Novel Myofunctional Nipple to Prevent Obstructive Sleep Apnea in Infants

Project Summary: There is a clear unmet need to provide a non-invasive and non-burdensome first line treatment and preventive measure for obstructive sleep apnea (OSA) in infants. Although OSA in infants typically goes undiagnosed, it is estimated that 1%-4% of infants suffer from OSA affecting as many as 5.6 million infants worldwide each year. OSA in infant populations can have detrimental impacts on long-term health, including an increased risk for obesity, developmental delays, hyperactivity, increased blood pressure, a general “failure to thrive,” and even organ damage. Less severe forms of sleep disordered breathing (SDB) such as snoring, which is prevalent in 10% of infants, can be associated with behavioral issues and diminished cognitive skills which can overall decrease the quality of life of the infant. A first line treatment in children is adenotonsillectomy (A&T), a surgical procedure that removes tonsils and adenoids. Although A&T can be effective, it is an invasive procedure that, due to risk of complications, is rarely conducted on infants below the age of one. Continuous positive air pressure (CPAP) therapy, the other prominent treatment for OSA, often causes additional issues for infants who already have respiratory issues, such as increased viral load. Myofunctional therapy consisting of oropharyngeal exercises is a promising new potential first line & non-invasive treatment of OSA for adults and children. Studies have shown myofunctional therapy to decrease apnea hypopnea index (AHI) by 14.3 events/hour in adults, 3.0 events/hour (60% reduction) in children, and reduces residual OSA in children after A&T. However, it is difficult for infants to learn and practice beneficial myofunctional exercises. There is currently no low risk, low burden device that can be used to treat OSA in infants. Many families feed their children with a bottle starting in the first six months of the child’s life, and baby bottle use during infancy can be associated with an increased risk for OSA when compared to breastfeeding: breastfeeding babies exercises oropharyngeal muscles like myofunctional therapy does. However, there are currently no baby bottles that incorporate oropharyngeal exercises into the daily drinking and feeding of infants. There is a huge opportunity to deliver oropharyngeal exercises to improve OSA in a baby bottle format. To address the lack of low risk and low burden solutions for infant OSA, we will develop an innovative myofunctional therapy baby bottle nipple and that can be easily administered to infants with OSA. The scientific premise of this project is that a novel therapeutic myo-nipple that mimics breastfeeding forces will both reduce the prevalence of infant OSA and prevent the long-term development of OSA by stimulating proper craniofacial growth and orofacial muscle development. Parents and clinicians will be interviewed to understand the requirements for successful market entry of the baby bottle myo- nipple. This will be followed by the development of a functional myo-nipple prototype that meets the requirements from clinicians and parents and incorporates defined breast-like oropharyngeal exercises. This project seeks to improve the quality of life for future generations of would-be OSA sufferers and primary snorers.