[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nightmare\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nightmare":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,55,83,108,144,184,211],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":35,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100615129","insight-insomnia-nightmares-and-sympathetic-hyperactivity-intervention-100615129",false,"NCT07288593","INSIGHT: Insomnia, Nightmares, and Sympathetic Hyperactivity Intervention","Insomnia, Nightmares, and Sympathetic Hyperactivity Intervention in the warfiGHTer (INSIGHT)","INSIGHT","Inclusion Criteria:\n\n* Defense Enrollment Eligibility Reporting System (DEERS) Eligible\n* Current or former military service member\n* Able to read and understand English language without the use of an interpreter\n* Habitual bedtime between 9:00 PM and 1:00 AM\n* Aged 18-62 (inclusive)\n* Able to commit to study procedures\n\nExclusion Criteria:\n\n* Use of alpha or beta-receptor active medications or prescribed sleep aids in the last 3 months\n* Started use of SNRIs or SSRIs in the last 3 months\n* Pregnant\n* Receiving ongoing and extensive treatment for a new or acute psychiatric disorder within 90 days, other than routine follow-up and care\n* Starting concurrent evidence based psychiatric treatment within the past three months\n* Diagnosis of a serious medical condition (i.e., late-stage cancer or heart disease)\n* Routine night shift work in the past 3 months\n* Unstable neurological disease\u002Fautonomic disorders\u002F heart conditions\u002Fpsych\u002F sleep or other unstable disorder as determined by the Principal Investigator\u002FAssociate\n* Investigators determined by clinical interview by Mini international neuropsychiatric interview and medical health questionnaire\n* Excessive alcohol use as determined by the AUDIT-C (AUDIT-C \\> 3)\n* Started using any other medication (prescribed or over-the-counter) for the purpose of improving sleep in the last 90 days (e.g., barbiturates, benzodiazepines, melatonin, natural supplements and herbs, antidepressants, antihistamines, etc.)\n* Receiving treatment for substance use disorder within 90 days from the start of the study\n* Evidence of moderate or severe Obstructive Sleep Apnea (OSA): Determined by the STOP-BANG questionnaire: STOP-BANG greater than 5 Determined by EMR PSG records: moderate or severe OSA \\[apnea-hypopnea index (AHI)≥15\\]\n* Clinically significant suicidality as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)\n* Currently participating in other research studies for improving sleep\n* Currently participating in other research studies for improving PTSD\n* Currently in therapy for the primary purpose of improving sleep (e.g., CBT-I)\n* Currently undergoing other treatment to improve sleep (e.g., acupuncture)\n* History or diagnosis of any of the following sleep disorders: narcolepsy, shift-work disorder or circadian rhythm disorders\n* Prone to problems with venipuncture including fainting, hematoma, and infection\n* Moderate and high nicotine dependence based on the Fagerstrom Test for Nicotine Dependence (\\> 4 on the Fagerstrom Test for Nicotine Dependence) High caffeine dependence based on the Caffeine Dependence Questionnaire (\\> 30 on the Caffeine Dependence Questionnaire)\n* Currently experiencing a neurological disorder (e.g., stroke, Parkinson's, MS, etc.)\n* Exclusion for optional MRI visit:\n\nMetal in body that is ferromagnetic \u002F incompatible with MRI or other safety issues and indicated by screen Previous adverse reactions to sleep deprivation Illicit drug use as determined by participant self-report Alcohol in system at time of MRI overnight as determined participant self report Nicotine use in the last 3 months\n\nFor poor sleep group:\n\nTBI History of epilepsy or suspected seizure disorder.",true,"ALL","18 Years","62 Years",{"count":22,"type":23},180,"ESTIMATED","INTERVENTIONAL",[26],"NA","The INSIGHT study is a multi-site clinical research program designed to examine how insomnia and symptoms of sympathetic hyperactivity impair sleep, cognition, and physiological restoration in warfighters, and to evaluate whether a wearable therapeutic device can improve these outcomes. Warfighters with a history of traumatic brain injury, post-traumatic stress disorder, or chronic operational stress commonly report disrupted sleep accompanied by manifestations of nocturnal sympathetic