NCT07316153

Deep Sleep in Older Adults

An Internet of Things Automated Cognitive Behavioral Therapy for Insomnia That Improves Cognition in Older Adults

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Proactive Life Inc · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 (IoT)-enabled environmental cues and artificial intelligence-driven personalization. The intervention is designed to promote adherence to CBT-I principles by passively supporting sleep-wake routines using adaptive sound, light, and behavioral prompts delivered through consumer electronic devices in the participant's home environment. The study is a randomized, double-blind, controlled trial conducted entirely remotely in community-dwelling older adults with clinically significant insomnia symptoms. Following screening and baseline assessment, participants are randomly assigned in equal allocation to one of three study arms: (1) an automated CBT-I system enhanced with IoT-based sound and light cues and personalized digital content, (2) an active digital CBT-I comparator, or (3) a sleep hygiene education active comparator condition. All participants receive comparable study devices and interaction time to maintain blinding and control for expectancy effects. The intervention period lasts six weeks and is preceded by a baseline assessment phase and followed by post-intervention and follow-up assessments. Throughout the study, participants complete standardized self-report measures of insomnia severity and engage in repeated, brief cognitive assessments administered via mobile devices. Objective sleep data are collected using non-invasive, ambulatory sensing technologies that operate passively in the home environment. The primary objective of the study is to compare changes in insomnia severity across study arms. Secondary objectives include evaluation of sleep characteristics, adherence to behavioral recommendations, and performance on cognitive tasks sensitive to sleep-related changes in older adults. The study is designed to assess feasibility, usability, and preliminary efficacy of an automated, home-based digital CBT-I approach that emphasizes adherence support and sleep quality enhancement. This trial will contribute evidence on whether an integrated digital and IoT-based behavioral intervention can improve insomnia outcomes and support cognitive functioning in older adults, informing future large-scale trials and potential clinical implementation.

Conditions

• Insomnia
• Insomnia Chronic

Interventions

Type	Name	Description
BEHAVIORAL	CBT-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.
BEHAVIORAL	SleepEZ CBTi	This condition includes interactive videos about CBT-I and leverages some IoT interventions.
BEHAVIORAL	Sleep Hygiene IoT	This intervention includes intractive videos regarding sleep hygiene, a component of CBT-I and leverages some IoT interventions.

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2026-01-05
• Last updated: 2026-01-05

Locations

1 site across 1 country: United States