diagnosis and monitoring SDB. The panel's breadth of clinical expertise and experience across medical specialties provided useful and important insights regarding clinical trial designs for SDB devices.

The Evolution of Oral Appliance Therapy for Snoring and Sleep Apnea: Where Did We Come From, Where Are We, and Where Are We Going?

Oral appliance therapy (OAT) for the treatment of snoring and obstructive sleep apnea is accepted as the most effective noninvasive therapy second only to continuous positive airway pressure. This article explains the innovations of the previous 200 years and how they laid the groundwork for OAT today. The expansion of this treatment over the past 40 years has been explosive and evidence based. The future will be linked to changes in the medical field, continued research on appliance design, and development of personalized medicine that will appropriately identify therapy options.

Airflow Shape Is Associated With the Pharyngeal Structure Causing OSA.

BACKGROUND: OSA results from the collapse of different pharyngeal structures (soft palate, tongue, lateral walls, and epiglottis). The structure involved in collapse has been shown to impact non-CPAP OSA treatment. Different inspiratory airflow shapes are also observed among patients with OSA. We hypothesized that inspiratory flow shape reflects the underlying pharyngeal structure involved in airway collapse. METHODS: Subjects with OSA were studied with a pediatric endoscope and simultaneous nasal flow and pharyngeal pressure recordings during natural sleep. The mechanism causing collapse was classified as tongue-related, isolated palatal, lateral walls, or epiglottis. Flow shape was classified according to the degree of negative effort dependence (NED), defined as the percent reduction in inspiratory flow from peak to plateau. RESULTS: Thirty-one subjects with OSA (mean apnea-hypopnea index score ± SD, 54 ± 27 events/h) who were 50 ± 9 years of age were studied. NED was associated with the structure causing collapse (P < .001). Tongue-related obstruction (n = 13) was associated with a small amount of NED (median, 19; interquartile range [IQR], 14%-25%). Moderate NED was found among subjects with isolated palatal collapse (median, 45; IQR, 39%-52%; n = 8) and lateral wall collapse (median, 50; IQR, 44%-64%; n = 8). The epiglottis was associated with severe NED (median, 89; IQR, 78%-91%) and abrupt discontinuities in inspiratory flow (n = 9). CONCLUSIONS: Inspiratory flow shape is influenced by the pharyngeal structure causing collapse. Flow shape analysis may be used as a noninvasive tool to help determine the pharyngeal structure causing collapse.

Screening for obstructive sleep apnea in the dental office setting.

Obstructive sleep apnea (OSA) is a widespread disease with a prevalence of 4 to 9 percent in the world's population. It occurs in all age groups from neonates to senior citizens, but weight, age, race and gender all influence its expression. OSA is as common as asthma and in its severe form can cause fatal cardiovascular damage. Since a dental practice often treats entire families on a routine basis, the setting is a natural place to aid in identifying patients at risk for having OSA.