Deep Sleep in Older Adults

Conditions

• Insomnia
• Insomnia Chronic

Eligibility Criteria

Sex

ALL

Age

65 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Mar 1, 2026

Status verified

Dec 2025

Primary completion

Dec 30, 2026

Completion

Dec 30, 2026

Study Design

Enrollment

180 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: CBT-I-IoT-AI
  Participants randomized to this study arm will experience an attempted enhancement of standard video based digital CBT-I, that is facilitated with electronic device-based interventions (Internet of Things) and artificial intelligence (AI) customizations of content. Noninvasive ambulatory worn + bedside devices deliver real-time feedback of objective data to the participant on an application interface and this data is used to customize the software and promote healthy sleep routines. In addition, daily animated videos are customized to the users' challenges. Subjective data collected using the application are available live to the participant, when appropriate. Environmental cues and notifications are programmed into IoT devices to remind patients of their behavioral prescription and to create a living-space environment that is conducive to effective therapy. This will include smart lights and sounds that cue the participant.
• Active Comparator: Sleep-EZ CBT-I Based Solution
  Participants randomized to this study arm will experience standard digital-based CBT-I that is delivered via the Path to Better Sleep program called SleepEZ that was created by Veteran Affairs (VA). The program will be administered within the SleepSpace software, which will be used to track adherence and deliver sham interventions. Users will have access to a pared-down version of the SleepSpace electronic application that enables them to track sleep in a sleep diary, access the content found in SleepEZ, and integrate with smart light bulbs and sounds to receive certain sound and light interventions. For example, the lights will brighten during the users expected circadian dip.
• Active Comparator: Sleep Hygiene + IoT
  Participants randomized to this study arm will experience sleep hygiene education and training, a component of CBT-I, which will also occur within the SleepSpace software to ensure all participants receive the same software platform and adherence is tracked uniformly across solutions. Users will have access to a version of our electronic application that enables them to track sleep in a sleep diary, access the animated Sleep Hygiene content created in the same way as the videos in the CBTi-IoT-AI condition, and integrate with smart light bulbs and sounds to receive certain sound and light interventions.

Primary Outcome Measure

Insomnia Severity Index (ISI) [ Time Frame: Weekly for the first 8 weeks, then at week 10 and week 12 ]

Central Contacts

• Daniel Gartenberg, PhD
  732-668-1250
  [email protected]
• Melissa Markovitz
  9177571660
  [email protected]

Locations (1)

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