[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Uniformed Services University of the Health Sciences\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":358},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,46,74,106,142,173,203,228,256,277,306,335],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100596804","evaluation-of-a-group-based-skills-training-for-increasing-mental-toughness-100596804",false,"NCT07050238","Evaluation of a Group-based, Skills Training for Increasing Mental Toughness","SAFEGUARD Life Force","Inclusion Criteria:\n\n* Active duty Soldiers in the regular Army\n* Age 18 or older\n* Stationed at Fort Hood, TX\n\nExclusion Criteria:\n\n* Soldiers with self-identified plans of leaving active duty service within 12 months of the baseline assessment\n* Soldiers having a planned permanent change in station (PCS) or deployment within 12 months of the baseline assessment",true,"ALL","18 Years",{"count":20,"type":21},2400,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of the Life Force study is to (1) evaluate the efficacy of targeted, skills-based training for enhancing mental toughness and mitigating harmful and high-risk behaviors in active-duty Soldiers, and (2) to determine who benefits the most from this type of training. Researchers will compare the training group to a control group. All participants will complete a baseline survey and two follow up surveys at 6 and 12 months post-baseline. The group assigned to the Life Force training condition will also complete a 5-session, group-based, skills training program.",[27,28],"Resilience","Mental Toughness",[28,30,31,32],"Active-duty Military","Risk Reduction","Prevention","RECRUITING","2026-06-11",{"date":36,"type":37},"2026-06-15","ACTUAL",{"date":39,"type":37},"2026-01-06",{"date":41,"type":21},"2029-07-01",{"name":43,"class":44},"Uniformed Services University of the Health Sciences","FED",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":45},"100624065","evaluation-of-a-telehealth-case-management-intervention-to-prevent-suicide-among-soldiers-discharged-from-psychiatric-hospitalization-100624065","NCT07404787","Evaluation of a Telehealth Case Management Intervention to Prevent Suicide Among Soldiers Discharged From Psychiatric Hospitalization","SAFEGUARD Phase 2 Pathfinding Study","Inclusion Criteria:\n\n* Active duty Regular Army soldiers recently discharged from inpatient psychiatric care at a military treatment facility in the US\n* Access to telephone and computer (including smartphone)\n\nExclusion Criteria:\n\n* Impaired ability to provide informed consent\n* Terminal illness\n* Failure to complete baseline survey within 30 days of discharge\n* Positive screen for post-discharge suicide-related behaviors",{"count":54,"type":21},1500,[24],"This study evaluates the effectiveness of Pathfinding, a 6-month, remotely-delivered case management intervention designed to decrease suicidal behavior among active-duty Regular Army soldiers recently discharged from inpatient psychiatric treatment. Soldiers discharged from military treatment facilities across the U.S. will be identified and recruited to participate. Those who consent will be randomly assigned to receive either Treatment As Usual (TAU), which is the Army's standard post-discharge care, or TAU plus Pathfinding. Participants will complete a baseline assessment and follow-up assessments 6 months and 12 months later. The 6- and 12-month follow-up periods will also include examination of participants' electronic healthcare data and Army administrative data. The overall goals of the study are: (1) to evaluate whether Pathfinding decreases suicidal behaviors among soldiers transitioning from psychiatric hospitalization back to the community; and (2) to determine which discharged soldiers are most likely to benefit from the Pathfinding intervention versus TAU alone.",[58,59],"Suicide","Suicide Attempt",[61,62,63,64,65,66],"suicide","suicide attempt","hospital discharge","military","intervention","case management","2026-06-08",{"date":34,"type":37},{"date":70,"type":37},"2026-02-24",{"date":72,"type":21},"2029-08-31",{"name":43,"class":44},{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},"100639093","blast-overpressure-longitudinal-study-100639093","NCT07606651","Blast Overpressure Longitudinal Study","Blast Overpressure Longitudinal Exposure Study (BLES)","BLES","Inclusion Criteria:\n\n* Active duty\n* U.S. SOF personnel\n* 18-50 years old\n\nExclusion Criteria:\n\n* Subjects will be excluded only if their participation will significantly interfere with validity of data collection or safety during the study (e.g., they have conditions that might result in harm or injury during research procedures).