- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07718750
Generative AI for Sleep Promotion
2026년 7월 20일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
60
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Liu
- 전화번호: 212-992-5994
- 이메일: xl5272@nyu.edu
연구 장소
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New York
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New York, New York, 미국, 10010
- 모병
- New York University
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New York, New York, 미국, 10010
- 완전한
- New York University
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Fitbit-measured sleep duration
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Fitbit-measured sleep onset
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2025년 10월 1일
기본 완료 (추정된)
2027년 7월 1일
연구 완료 (추정된)
2027년 12월 31일
연구 등록 날짜
최초 제출
2026년 1월 21일
QC 기준을 충족하는 최초 제출
2026년 7월 20일
처음 게시됨 (실제)
2026년 7월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 22일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 20일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .