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NOT YET RECRUITING
NCT07316153
PHASE2

Deep Sleep in Older Adults

Sponsor: Proactive Life Inc

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2026-03-01

Completion Date

2026-12-30

Last Updated

2026-01-05

Healthy Volunteers

No

Interventions

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.

Locations (1)

SleepSpace

New York, New York, United States