\n* Example: pregnancy (balance considerations)\n* Example: being unable to undergo MRI testing (i.e., they have non-MRI compatible devices, imbedded metal fragments such as shrapnel, and\u002For severe claustrophobia; these MRI contraindications will be screened using an MRI Safety Questionnaire)","50 Years",{"count":84,"type":21},250,"OBSERVATIONAL","The goal of this observational study is to learn about the impact of low-level blast exposure in U.S. Special Operations Forces personnel. The main questions it aims to answer are:\n\nWhat advanced brain imaging changes are related to clinical presentation after low-level blast exposure? What are the relationships between low-level blast exposure and common groups of symptoms after concussion?\n\nParticipants will:\n\n* Undergo advanced brain imaging\n* Answer questionnaires\n* Complete clinical tests\n* Provide blood, urine, and saliva samples\n* Wear blast sensors",[88],"Low-level Blast Exposure",[90,91,92,93,94,95],"traumatic brain injury","concussion","magnetic resonance imaging","blast overpressure","low-level blast exposure","repeated blast exposure","NOT_YET_RECRUITING","2026-05-18",{"date":99,"type":37},"2026-05-26",{"date":101,"type":21},"2026-05",{"date":103,"type":21},"2030-08",{"name":43,"class":44},3,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":22,"phases":117,"briefSummary":118,"conditions":119,"keywords":126,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},"100615129","insight-insomnia-nightmares-and-sympathetic-hyperactivity-intervention-100615129","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.","62 Years",{"count":116,"type":21},180,[24],"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.",[120,121,122,123,124,125],"Nightmare","Insomnia","PTSD","TBI","Sleep Disorder (Disorder)","REM Behavior Disorder",[127,128,129,130,131,121,122,132],"Nightmares","Wearables","Intervention","Sleep quality","Hyperarousal","Healthy Participants","2026-04-27",{"date":135,"type":37},"2026-04-28",{"date":137,"type":21},"2026-06-01",{"date":139,"type":21},"2027-12",{"name":43,"class":44},2,{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":149,"enrollmentInfo":150,"targetDuration":4,"studyType":22,"phases":152,"briefSummary":155,"conditions":156,"keywords":159,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":172,"locationsCount":45},"100616138","phase-1-low-tech-treatments-for-obstructive-sleep-apnea-100616138","NCT07301710","Low-Tech Treatments for Obstructive Sleep Apnea","Myofunctional Therapy for Obstructive Sleep Apnea in U.S. Service Members With and Without Traumatic Brain Injury","Inclusion Criteria:\n\n* New diagnosis of OSA (AHI, ≥ 5) or failure of first-line OSA treatment;\n* Willingness to forego first-line OSA treatment or stop current OSA treatment for 3 months;\n* Ability to follow directions and perform the required exercises;\n* Age between 18-65 yr.\n\nExclusion Criteria:\n\n* Current use of OSA treatment;\n* Medical comorbidities that require restricting fluid intake (e.g., dysphagia, renal disease, liver disease, hyponatremia);\n* Severe nasal obstruction; 4) severe ankyloglossia; 4) craniofacial abnormality; 5) severe pulmonary disease; 6) severe post-traumatic stress disorder; 7) very severe insomnia; 8) body mass index (BMI) ≥30 kg\u002Fm2","65 Years",{"count":151,"type":21},60,[153,154],"PHASE1","PHASE2","The overall purpose of this study is to compare changes in sleep outcomes in people with obstructive sleep apnea (OSA) depending on their participation in one of two behavioral interventions; both involve drinking water and breathing. A second purpose is to compare outcomes between people who have sustained a traumatic brain injury (TBI) and those with no history of TBI. The main questions it aims to answer are whether sleep quality improves after 3-months of high-resistance versus low-resistance exercises, and whether people have different outcomes depending on their history of TBI.",[157,158],"Obstructive Sleep Apnea (OSA)","Traumatic Brain Injury (TBI)",[160,161,162,163,164,165],"Obstructive Sleep Apnea","Myofunctional Therapy","Traumatic Brain Injury","Randomized Controlled Trial","Oropharyngeal Exercises","Respiratory Resistance