Generative AI for Sleep Promotion
20 lipca 2026 zaktualizowane przez: 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.
Przegląd badań
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Szacowany)
60
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Liu
- Numer telefonu: 212-992-5994
- E-mail: xl5272@nyu.edu
Lokalizacje studiów
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New York
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New York, New York, Stany Zjednoczone, 10010
- Rekrutacyjny
- New York University
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New York, New York, Stany Zjednoczone, 10010
- Zakończony
- New York University
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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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Aktywny 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Fitbit-measured sleep duration
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Fitbit-measured sleep onset
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
1 października 2025
Zakończenie podstawowe (Szacowany)
1 lipca 2027
Ukończenie studiów (Szacowany)
31 grudnia 2027
Daty rejestracji na studia
Pierwszy przesłany
21 stycznia 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
20 lipca 2026
Pierwszy wysłany (Rzeczywisty)
22 lipca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
22 lipca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
20 lipca 2026
Ostatnia weryfikacja
1 lipca 2026
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- FY2024-9037
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Opis planu IPD
To protect participants' personal information and privacy
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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