[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07718750":3,"trial-entities:NCT07718750":127,"trial-summary:NCT07718750":131},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":35,"secondary_outcomes":40,"sex":89,"minimum_age":90,"maximum_age":91,"healthy_volunteers":92,"eligibility_criteria":93,"std_ages":104,"locations":107,"central_contacts":118,"overall_officials":124,"references":125,"see_also_links":126},"NCT07718750","FY2024-9037","Generative AI for Sleep Promotion","RECRUITING","2027-12-31","2026-07","2026-07-22","2025-10-01","New York University","OTHER",null,"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.","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.",[18],"Sleep Problems",[],"INTERVENTIONAL","PREVENTION",[23],"NA",{"count":25,"type":26},60,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"BEHAVIORAL","AI-based chatbot","Participants engage with an AI chatbot for two weeks to learn personalized education and skills regarding sleep promotion",[33,34],"Intervention","Waitlist control",[36],{"measure":37,"description":38,"timeFrame":39},"Fitbit-measured sleep duration","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",[41,44,47,50,53,56,59,62,65,68,71,74,77,80,83,86],{"measure":42,"description":43,"timeFrame":39},"Fitbit-measured sleep onset","Sleep onset will be measured objectively using Fitbit and defined as the time from attempting to fall asleep to sleep onset, expressed in minutes.",{"measure":45,"description":46,"timeFrame":39},"Fitbit-measured sleep efficiency","Sleep efficiency will be measured objectively using Fitbit and defined as the percentage of time spent asleep while in bed, expressed as a percentage (%).",{"measure":48,"description":49,"timeFrame":39},"Fitbit-measured wake after sleep onset","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.",{"measure":51,"description":52,"timeFrame":39},"Perceived sleep quality","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.",{"measure":54,"description":55,"timeFrame":39},"Daytime sleepiness","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.",{"measure":57,"description":58,"timeFrame":39},"Sleep hygiene","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).",{"measure":60,"description":61,"timeFrame":39},"Sleep environment","Sleep Environment measured by the Assessment of Sleep Environment",{"measure":63,"description":64,"timeFrame":39},"Number of awakenings","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.",{"measure":66,"description":67,"timeFrame":39},"Light sleep duration","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.",{"measure":69,"description":70,"timeFrame":39},"Deep sleep duration","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.",{"measure":72,"description":73,"timeFrame":39},"Rapid eye movement sleep duration","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.",{"measure":75,"description":76,"timeFrame":39},"Wake duration","Wake duration will be measured objectively using Fitbit and defined as the total time spent awake during the primary sleep period, expressed in minutes.",{"measure":78,"description":79,"timeFrame":39},"Dysfunctional beliefs and attitudes about sleep","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.",{"measure":81,"description":82,"timeFrame":39},"Perceived stress","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.",{"measure":84,"description":85,"timeFrame":39},"Anxiety","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.",{"measure":87,"description":88,"timeFrame":39},"Fatigue","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.","ALL","18 Years","75 Years",false,{"inclusion":94,"exclusion":100,"raw_text":103},[95,96,97,98,99],"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",[101,102],"pregnant or lactating","concurrently participating in other research studies focused on lifestyle modifications","Inclusion Criteria:\n\n* Aged 18-75 years\n* had a raw score of 23 or higher on the Patient-Reported Outcomes Measurement Information System (PROMIS™) Sleep Disturbance\n* had a smartphone and be able to access the internet\n* willing and able to participate through text messages on a smartphone\n* able to read and understand English\n\nExclusion Criteria:\n\n* pregnant or lactating\n* concurrently participating in other research studies focused on lifestyle modifications",[105,106],"ADULT","OLDER_ADULT",[108,116],{"facility":12,"status":109,"city":110,"state":110,"zip":111,"country":112,"geoPoint":113},"COMPLETED","New York","10010","United States",{"lat":114,"lon":115},40.71427,-74.00597,{"facility":12,"status":7,"city":110,"state":110,"zip":111,"country":112,"geoPoint":117},{"lat":114,"lon":115},[119],{"name":120,"role":121,"phone":122,"email":123},"Liu","CONTACT","212-992-5994","xl5272@nyu.edu",[],[],[],{"nct_id":4,"conditions":128,"biomarkers":130},[129],"Dyssomnia",[],{"nct_id":4,"found":132,"summary":133,"prompt_version":142},true,{"design":134,"status":135,"heading":6,"summary":136,"follow_up":137,"word_count":138,"commitments":139,"compensation":140,"drugs_mentioned":141},"This is an interventional study planning to enroll 60 participants. You will be randomly assigned to either use the AI chatbot right away or be in a waitlist control group.","completed","This study is testing an AI-based chatbot to help adults with sleep problems. The chatbot provides personalized education and skills to improve sleep. To join, you must be between 18 and 75 years old, have significant sleep disturbance (a PROMIS™ Sleep Disturbance score of 23 or higher), own a smartphone with internet access, and be able to read and understand English. The main goal is to see if using the AI chatbot improves how long you sleep, measured by a Fitbit, at different times over six months. The current status of this study is unclear.","You will be followed for 3 and 6 months after being assigned to a group.",95,"You will complete a baseline assessment, then use the AI chatbot for two weeks if in the intervention group. Follow-up assessments will be done at 3 and 6 months after you start the study.","Not stated in the trial record.",[30],"v2"]