Sleep ProblemsNCT07718750
Generative AI for Sleep Promotion
A study testing AI-based chatbot in people with Sleep Problems, run by New York University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sleep Problems
- What is being tested?
- AI-based chatbot
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- pregnant or lactating
- concurrently participating in other research studies focused on lifestyle modifications
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Completed
New York University
New York, New York, 10010
- Recruiting
New York University
New York, New York, 10010
About this study
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.
Read the 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.
- Conditions
- Sleep Problems
- Being tested
- AI-based chatbot
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-based chatbotBehavioural
Participants engage with an AI chatbot for two weeks to learn personalized education and skills regarding sleep promotion
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will receive access to an AI-based chatbot and engage with it via text messaging for 2 weeks. Receives: 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. Receives: Behavioral: AI-based chatbot |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
Secondary outcomes (16)
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.
Measured: 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 (%).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
Sleep environment
Sleep Environment measured by the Assessment of Sleep Environment
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start1 Oct 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ProblemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07718750
- Sponsor's protocol ID
- FY2024-9037
- Status last verified
- Jul 2026
- First submitted
- 21 Jan 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect participants' personal information and privacy
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generative AI for Sleep Promotion
- ClinicalTrials.gov ID
- NCT07718750
- Acronym / sponsor ID
- FY2024-9037
- Conditions
- Sleep Problems
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: AI-based chatbotParticipants will receive access to an AI-based chatbot and engage with it via text messaging for 2 weeks. |
| Waitlist control | Active comparator | Behavioral: AI-based chatbotParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- pregnant or lactating
- concurrently participating in other research studies focused on lifestyle modifications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-based chatbotParticipants engage with an AI chatbot for two weeks to learn personalized education and skills regarding sleep promotion | Behavioural | Intervention, Waitlist control |
Primary outcome
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.
16 secondary outcomes
Fitbit-measured sleep onset
Time frame: 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
Fitbit-measured wake after sleep onset
Time frame: 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
Daytime sleepiness
Time frame: 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 environment
Time frame: 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
Light sleep duration
Time frame: 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
Rapid eye movement sleep duration
Time frame: 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
Dysfunctional beliefs and attitudes about sleep
Time frame: 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
Anxiety
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No. To protect participants' personal information and privacy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-based chatbot in people with Sleep Problems, run by New York University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liu (212-992-5994, xl5272@nyu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fitbit-measured sleep duration (time frame: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.