[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617248":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":39,"centralContacts":44,"locations":54,"responsibleParty":70,"collaborators":74,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":30,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":30,"enrollmentInfo":87,"targetDuration":30,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":97,"overallStatus":105,"whyStopped":30,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Proactive Life Inc","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"CBT-I-IoT-AI","EXPERIMENTAL","Participants randomized to this study arm will experience an attempted enhancement of standard video based digital CBT-I, that is facilitated with electronic device-based interventions (Internet of Things) and artificial intelligence (AI) customizations of content. Noninvasive ambulatory worn + bedside devices deliver real-time feedback of objective data to the participant on an application interface and this data is used to customize the software and promote healthy sleep routines. In addition, daily animated videos are customized to the users' challenges. Subjective data collected using the application are available live to the participant, when appropriate. Environmental cues and notifications are programmed into IoT devices to remind patients of their behavioral prescription and to create a living-space environment that is conducive to effective therapy. This will include smart lights and sounds that cue the participant.",[13],"Behavioral: CBT-I-IoT-AI",{"label":15,"type":16,"description":17,"interventionNames":18},"Sleep-EZ CBT-I Based Solution","ACTIVE_COMPARATOR","Participants randomized to this study arm will experience standard digital-based CBT-I that is delivered via the Path to Better Sleep program called SleepEZ that was created by Veteran Affairs (VA). The program will be administered within the SleepSpace software, which will be used to track adherence and deliver sham interventions. Users will have access to a pared-down version of the SleepSpace electronic application that enables them to track sleep in a sleep diary, access the content found in SleepEZ, and integrate with smart light bulbs and sounds to receive certain sound and light interventions. For example, the lights will brighten during the users expected circadian dip.",[19],"Behavioral: SleepEZ CBTi",{"label":21,"type":16,"description":22,"interventionNames":23},"Sleep Hygiene + IoT","Participants randomized to this study arm will experience sleep hygiene education and training, a component of CBT-I, which will also occur within the SleepSpace software to ensure all participants receive the same software platform and adherence is tracked uniformly across solutions. Users will have access to a version of our electronic application that enables them to track sleep in a sleep diary, access the animated Sleep Hygiene content created in the same way as the videos in the CBTi-IoT-AI condition, and integrate with smart light bulbs and sounds to receive certain sound and light interventions.",[24],"Behavioral: Sleep Hygiene IoT",[26,31,35],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"BEHAVIORAL","What distinguishes this condition is increased customization of the CBT-I content and increased usage of the Internet of Things (IoT) devices used to promote CBT-I directives.",[9],null,{"type":27,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"SleepEZ CBTi","This condition includes interactive videos about CBT-I and leverages some IoT interventions.",[15],{"type":27,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"Sleep Hygiene IoT","This intervention includes intractive videos regarding sleep hygiene, a component of CBT-I and leverages some IoT interventions.",[21],[40],{"name":41,"affiliation":42,"role":43},"Daniel Taylor, PhD","University of Arizona","STUDY_DIRECTOR",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":30,"email":49},"Daniel Gartenberg, PhD","CONTACT","732-668-1250","dan@sleepspace.com",{"name":51,"role":47,"phone":52,"phoneExt":30,"email":53},"Melissa Markovitz","9177571660","mel@sleepspace.com",[55],{"facility":56,"status":30,"city":57,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"SleepSpace","New York","10012","United States","US",{"type":62,"coordinates":63},"Point",[64,65],-74.00597,40.71427,{"lat":65,"lon":64},[68],{"name":46,"role":47,"phone":69,"phoneExt":30,"email":49},"7326681250",{"type":71,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"PRINCIPAL_INVESTIGATOR","Daniel Gartenberg","CEO",[75],{"name":76,"class":77},"National Institute on Aging (NIA)","NIH","100617248","phase-2-deep-sleep-in-older-adults-100617248",false,"NCT07316153","Deep Sleep in Older Adults","An Internet of Things Automated Cognitive Behavioral Therapy for Insomnia That Improves Cognition in Older Adults","Inclusion Criteria\n\n1. Fluent English speaker and reader.\n2. Capable of providing one's own informed consent.