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Deep Sleep in Older Adults

NCT07316153 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-01-05

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Proactive Life Inc

    lead INDUSTRY

Principal Investigators

  • Daniel Taylor, PhD · University of Arizona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2026-12-30
Completion
2026-12-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07316153 on ClinicalTrials.gov