Generative AI for Sleep Promotion
20 juillet 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
60
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Liu
- Numéro de téléphone: 212-992-5994
- E-mail: xl5272@nyu.edu
Lieux d'étude
-
-
New York
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New York, New York, États-Unis, 10010
- Recrutement
- New York University
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New York, New York, États-Unis, 10010
- Complété
- New York University
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Intervention
Participants will receive access to an AI-based 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
|
|
Comparateur actif: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Fitbit-measured sleep duration
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Fitbit-measured sleep onset
Délai: 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
|
|
Fitbit-measured sleep efficiency
Délai: 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 (%).
|
Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
|
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Fitbit-measured wake after sleep onset
Délai: 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
|
|
Perceived sleep quality
Délai: 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
Délai: 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.
|
Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
|
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Sleep hygiene
Délai: 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).
|
Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
|
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Sleep environment
Délai: 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
Délai: 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
|
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Light sleep duration
Délai: 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
Délai: 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
|
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Rapid eye movement sleep duration
Délai: 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
|
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Wake duration
Délai: 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.
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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
Délai: 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.
|
Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
|
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Perceived stress
Délai: 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.
|
Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
|
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Anxiety
Délai: 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.
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Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
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Fatigue
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 octobre 2025
Achèvement primaire (Estimé)
1 juillet 2027
Achèvement de l'étude (Estimé)
31 décembre 2027
Dates d'inscription aux études
Première soumission
21 janvier 2026
Première soumission répondant aux critères de contrôle qualité
20 juillet 2026
Première publication (Réel)
22 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
22 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
20 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- FY2024-9037
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
To protect participants' personal information and privacy
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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