Training","2026-02-11",{"date":168,"type":37},"2026-02-17",{"date":170,"type":37},"2026-01-29",{"date":139,"type":21},{"name":43,"class":44},{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":22,"phases":182,"briefSummary":183,"conditions":184,"keywords":190,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":202,"locationsCount":45},"100615004","life-skills-training-for-soldiers-arriving-at-their-first-duty-location-100615004","NCT07286955","Life Skills Training for Soldiers Arriving at Their First Duty Location","SAFEGUARD: Life Skills Training for Soldiers Arriving at Their First Duty Location","Inclusion Criteria:\n\n* Active duty Soldiers arriving at a military installation located in the South Central U.S. for their first duty location who are attending reception center activities\n\nExclusion Criteria:\n\n* Soldiers who are not available to attend the in-person training\n* Soldiers who are under the age of 18 years old\n* Soldiers who do not have a smart phone that supports installation of the mobile app",{"count":181,"type":21},5000,[24],"This project will evaluate the effectiveness of Level Up: Boost Your Life Skills (\"Level Up\"), a strengths based, military-specific life skills training program. The goal is to determine whether Level Up can decrease suicidal-related behaviors (SRBs) and other harmful behaviors, improve mental health, enhance job performance, and reduce early military separation. The Level Up program components will be made available to participants through an online platform or mobile app that can be downloaded onto their personal mobile devices. These training materials will help Soldiers learn and practice skills. The Level Up program will also involve personalized messages from a Level Up trainer and virtual booster sessions. Soldiers arriving at their first duty location will be randomized to receive either Level Up or a single session Army bystander intervention program. Participants will complete baseline and follow up surveys 1, 3, and 6 months post-baseline.",[185,186,187,188,27,189],"Risk Reduction Behavior","Suicide Prevention","Risky Behavior","Mental Health","Performance at Work",[191,186,192,193,194,30,31,32,195],"Military Health","Harmful Behaviors","Life Skills Training","First Duty Location","Level Up","2026-01-09",{"date":198,"type":37},"2026-01-13",{"date":200,"type":37},"2025-12-10",{"date":41,"type":21},{"name":43,"class":44},{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":211,"conditions":212,"keywords":215,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":45},"100613532","efficacy-of-xeomin-for-migraines-in-patients-with-traumatic-brain-injuries-vs-anomalous-health-incidents-100613532","NCT07267819","Efficacy of Xeomin for Migraines in Patients With Traumatic Brain Injuries vs. Anomalous Health Incidents","The Efficacy of Xeomin as a Prophylactic Therapy for Migraine in Patients With Traumatic Brain Injuries (TBIs) Versus Anomalous Health Incidents (AHIs)","Inclusion Criteria:\n\n* At least 18 years of age\n* Able to provide written consent in English\n* An employee of the US Government, or an adult family member of a US Government employee\n* Have received Xeomin treatment to prevent migraine related to TBI or AHI at a Military Treatment Facility or other US Medical Facility\n* Able to participate in at least 80% of the assessments\n* A US Citizen and not a dual national of the country where you are currently located\n\nExclusion Criteria:\n\n* Prisoner\n* Decisionally impaired and unable to provide informed consent\n* Non-US citizen",{"count":151,"type":21},"This cohort study aims to compare the efficacy of Xeomin injections for migraine management in patients with a history of Traumatic Brain Injury (TBI) versus those with a history of Anomalous Health Incidents (AHI). The study will be conducted at the National Intrepid Center of Excellence (NICOE) in Bethesda, MD. The primary objective is to determine if Xeomin injections result in different outcomes for migraine management between TBI and AHI patients. This is a combined retrospective and prospective cohort study design. Patients scheduled for Xeomin treatments will be categorized into TBI and AHI groups. For the prospective cohort, participants will complete a baseline questionnaire, receive their scheduled Xeomin treatment, and participate in follow-up interviews at 4-6 weeks and 10-12 weeks post-treatment. For the retrospective cohort, similar information will be acquired from existing records. Statistical