\n\n   1. As determined by validated, abbreviated phone-based remote Montreal Cognitive Assessment (MoCA) testing score of ≥18, which is the score that separates Mild Cognitive Impairment (MCI) from Alzheimer's Disease and Related Dementia (ADRD).\n3. Age 65+ years old (inclusive) at enrollment, but if recruitment is slow, the investigators may adjust the criteria to 60+, and if it is still slow, it could go as low as 55+ years old.\n\n   1. As self-reported on screening survey and later verified in video appointment (e.g. Zoom Health)\n4. If residing in a community residence (such as a retirement community) in which a Medical Director designates living status categories, then the participant must be Independent Living status (or equivalent).\n\n   a. As self-reported on screening survey\n5. Insomnia Severity Index score ≥15 (i.e., at least \"clinical insomnia,\" that is \"moderate-to-severe\") - but if recruitment is slow then the investigators will recruit with ISI score ≥11 \"mild-to-severe\").\n\n   a. As self-reported on the ISI screening survey\n6. Willing to refrain from initiating new therapeutic interventions (e.g. medication; behavioral) that are not a part of this study protocol for issues pertaining to sleep for the duration of study participation.\n\n   1. By self-report\n7. Willing to maintain any existing physician-directed pharmacologic intervention for issues pertaining to sleep for the duration of study participation.\n\n   a. By self-report\n8. Has a residence with WIFI.\n\n   a. By self-report\n9. Normal hearing with or without a hearing aid.\n\n   a. By self-report\n10. Difficulty falling asleep, staying asleep, or waking too early, occurring at least 3 nights\u002Fweek for 3+months, causing significant daytime distress\u002Fimpairment (e.g., fatigue, poor focus, mood issues), despite adequate sleep opportunity, and not better explained by another sleep disorder or substance.\n\n    1. By Sleep Condition Indicator \\[SCI\\]\n\nExclusion Criteria\n\n1. Illicit drug use in the past month (except for marijuana because it is legal in many States, and the investigators are recruiting nationwide).\n\n   a. As self-reported on screening survey. Marijuana usage will be tracked via self-report and examined as a moderator.\n2. Diagnosed serious mental health disorder.\n\n   1. Specifically, psychosis or bipolar depression, severe major depression, moderate to high risk of suicide, dementia\n   2. As self-reported on screening survey\n3. Currently or recent engaged (past 1-year) in evidence-based psychotherapy for Insomnia (e.g., CBTi), in addition to ever receiving a full course of CBTi:\n\n   a. By self-report\n4. Cohabitating with a current or previous participant in this study.\n\n   a. This criterion is to avoid cross-contamination of study condition awareness, if two cohabitating individuals are randomized into different study arms.\n5. Initiation of any psychological treatment in the last 3-months.\n6. A highly irregular schedule (e.g. shift work) that would prevent adoption of intervention strategies, as evaluated through the Shift Work Disorder Index.\n7. Previous exposure to the SleepSpace software.\n8. Medical conditions that are exacerbated by sleep restriction.\n9. Planned major surgery during the trial.","ALL","65 Years",{"count":88,"type":89},180,"ESTIMATED","INTERVENTIONAL",[92],"PHASE2","This double blind randomized clinical trial on older independent-living healthy individuals with symptoms of insomnia will harness Cognitive Behavioral Therapy for Insomnia (CBT-I) and augment it with ambulatory data collection devices, personalized digital content, and smart sound and light cues (CBT-I +Internet of Things \\[IoT\\]+Artificial Intelligence \\[AI\\]). With this approach, the investigators aim to overcome many of the limitations that CBT-I in the clinic faces: the investigators can implement it in ambulatory settings while providing increased (remote) accessibility to therapy. The investigators will compare the CBT-I +IoT+AI to active controls that also integrate with smart phone devices, including SleepEZ, which is also based on CBT-I, and sleep hygiene education. These active controls will help determine whether CBT-I +IoT+AI is effective at treating insomnia based on the Insomnia Severity Index (ISI) (primary outcome), sleep metrics (secondary outcome), cognitive performance (secondary outcome), and additional outcomes like therapeutic adherence and other mental health assessments. Participants will be asked to track sleep with wearable and nearable devices, complete surveys, and complete cognitive assessments.",[95,96],"Insomnia","Insomnia Chronic",[98,99,100,101,102,103,104],"cognitive behavioral therapy","internet of things","wearables","insomnia","older adults","cognitive impairment","cognition","NOT_YET_RECRUITING","2025-12-31",{"date":108,"type":109},"2026-01-05","ACTUAL",{"date":111,"type":89},"2026-03-01",{"date":113,"type":89},"2026-12-30",{"name":5,"class":6},1]