AI-Powered sleep therapy could boost brain health in seniors

NCT ID NCT07316153

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

65 years and older

Sex

Anyone

Healthy volunteers

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

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.

Cognitive Dysfunction insomnia

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • SleepSpace

    New York, New York, 10012, United States

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