[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560476":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":39,"studyPopulation":26,"armGroups":40,"interventions":56,"overallOfficials":62,"centralContacts":66,"locations":75,"responsibleParty":93,"collaborators":96,"id":102,"slug":103,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":104,"sex":110,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":26,"studyType":116,"phases":117,"briefSummary":119,"conditions":120,"keywords":123,"overallStatus":77,"whyStopped":26,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"Stanford University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)","The CAPS-5 is a structured interview that is considered the gold standard for assessing post-traumatic stress disorder (PTSD). The CAPS-5 is designed to assess the 20 symptoms of PTSD as defined by the DSM-5, as well as the impact of these symptoms on social and occupational functioning. The CAPS-5 includes 20 items corresponding to the DSM-5 criteria for PTSD. Each item is rated for both frequency and intensity, with a 5-point scale (0-4) for each dimension. The total score ranges from 0 to 80, with higher scores indicating more severe symptoms. A score of \\>20 points indicates clinically significant PTSD symptoms. Superiority of \"Dream Experiences Group\" over \"Non-Dream Experiences Group\" will be demonstrated by a statistically significant greater decrease in the CAPS-5 when comparing pre-anesthesia scores to post-anesthesia scores.","1 month post-intervention",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"Proportion of Participants With Clinical Response","Clinical response is defined as a reduction of ≥15 points (or ≥30% - 50%) in the CAPS-5 total severity score from baseline (pre-anesthesia) to Day +30 post-anesthesia, comparing the Dream versus No-Dream groups.",{"measure":18,"description":19,"timeFrame":12},"Proportion of Participants With Remission","Remission is defined as obtaining a score of ≤20 points on the CAPS-5, comparing the Dream versus No-Dream groups.",{"measure":21,"description":22,"timeFrame":12},"Change in the PTSD Checklist for DSM-5 (PCL-5)","The PCL-5 is a self-report measure designed to assess the 20 symptoms of post-traumatic stress disorder (PTSD) as defined by the DSM-5. Includes 20 items that correspond directly to the DSM-5 criteria for PTSD. Each item is rated on a 5-point Likert scale from 0 (Not at all) to 4 (Extremely), indicating how much the symptom has bothered the individual in the past week\u002Fmonth. The total score can range from 0 to 80, with higher scores indicating more severe PTSD symptoms. A score of 31-33 or higher is considered indicative of symptomatic PTSD. A reduction in PTSD symptoms will be indicated by a change in the PCL-5 total score from baseline (pre-anesthesia) to post-anesthesia, comparing the Dream versus No-Dream groups.",{"measure":24,"description":25,"timeFrame":12},"Treatment Response Assessed Using the PTSD Checklist for DSM-5 (PCL-5)","Proportion of participants achieving a reduction of ≥30% in the PCL-5 total score from baseline to Day +30, comparing the Dream versus No-Dream groups.",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":30,"primaryPurpose":31,"observationalModel":26,"timePerspective":26,"maskingInfo":32},"RANDOMIZED","PARALLEL","Two groups of participants will be randomized to either (a) Dream experiences group, or (b) Non-Dream experiences group.","TREATMENT",{"masking":33,"maskingDescription":34,"whoMasked":35},"TRIPLE","Double-blind, randomized, active-comparator (dose-controlled) participant-and assessor-blinded Phase 2 clinical trial (RCT)",[36,37,38],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR","GENERAL BACKGROUND\n\nPost-traumatic stress disorder (PTSD) affects millions of Americans, and it can make everyday life very challenging. PTSD is characterized by recurrent distressing memories and nightmares, flashbacks, hyperarousal, and avoidance of things that remind individuals of their traumatic event. Nightmares reflect impaired emotion regulation occurring during sleep. There is evidence that therapeutic applications of dreaming may help target nightmares and other PTSD symptoms because dreaming is involved in memory (re)processing and emotion regulation. There is preliminary evidence that dreaming during anesthesia may reduce symptoms of PTSD. However, larger studies are needed to systematically test this.\n\nAIM AND HYPOTHESES\n\nThe aim of this study is to test the efficacy of anesthesia-induced dreaming for PTSD in a (1) open-label trial (Phase I) and (2) a single-center double-blind, randomized, active-comparator (dose-controlled) participant-and assessor-blinded clinical trial (Phase II) in a non-surgical setting. The investigators predict that inducing and sustaining a dream state prior to emergence from anesthesia will result in reduced symptoms of PTSD.