activation such as diaphoresis, palpitations, hyperarousal, and nightmares. These symptoms erode sleep quality, reduce cognitive performance, and undermine psychological resilience and operational readiness. Insomnia is two to three times more common in military populations than in civilians, and both TBI and PTSD independently elevate the risk for dysregulated autonomic tone. Excessive sympathetic activity during REM sleep disrupts the normally quiescent locus coeruleus state required for adaptive emotional processing and may contribute to the genesis of nightmares. Excessive sympathetic tone may also interfere with deep NREM-dependent glymphatic clearance, a recently discovered mechanism that supports cognitive restoration and metabolic waste removal. Yet, no study has comprehensively linked these physiological processes in warfighters or evaluated whether wearable-derived autonomic measures can meaningfully stratify insomnia phenotypes. The INSIGHT protocol addresses this gap through a two-phase design integrating multimodal biomarker collection, wearable technology validation, advanced imaging, and a randomized controlled intervention. Phase 1 enrolls 250 participants (50 healthy controls and 200 poor sleepers with or without PTSD and TBI) who undergo structured screening, cognitive testing, and detailed baseline assessments before completing a 2-week at-home data collection period. During this period, participants wear a suite of devices, including EEG headbands, ECG patches, PPG-based sensors, accelerometry rings, blood pressure devices, temperature sensors, and smartwatches, to capture autonomic activity, sleep architecture, cardiovascular and respiratory variability, movement, sudomotor activity, and circadian body temperature patterns. Ecological momentary assessments administered three times daily track fluctuations in sleep quality, mood, PTSD symptoms, and daytime functioning, while urine samples collected on the final three days allow for biochemical analysis of hormonal and sympathetic biomarkers. After the at-home period, all participants complete an overnight in-lab polysomnogram combined with fNIRS to measure sleep stages, autonomic dynamics, cerebral hemodynamics, and glymphatic signatures. A subset of participants also completes an optional overnight MRI with simultaneous EEG following controlled sleep deprivation, enabling state-of-the-art imaging of human glymphatic activity using the MAGNUS MRI platform. This optional visit provides unprecedented insight into how TBI, PTSD, and insomnia alter the physiology of sleep-dependent brain fluid dynamics. In Phase 2, all poor sleepers enter a double-blind, sham-controlled, 30-day randomized trial testing the therapeutic potential of the NightWare smartwatch. NightWare detects sympathetic surges during sleep through heart rate elevations and movement patterns and delivers brief haptic vibrations aimed at interrupting escalating autonomic arousal. Although originally cleared for nightmare treatment, its mechanism is well suited for SNH-related insomnia more broadly. Participants use the device daily while continuing EMA surveys, wearable monitoring, and cognitive assessments, generating rich physiological and behavioral data throughout the intervention. The primary goal is to determine whether reducing nocturnal sympathetic spikes leads to measurable improvements in sleep quality, autonomic stability, daytime functioning, and symptom burden. In parallel, Phase 2 data enable development of the Multi-Organ Autonomic Index of Sleep, an integrated biomarker model that combines neurological, cardiovascular, respiratory, and dermal signals to predict treatment response and classify insomnia subtypes.\n\nThe INSIGHT study will produce the most comprehensive dataset to date linking autonomic physiology, glymphatic function, sleep architecture, wearable-derived biomarkers, cognition, and clinical outcomes in warfighters. By identifying physiological signatures of sympathetic hyperarousal and determining whether a non-pharmacological wearable intervention can meaningfully improve sleep, INSIGHT directly supports Department of Defense priorities to enhance readiness, resilience, and long-term neurological health in service members. Wearable tools capable of monitoring and improving sleep outside the laboratory have the potential to transform both clinical care and operational performance, offering scalable and accessible approaches