[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100546816":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":35,"locations":42,"responsibleParty":64,"collaborators":66,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":40,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":44,"whyStopped":40,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Uniformed Services University of the Health Sciences","FED",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Nightmare Deconstruction and Reprocessing","EXPERIMENTAL","Psychotherapy that uses exposure to nightmare images for trauma activation with the goal of memory reconsolidation.",[13],"Behavioral: Nightmare Deconstruction and Reprocessing",{"label":15,"type":10,"description":16,"interventionNames":17},"NightWare","Wristband device that detects physiologic signals during sleep that indicate a possible nightmare and gently vibrates to rouse the sleeper without fully waking them.",[18],"Device: NightWare",[20,26],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"BEHAVIORAL","A psychotherapy that uses exposure to nightmare images for trauma activation in order to facilitate trauma memory reconsolidation",[9],[25],"NDR",{"type":27,"name":15,"description":16,"armGroupLabels":28,"otherNames":29},"DEVICE",[15],[30],"NW",[32],{"name":33,"affiliation":5,"role":34},"James C West, MD","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":40,"email":41},"Patricia Spangler, PhD","CONTACT","240-620-4076",null,"patricia.spangler.ctr@usuhs.edu",[43],{"facility":5,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"RECRUITING","Bethesda","Maryland","20814","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-77.10026,38.98067,{"lat":54,"lon":53},[57,60,61,62],{"name":33,"role":38,"phone":58,"phoneExt":40,"email":59},"301-319-4281","james.west@usuhs.edu",{"name":37,"role":38,"phone":39,"phoneExt":40,"email":41},{"name":33,"role":34,"phone":40,"phoneExt":40,"email":40},{"name":37,"role":63,"phone":40,"phoneExt":40,"email":40},"SUB_INVESTIGATOR",{"type":65,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR",[67],{"name":15,"class":68},"INDUSTRY","100546816","phase-2-nightmare-deconstruction-and-reprocessing-vs-nightware-wristband-100546816",false,"NCT06399874","Nightmare Deconstruction and Reprocessing vs. NightWare Wristband","Pilot Trial Comparing Exposure and Nonexposure Treatments for Posttrauma Nightmares and Insomnia: Nightmare Deconstruction and Reprocessing vs. NightWare Wristband","NDR\u002FNW","Inclusion Criteria:\n\n* Active duty service members and veterans\n* Minimum symptom severity:\n* Has had at least 1 nightmare per week for the past month\n* Has a minimum ISI score of 8\n* If taking medications for PTSD, depression, anxiety, or insomnia, must be on stable dose for 8 weeks.\n\nExclusion Criteria:\n\n* Serious risk of suicide\n* Psychosis, bipolar disorder, or alcohol or substance use disorder\n* Untreated moderate to severe sleep apnea\n* Use of synthetic glucocorticoid beta blockers, prazosin, or varenicline\n* Current evidence-based or experimental psychotherapy directly targeting nightmares, insomnia, or PTSD\n* Inability to recall nightmare content\n* Inability to wear wristband or sync wristband data\n* Inability to comply with blood draws\n* Refusal to consent to DNA analysis of blood samples\n* Refusal to consent to audio recording of study visits\n* REM sleep behavior disorder or narcolepsy as determined by investigator","ALL","22 Years","64 Years",{"count":81,"type":82},30,"ESTIMATED","INTERVENTIONAL",[85],"PHASE2","The overall goal of this Phase IIa randomized controlled pilot trial is to assess the potential efficacy of two emerging treatments for post-trauma nightmares and to test the feasibility of study design and methods. Symptom change will be assessed in two treatment arms: (1) Nightmare Deconstruction and Reprocessing (NDR), an exposure-based psychotherapy; and (2) NightWare (NW), a non-exposure approach using a wristband device. The investigators will also assess the feasibility of circadian-dependent blood sampling and use of another wristband to collect physiologic data. Specific aims are: (1) Compare evidence of how well participants tolerate and comply with the two treatments and test feasibility of methods and procedures; (2) Collect additional evidence of the potential efficacy of two contrasting non-pharmacologic approaches to treating posttraumatic nightmares; (3) Explore the operational stress index (OSI) as a reliable, objective measure of sleep disturbance and nightmare events.",[88],"Nightmare",[90,91,92,93,94,95,96,97,98],"Nightmares","Insomnia","PTSD","Heart Rate Variability","Electrodermal Activity","BDNF","Cortisol","ACTH","Treatment","2025-03-25",{"date":101,"type":102},"2025-03-30","ACTUAL",{"date":104,"type":102},"2024-06-11",{"date":106,"type":82},"2026-03",{"name":5,"class":6},1]