Insomnia of sufficient clinical severity to meet diagnostic criteria is present in approximately 5% of older adults, nearly 1.3 million individuals in the US alone. If left untreated, it can lead to increased rates of depression, cognitive impairment, and cardiovascular disease. Treatment relies on pharmacotherapy, such as sedativehypnotic therapy, which is associated with an increased risk of falls, accidents, and delirium; cognitivebehavioral therapy for insomnia (CBT-I), which is effective, but can take up to eight weeks or more and is limited by a paucity of trained providers; and over-the-counter medications, many of which contain diphenhydramine, a medication that is on the Beers Criteria for Potential Inappropriate Medications in Older Adults. There is clearly a pressing need to develop solutions that can treat insomnia in older adults. Preliminary research conducted at the University of Pennsylvania suggests that a mobile device treatment based on core elements of CBT-I and mindfulness (especially thought redirection and disengagement) can significantly improve insomnia symptoms in up to 55% of patients compared to 30% in the control arm. Innovative aspects of this approach include the use of a physical task, that of finger tapping timed to the breathing cycle, to serve as an anchoring/re-orienting task, and the ability to monitor, in real-time, patient adherence by wirelessly transmitting to a central database a time-stamped record of all taps. The straightforward nature of this intervention allows for rapid training, with treatment benefits seen in as little as 1- 2 weeks. The overall goals of this fast-track STTR are to develop and test this non-pharmacological, low-risk treatment for insomnia in older adults.
Specific aims are: Phase I) Refining the application interface through structured interviews with patients and health care providers, development of educational material for patients to access at home, integration with accelerometer data and a pilot clinical study in 20 study participants; Phase II) Further refining the educational material, create interpretive risk classification algorithms to automatically flag non-adherence and non-responders for early intervention, and a large randomized controlled trial of 240 subjects to confirm efficacy. The primary hypotheses are that a mobile device implementation of this monitored breathing awareness therapy with an anchoring task (MBAT) can be used by >85% of older adults, and that it will lead to statistically and clinically significant improvements in insomnia within two weeks. Advanced Medical Electronics has 23 years of biomedical development experience, and academic partners (Gooneratne, Benzo) have expertise in sleep medicine, geriatrics, mindfulness therapy and clinical trials in older adults. If successful, this project will provide patients, and health care providers with the first low risk, lowcost treatment option for insomnia that can be readily implemented in older adults. It has the potential to fundamentally change how insomnia is treated, thereby reducing the risks of untreated insomnia and avoiding the multifarious side effects of pharmacologic treatment, such as with sedative-hypnotics.
Insomnia can be a chronic problem for many older adults that leads to significant daytime fatigue, stress and numerous negative health consequences including depression. Advanced Medical Electronics, in partnership with researchers are the University of Pennsylvania and the Mayo Clinic, propose developing an innovative, non-drug, low-risk treatment that can be implemented on mobile devices for the treatment of insomnia in older adults.
