Generative AI for Sleep Promotion
20. Juli 2026 aktualisiert von: 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.
Studienübersicht
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Geschätzt)
60
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Liu
- Telefonnummer: 212-992-5994
- E-Mail: xl5272@nyu.edu
Studienorte
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New York
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New York, New York, Vereinigte Staaten, 10010
- Rekrutierung
- New York University
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New York, New York, Vereinigte Staaten, 10010
- Abgeschlossen
- New York University
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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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Aktiver 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Fitbit-measured sleep duration
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Fitbit-measured sleep onset
Zeitfenster: 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.
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Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
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Fitbit-measured sleep efficiency
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. Oktober 2025
Primärer Abschluss (Geschätzt)
1. Juli 2027
Studienabschluss (Geschätzt)
31. Dezember 2027
Studienanmeldedaten
Zuerst eingereicht
21. Januar 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
20. Juli 2026
Zuerst gepostet (Tatsächlich)
22. Juli 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
22. Juli 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
20. Juli 2026
Zuletzt verifiziert
1. Juli 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- FY2024-9037
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Beschreibung des IPD-Plans
To protect participants' personal information and privacy
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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