\n\nSTUDY DESIGN\n\nDesign:\n\nPhase I : Open-label study Phase II: Double-blind, randomized, active-comparator (dose-controlled) participant-and assessor-blinded Phase 2 clinical trial (RCT)\n\nSample Size:\n\nPhase I: N = 15 Phase II: N = 42 (21 in Dream Condition, 21 in Non-Dream Condition)\n\nVariables:\n\nPhase I and II: Outcome variables include: (1) Clinician-Administered PTSD Scale for DSM-5 (CAPS-5); (2) PTSD Checklist for DSM-5 (PCL-5)\n\nSTUDY PROCEDURES AND MEASURES\n\nThis research study is expected to take approximately four months to complete (per participant). During this time, participants will make two pre-screening visits via Zoom as well as one screening visit via Zoom and one in-person screening visit at Stanford Hospital. Participants will also complete daily assessments of sleep quality and dream experiences 2 weeks before and 2-4 weeks after the anesthesia session. In Phase I, participants will also wear the Muse headband to measure sleep quantity and quality daily for 2 weeks before and 2 weeks after the intervention session. In Phase II, participants will wear a GGX EEG Patch to measure sleep quantity and quality for 2 weeks before and 4 weeks after the intervention session. Participants will fill in pre-anesthesia and post-anesthesia questionnaires measuring mental health and well-being and, complete follow-up measures 1 day, 1 week, 2 weeks, 1 month, and 3 months after the anesthesia session.\n\nDuring the anesthesia session, participants will undergo EEG-guided infusion of propofol.\n\nIn Phase I, all participants will undergo at least two sessions: (1) a sedation protocol intended to elicit dream reports (Dream Condition); and (ii) a sedation protocol designed to elicit non-dream experiential reports (Non-Dream Condition).\n\nIn Phase II, participants will be randomized into either the Dream or Non-Dream Group, undergoing either the protocol designed to elicit dream experiences or non-dream experiences, respectively.\n\nImmediately upon emerging from anesthesia, participants will be interviewed using the modified Brice questionnaire and their responses audio- and video-recorded.",[41,47,52],{"label":42,"type":43,"description":44,"interventionNames":45},"Dream Experiences Group","EXPERIMENTAL","This group (n=21) will undergo a sedation protocol intended to elicit dream experiences.",[46],"Drug: Propofol",{"label":48,"type":49,"description":50,"interventionNames":51},"Non-Dream Experiences Group","ACTIVE_COMPARATOR","This Group (n=21) will undergo a sedation protocol designed to elicit non-dream experiences.",[46],{"label":53,"type":43,"description":54,"interventionNames":55},"Open-label anesthesia protocol","All participants (n = 15) will undergo both an EEG-guided sedation protocol intended to elicit dream experiences and a sedation protocol intended to elicit non-dream experiences.",[46],[57],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":26},"DRUG","Propofol","Propofol will be administered intravenously under EEG guidance according to the study-specific sedation protocol. The propofol administration parameters will vary according to the assigned study condition, with protocols designed to elicit either dream experiences or non-dream experiences.",[42,48,53],[63],{"name":64,"affiliation":5,"role":65},"Boris D Heifets, MD, PhD","PRINCIPAL_INVESTIGATOR",[67,71],{"name":64,"role":68,"phone":69,"phoneExt":26,"email":70},"CONTACT","(669) 241 6118","anesthesiastudy@stanford.edu",{"name":72,"role":68,"phone":73,"phoneExt":26,"email":74},"Pilleriin Sikka, PhD","6506808801","sikka@stanford.edu",[76],{"facility":5,"status":77,"city":78,"state":79,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"RECRUITING","Stanford","California","94305","United States","US",{"type":84,"coordinates":85},"Point",[86,87],-122.16608,37.42411,{"lat":87,"lon":86},[90],{"name":64,"role":68,"phone":91,"phoneExt":26,"email":92},"917 620 4241","bheifets@stanford.edu",{"type":65,"investigatorFullName":94,"investigatorTitle":95,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Boris D. Heifets","Associate Professor of Anesthesiology, Perioperative and Pain Medicine",[97,99],{"name":98,"class":6},"Tiny Blue Dot Foundation",{"name":100,"class":101},"Advanced Research Projects Agency for Health (ARPA-H)","FED","100560476","phase-2-induction-of-dreaming-with-eeg-and-anesthesia-for-post-traumatic-stress-disorder-100560476",false,"NCT06577636","Induction of Dreaming With EEG and Anesthesia for Post-traumatic Stress Disorder","Efficacy of Anesthesia-induced Dreaming for Post-traumatic Stress Disorder: a Randomized Controlled Trial","IDEA_PTSD","Inclusion Criteria:\n\nA subject will be eligible for inclusion when all of the following criteria are met:\n\n1. Male or female, 18 to 70 years of age\n2. Able to read, understand, and provide written, dated informed consent prior to screening.\n3. Diagnosed with PTSD prior to screening, according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition. The diagnosis of PTSD will be made by a trained study staff member and supported by the Quick Structured Clinical Interview for DSM Disorders (QuickSCID-5).\n4. Meet the threshold of CAPS-5 score of \\>20 during screening.