Deep Sleep in Older Adults

NCT07316153 | Not Yet Recruiting Phase 2

• 1 other identifier: 1R43AG097205-01
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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

Insomnia; Insomnia Chronic

Keywords

cognitive behavioral therapy; internet of things; wearables; insomnia; older adults; cognitive impairment; cognition

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity Index (ISI)

  Subjective patient completion of the Insomnia Severity Index survey. Sum of survey item responses; Minimum score: 0; Maximum score: 28. Higher sum score indicates a greater number of, or more severe, insomnia symptoms; reduction in sum score suggests improvement of insomnia.

  Weekly for the first 8 weeks, then at week 10 and week 12

Secondary Outcomes (2)

• Change in cognitive test battery performance

  Daily for two weeks at baseline and two weeks post treatment

• Consensus Sleep Diary

  Daily for the first eight weeks of the trial

Other Outcomes (9)

• Nearable Sleep Sensing (Motion)

  Daily from week two to week eight

• Nearable Sleep Sensing (Sound)

  Daily from week two to week eight

• Wearable Sleep Sensing (Motion)

  Daily from week two to week eight

Study Arms (3)

CBT-I-IoT-AI

EXPERIMENTAL

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.

Behavioral: CBT-I-IoT-AI

Sleep-EZ CBT-I Based Solution

ACTIVE COMPARATOR

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.

Behavioral: SleepEZ CBTi

Sleep Hygiene + IoT

ACTIVE COMPARATOR

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.

Behavioral: Sleep Hygiene IoT

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.

CBT-I-IoT-AI

SleepEZ CBTi BEHAVIORAL

This condition includes interactive videos about CBT-I and leverages some IoT interventions.

Sleep-EZ CBT-I Based Solution

Sleep Hygiene IoT BEHAVIORAL

This intervention includes intractive videos regarding sleep hygiene, a component of CBT-I and leverages some IoT interventions.

Sleep Hygiene + IoT

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Fluent English speaker and reader.
• Capable of providing one's own informed consent.
• 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).
• 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.
• As self-reported on screening survey and later verified in video appointment (e.g. Zoom Health)
• If residing in a community residence (such as a retirement community) in which a Medical Director designates living status categories, then the participant must be Independent Living status (or equivalent).
• a. As self-reported on screening survey
• Insomnia Severity Index score ≥15 (i.e., at least "clinical insomnia," that is "moderate-to-severe") - but if recruitment is slow then the investigators will recruit with ISI score ≥11 "mild-to-severe").
• a. As self-reported on the ISI screening survey
• Willing to refrain from initiating new therapeutic interventions (e.g. medication; behavioral) that are not a part of this study protocol for issues pertaining to sleep for the duration of study participation.
• By self-report
• Willing to maintain any existing physician-directed pharmacologic intervention for issues pertaining to sleep for the duration of study participation.
• a. By self-report
• Has a residence with WIFI.
• a. By self-report

You may not qualify if:

• Illicit drug use in the past month (except for marijuana because it is legal in many States, and the investigators are recruiting nationwide).
• a. As self-reported on screening survey. Marijuana usage will be tracked via self-report and examined as a moderator.
• Diagnosed serious mental health disorder.
• Specifically, psychosis or bipolar depression, severe major depression, moderate to high risk of suicide, dementia
• As self-reported on screening survey
• Currently or recent engaged (past 1-year) in evidence-based psychotherapy for Insomnia (e.g., CBTi), in addition to ever receiving a full course of CBTi:
• a. By self-report
• Cohabitating with a current or previous participant in this study.
• a. This criterion is to avoid cross-contamination of study condition awareness, if two cohabitating individuals are randomized into different study arms.
• Initiation of any psychological treatment in the last 3-months.
• A highly irregular schedule (e.g. shift work) that would prevent adoption of intervention strategies, as evaluated through the Shift Work Disorder Index.
• Previous exposure to the SleepSpace software.
• Medical conditions that are exacerbated by sleep restriction.
• Planned major surgery during the trial.

Sponsors & Collaborators

• Proactive Life Inc: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

SleepSpace

New York, New York, 10012, United States

Location

Related Links

• Company Website

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Study Officials

• Daniel Taylor, PhD

  University of Arizona

  STUDY DIRECTOR

Central Study Contacts

Daniel Gartenberg, PhD

CONTACT

732-668-1250; dan@sleepspace.com

Melissa Markovitz

CONTACT

9177571660; mel@sleepspace.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CEO

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 5, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)