# A non-pharmacological multi-modal therapy to improve sleep and cognition and reduce mild cognitive impairment risk

> **NIH NIH R44** · PROACTIVE LIFE, INC. · 2020 · $1,243,520

## Abstract

Summary
Our long-term goal is to improve healthcare with non-pharmacological interventions that use the science of behavior
change and new Internet of Things (IoT) devices to augment clinical treatment. When you go to the doctor of the
future, instead of prescribing a drug, in many cases the doctor may prescribe a software intervention guiding the
patient through a process of facilitated behavior change and environmental optimization. This software approach to
healthcare addresses the high-priority of providing services to individuals with limited/no access to care and for
addressing the public health issues of insomnia and conversion to Mild Cognitive Impairments (MCI) and Alzheimer's
Disease (AD). These diseases are thought to cost the US Healthcare system more than $400 billion/year, with
another $400 billion/year cost to U.S. businesses in lost productivity, sick days, and accidents. In our Phase I, we
were the first research group to show that non-phase locked auditory stimulation can improve next day performance
on attention measures without adversely impacting sleep organization, quality, or total sleep time. Our acoustic
intervention increased the percentage and intensity of slow-wave sleep (SWS), the stage of sleep with many
regenerative properties and which typically decreases with age. We have additional preliminary evidence that this
sound-based intervention, played at the right time and volume during sleep, can enhance next day memory
performance. Due to the accumulating support demonstrating the role that sleep quality and SWS play in conversion
to MCI and AD from imaging studies, longitudinal studies, and cognitive assessments, our intervention may address
both the public health issue of poor sleep quality and AD. In our Phase II, we propose to further address insomnia and
AD risk by integrating our deep sleep enhancement intervention and sound masking intervetinos with additional IoT
devices, such as the FitBit, Apple Watch, and Oura Ring for more accurately measuring sleep and delivering sleep
improvement enhancements, such as smart light bulbs to entrain and strengthen circadian rhythms, and Amazon's
Alexa to deliver relaxation interventions and reminders to address compliance. The developed software will include a
sleep diary with all relevant sleep statistics viewable by a trained therapist in the gold standard treatment for insomnia,
cognitive behavioral therapy for insomnia (CBTi). Displaying this data to the clinician can be used to deliver more
personalized interventions and increase compliance with the treatment. We propose to conduct a randomized clinical
trial on 65+ aged healthy individuals in an independent living facility that have symptoms for insomnia and compare
our enhanced type of CBTi integrated with new IoT technology to typical CBTi and a passive control of sleep hygiene
therapy. We hypothesize that our intervention is just as effective as the gold standard treatment for insomnia of CBTi
as measured by sleep ...

## Key facts

- **NIH application ID:** 10010093
- **Project number:** 2R44AG056250-03A1
- **Recipient organization:** PROACTIVE LIFE, INC.
- **Principal Investigator:** Daniel Gartenberg
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,243,520
- **Award type:** 2
- **Project period:** 2017-05-01 → 2022-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10010093

## Citation

> US National Institutes of Health, RePORTER application 10010093, A non-pharmacological multi-modal therapy to improve sleep and cognition and reduce mild cognitive impairment risk (2R44AG056250-03A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10010093. Licensed CC0.

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