Monitored Breathing Awareness Therapy for Insomnia Disorder in Older Adults

Insomnia of sufficient clinical severity to meet diagnostic criteria is present in approximatelyof older adultsnearlymillion individuals in the US aloneIf left untreatedit can lead to increased rates of depressioncognitive impairmentand cardiovascular diseaseTreatment relies on pharmacotherapysuch as sedativehypnotic therapywhich is associated with an increased risk of fallsaccidentsand deliriumcognitivebehavioral therapy for insomniaCBT Iwhich is effectivebut can take up to eight weeks or more and is limited by a paucity of trained providersand over the counter medicationsmany of which contain diphenhydraminea medication that is on the Beers Criteria for Potential Inappropriate Medications in Older AdultsThere is clearly a pressing need to develop solutions that can treat insomnia in older adultsPreliminary research conducted at the University of Pennsylvania suggests that a mobile device treatment based on core elements of CBT I and mindfulnessespecially thought redirection and disengagementcan significantly improve insomnia symptoms in up toof patients compared toin the control armInnovative aspects of this approach include the use of a physical taskthat of finger tapping timed to the breathing cycleto serve as an anchoring re orienting taskand the ability to monitorin real timepatient adherence by wirelessly transmitting to a central database a time stamped record of all tapsThe straightforward nature of this intervention allows for rapid trainingwith treatment benefits seen in as little asweeksThe overall goals of this fast track STTR are to develop and test this non pharmacologicallow risk treatment for insomnia in older adultsSpecific aims arePhase IRefining the application interface through structured interviews with patients and health care providersdevelopment of educational material for patients to access at homeintegration with accelerometer data and a pilot clinical study instudy participantsPhase IIFurther refining the educational materialcreate interpretive risk classification algorithms to automatically flag non adherence and non responders for early interventionand a large randomized controlled trial ofsubjects to confirm efficacyThe primary hypotheses are that a mobile device implementation of this monitored breathing awareness therapy with an anchoring taskMBATcan be used by rtof older adultsand that it will lead to statistically and clinically significant improvements in insomnia within two weeksAdvanced Medical Electronics hasyears of biomedical development experienceand academic partnersGooneratneBenzohave expertise in sleep medicinegeriatricsmindfulness therapy and clinical trials in older adultsIf successfulthis project will provide patientsand health care providers with the first low risklowcost treatment option for insomnia that can be readily implemented in older adultsIt has the potential to fundamentally change how insomnia is treatedthereby reducing the risks of untreated insomnia and avoiding the multifarious side effects of pharmacologic treatmentsuch as with sedative hypnotics