to restoring sleep and optimizing recovery.",[29,30,31,32,33,34],"Nightmare","Insomnia","PTSD","TBI","Sleep Disorder (Disorder)","REM Behavior Disorder",[36,37,38,39,40,30,31,41],"Nightmares","Wearables","Intervention","Sleep quality","Hyperarousal","Healthy Participants","NOT_YET_RECRUITING","2026-04-27",{"date":45,"type":46},"2026-04-28","ACTUAL",{"date":48,"type":23},"2026-06-01",{"date":50,"type":23},"2027-12",{"name":52,"class":53},"Uniformed Services University of the Health Sciences","FED",2,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":24,"phases":63,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100550038","behavioral-treatment-for-nightmares-in-rem-sleep-behavior-disorder-100550038","NCT06441864","Behavioral Treatment for Nightmares in REM Sleep Behavior Disorder","Inclusion Criteria:\n\n* Diagnosis of isolated RBD or RBD secondary to neurodegenerative disease\n* Age 18 or older\n* Speak, read, and write English\n* Live in the United States\n* Nightmare frequency ≥3 times per week\n* Disturbing Dream and Nightmare Severity Index score indicative of nightmare disorder\n* Sleep, neurological, and psychiatric medications stable for at least 1 month and willing to keep medications stable through the course of the study\n* Live with a family member who is willing to participate in the study\n\nExclusion Criteria:\n\n* Possible dementia\n* Narcolepsy\n* Posttraumatic stress disorder\n* Previous behavioral treatment for nightmares\n* Currently engaged in sleep- or trauma-focused psychotherapy\n* Taking a medication that could cause RBD, if the medication was started prior to onset of RBD symptoms\n\nInclusion Criteria (Family Members):\n\n* Live with a family member who meets all of the above criteria\n* Age 18 or older\n* Speak, read, and write English\n* Live in the United States",{"count":62,"type":23},20,[26],"The purpose of this clinical trial is learn whether a behavioral (non-medication) treatment can reduce nightmares in adults with Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD). People with RBD will be enrolled in the study along with their family members (a partner or other family member residing in the same home). All participants will receive the treatment via videoconference and will complete 2 assessments. Participants with RBD will attend 7 sessions, and their family members will attend 2 of those sessions with them.",[29,66,67],"Nightmare Disorder With Associated Other Sleep Disorder","REM Sleep Behavior Disorder",[69,70],"Imagery Rehearsal Therapy","Cognitive Behavioral Therapy for Nightmares","RECRUITING","2026-03-09",{"date":74,"type":46},"2026-03-12",{"date":76,"type":46},"2024-07-15",{"date":78,"type":23},"2026-12-01",{"name":80,"class":81},"University of Utah","OTHER",1,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":24,"phases":93,"briefSummary":94,"conditions":95,"keywords":100,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":82},"100545584","decreasing-nightmares-in-adults-with-narcolepsy-100545584","NCT06383806","Decreasing Nightmares in Adults With Narcolepsy","Imagery Rehearsal Therapy for the Treatment of Nightmares in Narcolepsy: A Pilot Randomized Controlled Trial","DAWN","PARTICIPANTS WITH NARCOLEPSY\u002FNIGHTMARES\n\nInclusion Criteria:\n\n* Diagnosis of narcolepsy type 1 or narcolepsy type 2\n* Nightmare frequency of ≥1 times per week\n* Age 18 or older\n* Able to speak, read, and write in English\n* Live in the United States\n* Sleep and psychiatric medications stable for ≥ 1 month and willing to keep medications stable for the duration of the study\n\nExclusion Criteria:\n\n* Currently engaged in trauma- or sleep-related psychotherapy\n* Previous behavioral treatment for nightmares\n* Medical, psychiatric, or cognitive condition which would interfere with ability to engage in the treatment\n* Untreated moderate-severe sleep apnea\n\nPARTICIPANTS WHO ARE PARTNERS OF SOMEONE WITH NARCOLEPSY\n\nInclusion Criteria:\n\n* Live with a romantic partner who meets the above criteria and has agreed to participate in the study\n* Age 18 or older\n* Able to speak, read, and write in English\n* Live in the United States",{"count":92,"type":23},80,[26],"The purpose of this clinical trial is learn whether a behavioral (non-medication) treatment can reduce nightmares in adults with narcolepsy. All participants will receive the treatment and will complete three assessments. Half of the participants will receive the treatment