Generative AI for Sleep Promotion
2026年7月20日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
60
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Liu
- 電話番号：212-992-5994
- メール：xl5272@nyu.edu
研究場所
-
-
New York
-
New York、New York、アメリカ、10010
- 募集
- New York University
-
New York、New York、アメリカ、10010
- 完了
- New York University
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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
|
|
アクティブコンパレータ：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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Fitbit-measured sleep duration
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Fitbit-measured sleep onset
時間枠：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
時間枠：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
|
|
Fitbit-measured wake after sleep onset
時間枠：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
時間枠：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.
|
Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
|
|
Daytime sleepiness
時間枠：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
|
|
Sleep hygiene
時間枠：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
|
|
Sleep environment
時間枠：Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
|
Sleep Environment measured by the Assessment of Sleep Environment
|
Baseline, 2-week post-intervention, and 3- and 6-month follow-ups
|
|
Number of awakenings
時間枠：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
時間枠：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
|
|
Deep sleep duration
時間枠：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
時間枠：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
時間枠：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
|
|
Dysfunctional beliefs and attitudes about sleep
時間枠：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
|
|
Perceived stress
時間枠：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
|
|
Anxiety
時間枠：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
|
|
Fatigue
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2025年10月1日
一次修了 (推定)
2027年7月1日
研究の完了 (推定)
2027年12月31日
試験登録日
最初に提出
2026年1月21日
QC基準を満たした最初の提出物
2026年7月20日
最初の投稿 (実際)
2026年7月22日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月22日
QC基準を満たした最後の更新が送信されました
2026年7月20日
最終確認日
2026年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。