Generative AI for Sleep Promotion

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: Recruiting
• Conditions: Sleep Problems
• Intervention / Treatment: Behavioral: AI-based chatbot

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: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liu; Phone Number: 212-992-5994; Email: xl5272@nyu.edu

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Fitbit-measured sleep duration	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

Outcome Measure	Measure Description	Time Frame
Fitbit-measured sleep onset	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	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	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	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	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	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	Sleep Environment measured by the Assessment of Sleep Environment	Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
Number of awakenings	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	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	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	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	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	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	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	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	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

• Sponsor: New York University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: January 21, 2026
• First Submitted That Met QC Criteria: July 20, 2026
• First Posted (Actual): July 22, 2026

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Parasomnias
• Other Study ID 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