after the first assessment, and half will receive it after the second assessment. Romantic partners of participants with narcolepsy will also be eligible to enroll in the study. Partners will complete three assessments but will not participate in the treatment.",[96,97,98,99,29,66],"Narcolepsy","Narcolepsy Type 1","Narcolepsy With Cataplexy","Narcolepsy Without Cataplexy",[69,70],{"date":102,"type":46},"2026-03-10",{"date":104,"type":23},"2026-04-01",{"date":106,"type":23},"2027-09",{"name":80,"class":81},{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":24,"phases":117,"briefSummary":118,"conditions":119,"keywords":133,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":142,"locationsCount":54},"100471118","art-therapy-and-emotional-well-being-in-military-populations-with-posttraumatic-stress-symptoms-100471118","NCT05414708","Art Therapy and Emotional Well Being in Military Populations With Posttraumatic Stress Symptoms","Inclusion Criteria:\n\n* DEERS Eligible\n* Active Duty or Veteran separated within the past 10 years\n* Significant posttraumatic stress symptoms (score of \\>\u002F=31 on the PCL-5)\n\nExclusion Criteria:\n\n* History of moderate, severe, or penetrating brain injury\n* History of psychotic disorder, bipolar disorder, or active suicidal or homicidal ideation\n* History of multiple sclerosis, Huntington's disease, or Alzheimer's disease\n* History of stroke or myocardial infarction\n* History of brain tumor\n* History of seizures\n* Contradictions for MRI (for example, participants will be excluded for pregnancy, metal implants or suspected shrapnel, aneurysm\u002Fintracranial clips, cardiac pacemakers or implanted programmable devices or pumps)\n* Unable to provide informed consent\n* History of previous exposure to art therapy\n* Active substance use disorder","64 Years",{"count":116,"type":23},40,[26],"Art therapy is used across the Military Health System for treatment of posttraumatic symptoms, but there is limited research on how art therapy is able to restore emotional expression and regulation in service members. This research hopes to learn about the effects of art therapy on emotional expression and regulation in service members as well as the neurological systems at work. If a participant chooses to be in this study, he or she will attend eleven sessions over a period of six to eight months. The first session will be an interview and self-assessment questionnaires to collect information on a variety of symptoms, experiences, and personality traits, and an MRI scan. During the MRI scan, participants will be asked to perform a task where they will be shown a series of neutral and negative images. The following eight sessions will be one-hour art therapy sessions with a certified art therapist. The tenth session will consist of the same self-assessment questionnaires and another MRI scan. The final session will consist of some of the same questionnaires from the tenth visit, as well as a qualitative interview done virtually three months after the tenth visit.",[31,120,121,122,123,124,29,125,126,127,128,129,130,131,132],"Military Activity","Post-Traumatic Headache","Posttraumatic Stress Disorder","Posttraumatic Stress Disorder, Delayed Onset","Sleep Disturbance","Irritable Mood","Anger","Combat and Operational Stress Reaction","Combat Stress Disorders","Military Family","Military Operations","Emotional Regulation","Emotion Processing",[31,134,135],"Military","Art Therapy","2026-01-06",{"date":138,"type":46},"2026-01-08",{"date":140,"type":46},"2022-02-01",{"date":50,"type":23},{"name":143,"class":53},"Walter Reed National Military Medical Center",{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":17,"sex":18,"minAge":151,"maxAge":152,"enrollmentInfo":153,"targetDuration":4,"studyType":24,"phases":155,"briefSummary":156,"conditions":157,"keywords":164,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":82},"100548358","nightware-and-cardiovascular-health-in-veterans-with-ptsd-100548358","NCT06419959","NightWare and Cardiovascular Health in Veterans With PTSD","Improving Cardiovascular Health in Veterans With PTSD by Treating Trauma-Related Nightmares With NightWare","Inclusion Criteria:\n\n1. Diagnosis of PTSD via American Psychiatric Association PTSD diagnostic criteria in the fifth edition of its Diagnostic and Statistical Manual of Mental Disorders (DSM-5).