\n5. Concurrent psychotherapy will be allowed if the type (e.g., supportive, cognitive behavioral, insight-oriented, et al) and frequency (e.g., weekly or monthly) of the therapy has been stable for at least 4 weeks prior to screening and if the type and frequency of the therapy is expected to remain stable during the course of the subject's participation in the study.\n6. Concurrent antidepressant therapy (e.g. SSRI or SNRI) will be allowed if the therapy has been stable for at least 4 weeks prior to screening, and if it is expected to remain stable during the course of the subject's participation in the study.\n7. In sufficiently good health to proceed with a low-risk elective procedure, characterized using the American Society of Anesthesiologists (ASA) physical status classification system as Class I or II, or III. ASA Class III participants whose functional impairment is directly related to a psychiatric diagnosis (depression, anxiety or PTSD) will be included.\n8. If female, a status of non-childbearing potential or use of an acceptable form of birth control\n9. Body mass index between 17-35 kg\u002Fm2.\n\nExclusion Criteria:\n\nA potential participant will NOT be eligible for participation if any of the following criteria are met:\n\n1. Female of childbearing potential who is not willing to use one of the specified forms of birth control during the study.\n2. Female who is pregnant or breastfeeding.\n3. Female with a positive pregnancy test on the day of, and prior to, the anesthesia session.\n4. Total CAPS-5 score ≤20 at either the screening.\n5. Current diagnosis or a recent history (within 2 years) of a Substance Use Disorder (SUD; Abuse or Dependence, as defined by DSM-V) rated \"moderate\" or \"severe\" per criteria of the QuickSCID-5, or Alcohol Use Disorder rated \"moderate\" or \"severe\" per QuickSCID-5 criteria. The following categories of SUD will NOT be excluded: nicotine dependence; alcohol or substance use disorder rated \"mild\"; alcohol or substance use disorder of any severity in remission, either early (3-12 months) or sustained (\\>12 months) time frames.\n6. History of schizophrenia or schizoaffective disorders, or a psychotic disorder as defined by QuickSCID-5 interview.\n7. History of anorexia nervosa, bulimia nervosa, or eating disorder not otherwise specified, within five years of screening.\n8. Any DSM-5 Disorder, which at screening is clinically predominant to their PTSD or has been predominant to their PTSD at any time within six months prior to screening.\n9. In the judgment of the investigator, the subject is at significant risk for suicidal behavior during the course of his\u002Fher participation in the study.\n10. A neurological disorder\n11. A cardiovascular disorder\n12. A pulmonary\u002Frespiratory disorder\n13. Clinically significant liver disease\n14. Clinically significant kidney disease\n15. Symptomatic gastroesophageal reflux disease, hiatal hernia, or other gastrointestinal disorder placing patient at risk for aspiration or that would merit categorization of patient as ASA Class III or higher\n16. An endocrine disorder\n17. Any other abnormal laboratory result at the time of the screening exam that in the view of the investigator poses a risk for participation in the study.\n18. Has abnormality on the screening physical examination that might affect safety, study participation or confound interpretation of study results, including any condition that would merit categorization of patient as ASA Class III or higher.\n19. Has a positive urine drug screen on the day of the anesthesia session.\n20. If, in the view of the participant's current primary mental health care provider this study poses a risk for participation (if a participant has a current mental health care provider).\n21. Participation in any clinical trial with an investigational drug or device that conflicts with this trial, within the past month or concurrent to study participation.","ALL","18 Years","70 Years",{"count":114,"type":115},42,"ESTIMATED","INTERVENTIONAL",[118],"PHASE2","The goal of this study is to test whether anesthesia-induced experiences can help alleviate symptoms of PTSD in an (1) open-label trial (Phase I) and (2) single-center double-blind, randomized, active-comparator (dose-controlled) participant-and assessor-blinded Phase 2 clinical trial (Phase II) in a non-surgical setting. Participants will undergo EEG-guided propofol anesthesia during which they will be either (1) receiving a sedation protocol associated with dream experiences upon emergence (Dream Condition), and\u002For (2) a sedation protocol associated with non-dream experiences (Non-Dream Condition). The investigators will then investigate whether the Dream Condition is associated with a larger reduction in PTSD symptoms than the Non-Dream Condition.",[121,122],"PTSD","Post-traumatic Stress Disorder",[124,125,121,126,127,128],"anesthesia","propofol","post-traumatic stress disorder","dreaming","dreams","2026-09-29",{"date":131,"type":132},"2026-10-02","ACTUAL",{"date":134,"type":132},"2025-07-21",{"date":136,"type":115},"2029-05",{"name":5,"class":6},1]