Generative AI for Sleep Promotion

July 20, 2026 updated by: New York University
Sleep is a major public health concern in the United States. Major guidelines recommend that adults obtain at least 7 hours of sleep per night. More than 25% of U.S. adults do not meet this recommendation, and 14.5% report difficulty falling asleep on most days or every day during the past month. The investigators developed a low-cost, easily accessible sleep intervention using artificial intelligence (AI) technologies. The purpose of this study is to examine the effect of this intervention on sleep outcomes among U.S. adults.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

After providing informed consent, participants will complete a baseline assessment and then be randomized to either the AI chatbot intervention or a waitlist control. The intervention group will receive immediate access to the AI-powered sleep chatbot for 2 weeks, while the waitlist control group will continue their usual sleep habits without chatbot access. Following the post-intervention assessment, participants in the waitlist control group will receive access to the chatbot. Follow-up assessments will be conducted at 3 and 6 months after randomization.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10010
        • Recruiting
        • New York University
      • New York, New York, United States, 10010
        • Completed
        • New York University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 18-75 years
  • had a raw score of 23 or higher on the Patient-Reported Outcomes Measurement Information System (PROMIS™) Sleep Disturbance
  • had a smartphone and be able to access the internet
  • willing and able to participate through text messages on a smartphone
  • able to read and understand English

Exclusion Criteria:

  • pregnant or lactating
  • concurrently participating in other research studies focused on lifestyle modifications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
Participants will receive access to an AI-based chatbot and engage with it via text messaging for 2 weeks.
Behavioral: AI-based chatbot
Participants engage with an AI chatbot for two weeks to learn personalized education and skills regarding sleep promotion
Active Comparator: Waitlist control
Participants will continue their usual sleep habits for 2 weeks without access to the AI-based chatbot. After the 2-week waitlist period, participants will receive access to the chatbot and engage with it via text messaging for 2 weeks.
Behavioral: AI-based chatbot
Participants engage with an AI chatbot for two weeks to learn personalized education and skills regarding sleep promotion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fitbit-measured sleep duration
Time Frame: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
Sleep duration will be measured objectively using Fitbit and defined as the total amount of time spent asleep during the primary sleep period, expressed in minutes.
Baseline, 2-week post-intervention, and 3- and 6-month follow-ups

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fitbit-measured sleep onset
Time Frame: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
Sleep onset will be measured objectively using Fitbit and defined as the time from attempting to fall asleep to sleep onset, expressed in minutes.
Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
Fitbit-measured sleep efficiency
Time Frame: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
Sleep efficiency will be measured objectively using Fitbit and defined as the percentage of time spent asleep while in bed, expressed as a percentage (%).
Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
Fitbit-measured wake after sleep onset
Time Frame: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
Wake after sleep onset will be measured objectively using Fitbit and defined as the total amount of time participants are awake after initially falling asleep until the final awakening, expressed in minutes.
Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
Perceived sleep quality
Time Frame: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
Perceived sleep quality measured by the Pittsburgh Sleep Quality Index. The total score ranges from 0 to 21, with higher scores indicating worse sleep quality.
Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
Daytime sleepiness
Time Frame: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
Daytime sleepiness will be measured using the Epworth Sleepiness Scale. The total score ranges from 0 to 24, with higher scores indicating greater daytime sleepiness.
Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
Sleep hygiene
Time Frame: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
Sleep hygiene will be measured using the Sleep Hygiene Index. The total score ranges from 13 to 65, with a higher score indicating poorer sleep hygiene (a worse outcome).
Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
Sleep environment
Time Frame: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
Sleep Environment measured by the Assessment of Sleep Environment
Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
Number of awakenings
Time Frame: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
Number of awakenings will be measured objectively using Fitbit and defined as the total number of wake episodes occurring during the primary sleep period, expressed as the number of awakenings.
Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
Light sleep duration
Time Frame: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
Light sleep duration will be measured objectively using Fitbit and defined as the total time spent in the light sleep stage during the primary sleep period, expressed in minutes.
Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
Deep sleep duration
Time Frame: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
Deep sleep duration will be measured objectively using Fitbit and defined as the total time spent in the deep sleep stage during the primary sleep period, expressed in minutes.
Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
Rapid eye movement sleep duration
Time Frame: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
Rapid eye movement sleep duration will be measured objectively using Fitbit and defined as the total time spent in the rapid eye movement sleep stage during the primary sleep period, expressed in minutes.
Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
Wake duration
Time Frame: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
Wake duration will be measured objectively using Fitbit and defined as the total time spent awake during the primary sleep period, expressed in minutes.
Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
Dysfunctional beliefs and attitudes about sleep
Time Frame: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
Dysfunctional beliefs and attitudes about sleep will be measured using the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16). The total scores range from 0 to 10, with a higher score indicating more dysfunctional beliefs and attitudes about sleep.
Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
Perceived stress
Time Frame: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
Perceived stress will be measured using the Perceived Stress Scale-4. The total score ranges from 0 to 16, with a higher score indicating greater perceived stress.
Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
Anxiety
Time Frame: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
Anxiety will be measured using the Generalized Anxiety Disorder-2. The total score ranges from 0 to 6, with a higher score indicating greater anxiety symptom severity.
Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
Fatigue
Time Frame: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
Fatigue will be measured using the Fatigue Severity Scale. The total score ranges from 1 to 7, with a higher score indicating greater fatigue severity.
Baseline, 2-week post-intervention, and 3- and 6-month follow-ups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
New York University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FY2024-9037

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To protect participants' personal information and privacy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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