Remote CBT-I with IoT and AI for Insomnia in Older Adults
Official title: An Internet of Things Automated Cognitive Behavioral Therapy for Insomnia That Improves Cognition in Older Adults
Run by Proactive Life Inc · NCT07316153 · Data updated 2026-11-12
This trial tests if a fully remote, AI‑driven digital CBT‑I program with IoT environmental cues helps older adults with insomnia more than two active CBT‑I–based or sleep hygiene controls.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 55 Years and up |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | Proactive Life Inc Industry-sponsored |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Status | Recruiting |
| Started | September 30, 2026 |
| Main results expected | August 30, 2027 |
| Study ends | August 30, 2027 |
| Registry record updated | October 20, 2026 |
| Trial ID | NCT07316153 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 55+ with clinically significant insomnia symptoms (ISI ≥15, or ≥11 if recruitment is slow), fluent in English, capable of consent, and living independently.
✕Probably not a fit
Individuals with conditions causing sleep disruption other than insomnia (e.g., untreated sleep apnea) or those unable to use digital/mobile technologies may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 2, randomized, double‑blind trial studies a remote digital CBT‑I system that uses IoT devices and AI personalization to support sleep in community‑dwelling adults aged 55 and older with insomnia symptoms. Participants are assigned to one of three arms: SleepSpaceRx CBT‑I‑IoT‑AI, SleepEZ CBT‑I–based active comparator, or Sleep Hygiene with IoT as an active control, with blinding maintained through similar device interaction. The primary outcome is Insomnia Severity Index, while secondary outcomes include objective and subjective sleep metrics and cognitive performance measures. Recruitment targets 180 participants across the three arms, with remote screening and assessment to facilitate accessibility for older adults. The study aims to determine if automated, ambient support can improve adherence and efficacy of CBT‑I in real‑world settings.
Why it matters
Potential benefit: If successful, participants may experience greater improvement in insomnia symptoms and daytime functioning through a scalable, fully remote therapy personalized by AI.
How similar studies have gone: Digital CBT‑I approaches with remote delivery show promise, but combining IoT cues and AI personalization in an entirely remote trial is relatively novel and aims to overcome adherence barriers.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria
1. Fluent English speaker and reader.
2. Capable of providing one's own informed consent.
1. 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).
3. Age 55+ years old (inclusive) at enrollment. a. As self-reported on screening survey and later verified in video appointment (e.g. Zoom Health)
4. 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).
1. As self-reported on screening survey
5. 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
6. 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.
a. By self-report
7. Willing to maintain any existing physician-directed pharmacologic intervention for issues pertaining to sleep for the duration of study participation.
a. By self-report
8. Has a residence with WIFI.
a. By self-report
9. Normal hearing with or without a hearing aid.
a. By self-report
10. Difficulty falling asleep, staying asleep, or waking too early, occurring at least 3 nights/week for 3+months, causing significant daytime distress/impairment (e.g., fatigue, poor focus, mood issues), despite adequate sleep opportunity, and not better explained by another sleep disorder or substance.
1. By Sleep Condition Indicator \[SCI\]
Exclusion Criteria
1. 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.
2. Diagnosed serious mental health disorder.
1. Specifically, psychosis or bipolar depression, severe major depression, moderate to high risk of suicide, dementia
2. As self-reported on screening survey
3. 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
4. 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.
5. Initiation of any psychological treatment in the last 3-months.
6. A highly irregular schedule (e.g. shift work) that would prevent adoption of intervention strategies, as evaluated through the Shift Work Disorder Index.
7. Previous exposure to the SleepSpace software.
8. Medical conditions that are exacerbated by sleep restriction.
9. Planned major surgery during the trial.
Where it's running
-
SleepSpace
New York, New York, United States Recruiting -
SleepSpace
New York, New York, United States Recruiting
Study contacts
- Study coordinator: Daniel Gartenberg, PhD
- Email: dan@sleepspace.com
- Phone: 732-668-1250
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.