\n2. Self-report having repetitive nightmares contributing to disrupted sleep;\n3. Age 22 years (rationale is because the device has only been used in adults in 22 years and older);\n4. Resting blood pressure (BP, \\\u003C160\u002F100 mmHg);\n5. Fasted glucose \\\u003C126 mg\u002FdL;\n6. Poor overall sleep quality as indicated by a Pittsburgh Sleep Quality Index (PSQI) score 6 or higher;\n7. Epworth Sleepiness Scale (ESS): Question #8 score above \"0\" will prompt an additional question: Do you drive (\"get behind the wheel\") when you are drowsy? The answer must be \"No\" to be enrolled in the study due to safety concerns;\n8. Wireless Internet and two power outlets in sleeping location;\n9. Willingness not to use any other application which collects heart rate data on the phone and watch that is used for NightWare;\n\nExclusion Criteria:\n\n1. Unstable medical condition (e.g., uncontrolled hypertension or active CVD or cancer);\n2. Active infection (note, anyone with an active infection would become eligible once the infection has ended);\n3. Thyroid dysfunction, defined as an ultrasensitive TSH \\\u003C0.5 or \\>5.0 mU\u002FL; volunteers with abnormal TSH values will be re-considered for participation in the study after follow-up evaluation by the PCP with initiation or adjustment of thyroid hormone replacement; or other problems that would interfere with participation in the study;\n4. Use of insulin or sulfonylureas\n5. Pregnancy or currently breast feeding;\n6. Current history (past 3 months) of substance (excluding marijuana) or alcohol abuse per the SCID-5. Adults with past substance or alcohol use disorders will be allowed to participate;\n7. Participants will be excluded if they report elevated acute risk for suicidal self-directed violence warranting immediate hospitalization (e.g., suicidal ideation with intent, evaluated by the Columbia-Suicide Severity Rating Scale \\[C-SSRS\\]).\n8. Shift workers (due to circadian rhythm disruption);\n9. Diagnosis of active disorder of arousal from non-rapid eye movement sleep, rapid eye movement sleep behavior disorder, or narcolepsy;\n10. Nocturia that causes awakening from sleep;\n11. Known sleep walking or acting out dreams (contraindication to NW use);\n12. Diagnosis or suspicion of dementia;\n13. Seizure disorder\n14. Participants experiencing severe cognitive impairment or current psychiatric symptoms of such severity that would preclude participation (e.g., active psychosis, imminently suicidal)","22 Years","88 Years",{"count":154,"type":23},125,[26],"The purpose of this study is to learn more about the effectiveness of a prescription wrist-wearable device called NightWare (NW) on improving sleep in Veterans with nightmares related to posttraumatic stress disorder (PTSD). The investigators also want to learn whether it improves cardiovascular health among this population.",[158,159,160,161,29,162,163],"Post-traumatic Stress Disorder (PTSD)","Cardiovascular Diseases","Autonomic Dysfunction","Vascular Stiffness","Endothelial Dysfunction","Veteran",[165,166,167,168,163,169,170,171,172,173,159,174],"Sleep","Oxidative stress","aging, inflammation","sex\u002Fgender","Trauma and Stressor Related Disorders","Mental Disorders","Nervous System Diseases","Autonomic Nervous System Diseases","Primary Dysautonomias","Stress Disorders, Post-Traumatic","2025-09-11",{"date":177,"type":46},"2025-09-12",{"date":179,"type":46},"2025-09-10",{"date":181,"type":23},"2026-12-31",{"name":183,"class":53},"VA Office of Research and Development",{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":4,"eligibilityCriteria":190,"healthyVolunteers":17,"sex":191,"minAge":151,"maxAge":192,"enrollmentInfo":193,"targetDuration":4,"studyType":24,"phases":195,"briefSummary":196,"conditions":197,"keywords":201,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":54},"100594558","nightware-and-cardiovascular-health-in-women-with-ptsd-100594558","NCT07021014","NightWare and Cardiovascular Health in Women With PTSD","Improving Cardiovascular Health in Women With PTSD by Treating Trauma-Related Nightmares With NightWare","Inclusion Criteria:\n\n* Healthy, as determined by medical history\n* Group Specific Eligibility\n* PTSD Group\n* Lifetime PTSD: screened using Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) and confirmed via Clinician Administered PTSD Scale for DSM-5 (CAPS-5)\n* Prior trauma exposure: screened using Brief Trauma Questionnaire (BTQ)\n* Self-report having repetitive nightmares contributing to disrupted sleep\n* Poor