Generative AI for Sleep Promotion

NCT07718750 | Recruiting

• 1 other identifier: FY2024-9037
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Sleep Problems

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Fitbit-measured sleep onset

  Baseline, 2-week post-intervention, and 3- and 6-month follow-ups

• Fitbit-measured sleep efficiency

  Baseline, 2-week post-intervention, and 3- and 6-month follow-ups

• Fitbit-measured wake after sleep onset

  Baseline, 2-week post-intervention, and 3- and 6-month follow-ups

• Perceived sleep quality

  Baseline, 2-week post-intervention, and 3- and 6-month follow-ups

• Daytime sleepiness

  Baseline, 2-week post-intervention, and 3- and 6-month follow-ups

Study Arms (2)

Intervention

EXPERIMENTAL

Participants will receive access to an AI-based chatbot and engage with it via text messaging for 2 weeks.

Behavioral: AI-based chatbot

Waitlist control

ACTIVE COMPARATOR

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

Interventions

AI-based chatbot BEHAVIORAL

Participants engage with an AI chatbot for two weeks to learn personalized education and skills regarding sleep promotion

Intervention; Waitlist control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• New York University: lead

Study Sites (2)

New York University

New York, New York, 10010, United States

COMPLETED

New York University

New York, New York, 10010, United States

RECRUITING

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Liu

CONTACT

212-992-5994; xl5272@nyu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: July 22, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)