Generative AI for Sleep Promotion
20. juli 2026 oppdatert 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.
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
60
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Liu
- Telefonnummer: 212-992-5994
- E-post: xl5272@nyu.edu
Studiesteder
-
-
New York
-
New York, New York, Forente stater, 10010
- Rekruttering
- New York University
-
New York, New York, Forente stater, 10010
- Fullført
- New York University
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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
|
|
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.
|
Participants engage with an AI chatbot for two weeks to learn personalized education and skills regarding sleep promotion
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Fitbit-measured sleep duration
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Fitbit-measured sleep onset
Tidsramme: 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
|
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Fitbit-measured sleep efficiency
Tidsramme: 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 (%).
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Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
|
|
Fitbit-measured wake after sleep onset
Tidsramme: 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
|
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Perceived sleep quality
Tidsramme: 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.
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Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
|
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Daytime sleepiness
Tidsramme: 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.
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Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
|
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Sleep hygiene
Tidsramme: 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).
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Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
|
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Sleep environment
Tidsramme: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
|
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
Tidsramme: 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
Tidsramme: 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
|
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Deep sleep duration
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
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Dysfunctional beliefs and attitudes about sleep
Tidsramme: 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
|
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Perceived stress
Tidsramme: 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
|
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Anxiety
Tidsramme: 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
|
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Fatigue
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. oktober 2025
Primær fullføring (Antatt)
1. juli 2027
Studiet fullført (Antatt)
31. desember 2027
Datoer for studieregistrering
Først innsendt
21. januar 2026
Først innsendt som oppfylte QC-kriteriene
20. juli 2026
Først lagt ut (Faktiske)
22. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- FY2024-9037
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
To protect participants' personal information and privacy
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