overall sleep quality: PSQI score 6 or higher\n* Control Group\n* No lifetime PTSD: screened using PC-PTSD-5\n* No prior trauma exposure: screened using BTQ\n* Do not self-report having repetitive nightmares contributing to disturbed sleep\n\nExclusion Criteria:\n\n* Pre-existing (e.g., diabetes, liver, kidney disease) or unstable medical condition (e.g., uncontrolled hypertension or active CVD or cancer) or systemic illness that would interfere with interpretation of the study outcomes\n* Body Mass Index ≥ 40 kg\u002Fm2\n* Use of medications that might influence cardiovascular or renal function (i.e., antihypertensive, lipid lowering medications, GLP-1\u002FGIP RAs)\n* Active infection (note, anyone with an active infection would become eligible once the infection has ended)\n* Abnormal thyroid, liver, or kidney function testing during the screening examination or bloodwork. Abnormal kidney function defined as creatinine \\>1.3mg\u002FdL. Abnormal liver function tests within 1.5x ULN. UCH Clinical Lab ULN for AST and ALT are 39 and 52, respectively. Women with TSH levels outside of the normal range (0.5-5.0 mLU\u002FL) will be referred to their PCP and will be allowed study entry once their TSH levels are normalized \\> 3 months\n* Plasma glucose \\>126 mg\u002Fdl under fasting conditions\n* Use of insulin or sulfonylureas\n* Pregnant, within 12 months postpartum or currently breast feeding\n* Current history of substance (excluding marijuana) or alcohol abuse per the SCID-5. Adults with past substance or alcohol use disorders will be allowed to participate.\n* Report elevated acute risk for suicidal self-directed violence warranting immediate hospitalization (e.g., suicidal ideation with intent, evaluated by the C-SSRS).\n* Shift workers\n* Diagnosis of active disorder of arousal from non-rapid eye movement sleep, rapid eye movement sleep behavior disorder, or narcolepsy\n* Nocturia that causes awakening from sleep\n* Epworth Sleepiness Scale: Question #8 score above \"0\" will prompt an additional question: Do you drive (\"get behind the wheel\") when you are drowsy? The answer must be \"No\" to be enrolled in the study due to safety concerns\n* Known sleep walking or acting out dreams (contraindication to NightWare use)\n* Diagnosis or suspicion of dementia\n* Participants experiencing severe cognitive impairment or current psychiatric symptoms of such severity that would preclude participation (e.g., active psychosis, imminently suicidal)\n* Current use of vitamin\u002Fsupplements (including melatonin) or anti-inflammatory medications, participants will be included if they are willing to stop taking vitamin\u002Fsupplements or anti-inflammatory medications 2 weeks prior to the first vascular visit.\n* Current or planned participation in an interventional study during the present study\n* Participants must have access to wireless internet and two power outlets where they sleep","FEMALE","40 Years",{"count":194,"type":23},36,[26],"The purpose of this study is to determine whether NightWare therapeutic intervention improves biomarkers of vascular and renal function in premenopausal women with PTSD-related nightmares, and examine whether these improvements restore them to levels observed in age-matched women without PTSD.",[198,159,160,161,29,162,199,200,169],"Post Traumatic Stress Disorder","Kidney Diseases","Renal Dysfunction",[165,169,198,159,199,200,160],"2025-06-05",{"date":204,"type":46},"2025-06-13",{"date":206,"type":23},"2025-07",{"date":208,"type":23},"2028-07",{"name":210,"class":81},"University of Colorado, Denver",{"id":212,"slug":213,"hasResults":11,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":217,"eligibilityCriteria":218,"healthyVolunteers":11,"sex":18,"minAge":151,"maxAge":114,"enrollmentInfo":219,"targetDuration":4,"studyType":24,"phases":221,"briefSummary":223,"conditions":224,"keywords":225,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":82},"100546816","phase-2-nightmare-deconstruction-and-reprocessing-vs-nightware-wristband-100546816","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",{"count":220,"type":23},30,[222],"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.",[29],[36,30,31,226,227,228,229,230,231],"Heart Rate Variability","Electrodermal Activity","BDNF","Cortisol","ACTH","Treatment","2025-03-25",{"date":234,"type":46},"2025-03-30",{"date":236,"type":46},"2024-06-11",{"date":238,"type":23},"2026-03",{"name":52,"class":53}]