Идёт набор NCT07718750

Generative AI for Sleep Promotion

Без фазы С лечением Sleep Problems

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: AI-based chatbot.
Кому может быть актуально: Состояния в реестре: Sleep Problems. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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.

Вмешательства

Поведенческое AI-based chatbot
Participants engage with an AI chatbot for two weeks to learn personalized education and skills regarding sleep promotion

Первичные конечные точки

Fitbit-measured sleep duration [Срок оценки: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups]

Вторичные конечные точки (12)

Fitbit-measured sleep onset [Срок оценки: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups]
Fitbit-measured sleep efficiency [Срок оценки: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups]
Fitbit-measured wake after sleep onset [Срок оценки: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups]
Perceived sleep quality [Срок оценки: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups]
Daytime sleepiness [Срок оценки: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups]
Sleep hygiene [Срок оценки: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups]
Sleep environment [Срок оценки: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups]
Number of awakenings [Срок оценки: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups]
Light sleep duration [Срок оценки: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups]
Deep sleep duration [Срок оценки: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups]
Rapid eye movement sleep duration [Срок оценки: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups]
Wake duration [Срок оценки: Baseline, 2-week post-intervention, and 3- and 6-month follow-ups]

Критерии участия

Критерии включения

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