An Internet of Things Automated Cognitive Behavioral Therapy for Insomnia That Improves Cognition in Older Adults
Proactive Life Inc
Summary
This double blind randomized clinical trial on older independent-living healthy individuals with symptoms of insomnia will harness Cognitive Behavioral Therapy for Insomnia (CBT-I) and augment it with ambulatory data collection devices, personalized digital content, and smart sound and light cues (CBT-I +Internet of Things \[IoT\]+Artificial Intelligence \[AI\]). With this approach, the investigators aim to overcome many of the limitations that CBT-I in the clinic faces: the investigators can implement it in ambulatory settings while providing increased (remote) accessibility to therapy. The investigators will compare the CBT-I +IoT+AI to active controls that also integrate with smart phone devices, including SleepEZ, which is also based on CBT-I, and sleep hygiene education. These active controls will help determine whether CBT-I +IoT+AI is effective at treating insomnia based on the Insomnia Severity Index (ISI) (primary outcome), sleep metrics (secondary outcome), cognitive performance (secondary outcome), and additional outcomes like therapeutic adherence and other mental health assessments. Participants will be asked to track sleep with wearable and nearable devices, complete surveys, and complete cognitive assessments.
Description
Insomnia is highly prevalent in older adults and is associated with impaired daytime functioning and increased risk for cognitive decline. Cognitive Behavioral Therapy for Insomnia (CBT-I) is the recommended first-line treatment, yet access, adherence, and scalability remain persistent barriers, particularly for older populations. Digital CBT-I programs address some access challenges but often demonstrate reduced adherence and diminished effectiveness in real-world use. This study evaluates a fully remote, automated digital CBT-I system that integrates mobile software with Internet of Things…
Eligibility
- Age range
- 65+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria 1. Fluent English speaker and reader. 2. Capable of providing one's own informed consent. 1. As determined by validated, abbreviated phone-based remote Montreal Cognitive Assessment (MoCA) testing score of ≥18, which is the score that separates Mild Cognitive Impairment (MCI) from Alzheimer's Disease and Related Dementia (ADRD). 3. Age 65+ years old (inclusive) at enrollment, but if recruitment is slow, the investigators may adjust the criteria to 60+, and if it is still slow, it could go as low as 55+ years old. 1. As self-reported on screening survey and later ver…
Interventions
- BehavioralCBT-I-IoT-AI
What distinguishes this condition is increased customization of the CBT-I content and increased usage of the Internet of Things (IoT) devices used to promote CBT-I directives.
- BehavioralSleepEZ CBTi
This condition includes interactive videos about CBT-I and leverages some IoT interventions.
- BehavioralSleep Hygiene IoT
This intervention includes intractive videos regarding sleep hygiene, a component of CBT-I and leverages some IoT interventions.
Location
- SleepSpaceNew York, New York