AI-Powered sleep therapy could boost brain health in seniors
NCT ID NCT07316153
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a high-tech version of cognitive behavioral therapy for insomnia (CBT-I) in adults aged 65 and older. It uses smart devices, sensors, and artificial intelligence to personalize sleep coaching at home. Researchers will compare it to simpler digital sleep programs to see if it improves sleep quality and thinking skills.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cognitive behavioral therapy for insomnia (CBT-I) enhanced with Internet of Things devices and artificial intelligence
- What this could lead to
- If successful, this approach could provide a more accessible, personalized, and effective way to treat insomnia in older adults, potentially improving both sleep and cognitive function.
- What could go wrong
- This is an early phase 2 trial with only 180 participants, so results may not apply to everyone. The technology is complex and may not work better than simpler alternatives.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 180 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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65 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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. 1. 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). a. 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. 1. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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SleepSpace
New York, New York, 10012, United States
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