NCT07316153 · Proactive Life Inc
Deep Sleep in Older Adults
What this study is about
This double blind randomly assigned 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 \[AI\]).
View original scientific description
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.
Interventions
BEHAVIORAL
SleepSpaceRx CBT-I-IoT-AI
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.
BEHAVIORAL
SleepEZ CBTi
This condition includes interactive videos about CBT-I and leverages some IoT interventions.
BEHAVIORAL
Sleep Hygiene IoT
This intervention includes intractive videos regarding sleep hygiene, a component of CBT-I and leverages some IoT interventions.
Primary outcome measures
Insomnia Severity Index (ISI)
Time frame: Weekly for the first 8 weeks, then at week 10 and week 12
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 55+ years old (inclusive) at enrollment. a. 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).
- 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. a. 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
- Normal hearing with or without a hearing aid. a. By self-report
- 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.
- By Sleep Condition Indicator \[SCI\]
Exclusion criteria
- 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.
Where
- New York, New York
Collaborators
National Institute on Aging (NIA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 2, 2026 · Source of record for eligibility and locations