Generative AI for Sleep Promotion
20 juli 2026 uppdaterad av: 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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
60
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Liu
- Telefonnummer: 212-992-5994
- E-post: xl5272@nyu.edu
Studieorter
-
-
New York
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New York, New York, Förenta staterna, 10010
- Rekrytering
- New York University
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New York, New York, Förenta staterna, 10010
- Avslutad
- New York University
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Intervention
Participants will receive access to an AI-based chatbot and engage with it via text messaging for 2 weeks.
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Participants engage with an AI chatbot for two weeks to learn personalized education and skills regarding sleep promotion
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Aktiv komparator: 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.
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Participants engage with an AI chatbot for two weeks to learn personalized education and skills regarding sleep promotion
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Fitbit-measured sleep duration
Tidsram: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
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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.
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Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Fitbit-measured sleep onset
Tidsram: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
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Sleep onset will be measured objectively using Fitbit and defined as the time from attempting to fall asleep to sleep onset, expressed in minutes.
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Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
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Fitbit-measured sleep efficiency
Tidsram: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
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Sleep efficiency will be measured objectively using Fitbit and defined as the percentage of time spent asleep while in bed, expressed as a percentage (%).
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Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
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Fitbit-measured wake after sleep onset
Tidsram: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
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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.
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Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
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Perceived sleep quality
Tidsram: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
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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.
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Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
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Daytime sleepiness
Tidsram: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
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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.
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Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
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Sleep hygiene
Tidsram: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
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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).
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Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
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Sleep environment
Tidsram: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
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Sleep Environment measured by the Assessment of Sleep Environment
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Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
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Number of awakenings
Tidsram: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
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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.
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Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
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Light sleep duration
Tidsram: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
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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.
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Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
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Deep sleep duration
Tidsram: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
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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.
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Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
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Rapid eye movement sleep duration
Tidsram: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
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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.
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Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
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Wake duration
Tidsram: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
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Wake duration will be measured objectively using Fitbit and defined as the total time spent awake during the primary sleep period, expressed in minutes.
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Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
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Dysfunctional beliefs and attitudes about sleep
Tidsram: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
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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.
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Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
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Perceived stress
Tidsram: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
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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.
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Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
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Anxiety
Tidsram: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
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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.
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Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
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Fatigue
Tidsram: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
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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.
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Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
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Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
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Studera stora datum
Studiestart (Faktisk)
1 oktober 2025
Primärt slutförande (Beräknad)
1 juli 2027
Avslutad studie (Beräknad)
31 december 2027
Studieregistreringsdatum
Först inskickad
21 januari 2026
Först inskickad som uppfyllde QC-kriterierna
20 juli 2026
Första postat (Faktisk)
22 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
22 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- FY2024-9037
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
To protect participants' personal information and privacy
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
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Nej
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