New York, NYNCT07316153Now EnrollingIRB Ready

Insomnia Clinical Trial in New York, NY

Access cutting-edge insomnia treatment through this phase 2 clinical trial at a research site in New York. Study-provided care at no cost to qualified participants.

Sponsored by Proactive Life Inc

Quick Self-Assessment

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Expert Care in New York

Access insomnia specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related insomnia treatment provided free

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Check if you qualify for this insomnia clinical trial in New York, NY

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to New York

    Convenient for NY residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit New York site if eligible
  4. 4Begin participation

About This Insomnia Study in New York

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.

Sponsor: Proactive Life Inc

Who Can Participate

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New York?

Yes, this clinical trial (NCT07316153) has an active research site in New York, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Insomnia Treatment Options in New York, NY

If you're searching for insomnia treatment options in New York, NY, this clinical trial (NCT07316153) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New York research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced insomnia specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all insomnia clinical trials near you to find additional studies recruiting in your area.

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