analysis will compare migraine characteristics and treatment responses between the two groups. All data will be de-identified to protect patient privacy.",[213,162,214],"Migraine","Anomalous Health Incidents",[216,217,218,213,219],"Anomalous health incident","Traumatic brain injury","Headache","Botulinumtoxin","2025-11-24",{"date":222,"type":37},"2025-12-05",{"date":224,"type":37},"2025-08-05",{"date":226,"type":21},"2028-06-06",{"name":43,"class":44},{"id":229,"slug":230,"hasResults":11,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":234,"eligibilityCriteria":235,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":236,"enrollmentInfo":237,"targetDuration":4,"studyType":22,"phases":239,"briefSummary":240,"conditions":241,"keywords":242,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":141},"100602280","telehealth-for-sleep-apnea-effectiveness-implementation-and-cost-in-the-military-health-system-100602280","NCT07121452","Telehealth for Sleep Apnea: Effectiveness, Implementation, and Cost in the Military Health System","Tele-Sleep OSA: Clinical Effectiveness, Implementation, and Economic Impact of Telehealth Care for Obstructive Sleep Apnea in the Military Health System","TS OSA","Inclusion Criteria:\n\n1. Age 18-64 years\n2. ADFM or DEERS beneficiary\n3. Enrolled in any TRICARE (Prime, Standard, or Extra)\n4. Deferred to private sector care (i.e., local TRICARE network) for OSA care\n5. Newly diagnosed with OSA (AHI\\>5)\n6. Access to smartphone, desktop, laptop, or tablet computer\n\nExclusion Criteria:\n\n1. History of prior OSA testing, diagnosis, or care\n2. Contraindication for home sleep apnea testing, based on established AASM criteria\n3. History of or high-risk for organic sleep disorders other than OSA (e.g., REM behavior disorder, obesity hypoventilation syndrome)\n4. Active alcohol or substance dependence\n5. Severe sleepiness (Epworth Sleepiness Scale \\[ESS\\]\\>18, or clinician judgment)\n6. Pending permanent family change of station (PCS) within 6 months\n7. Active-duty military service members (ADSM)\n8. Untreated major medical or psychiatric illness\n9. Pursuit of non-PAP treatment for OSA","64 Years",{"count":238,"type":21},160,[24],"The long-term goal of this research is to improve military health and operational readiness among military service members with sleep disorders. The overall objective of the current study is to 1) determine the clinical effectiveness (non-inferiority) and cost-effectiveness of OSA telehealth care, including a human sleep navigator (vs private sector care), and 2) to perform a formative evaluation of the implementation of the OSA telehealth care intervention within the National Capitol Region (NCR) market. The central hypothesis is that OSA telehealth care including a human sleep navigator is clinically non-inferior to private sector care and also more cost-effective than private sector care. The investigators plan to achieve the objectives via these 3 Specific Aims: Specific Aim 1: To determine the clinical effectiveness (non-inferiority) of OSA telehealth care, relative to private sector care. Hypothesis 1a: Relative to private sector care, OSA telehealth care is non-inferior for achieving PAP adherence (primary endpoint).\n\nHypothesis 1b: Relative to private sector care, OSA telehealth care is non-inferior for reducing OSA symptoms and for patient satisfaction (secondary endpoints).\n\nSpecific Aim 2: To engage participants via qualitative focus groups and conduct a formative evaluation of the implementation of the OSA telehealth care intervention, using a standardized approach based on the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework.\n\nSpecific Aim 3: To perform a cost-effectiveness analysis of OSA telehealth care from the DHA perspective.\n\nHypothesis 3: Relative to private sector care, OSA telehealth care is more cost-effective.",[157],[243,244,245,246,247],"sleep","sleep apnea","treatment","telehealth","implementation","2025-11-05",{"date":250,"type":37},"2025-11-10",{"date":252,"type":37},"2025-10-15",{"date":254,"type":21},"2028-06-30",{"name":43,"class":44},{"id":257,"slug":258,"hasResults":11,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":262,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":22,"phases":265,"briefSummary":266,"conditions":267,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":45},"100458049","computer-monitor-vs-augmented-reality-3mdr-for-ptsd-ptsd-a-randomized-controlled-trial-100458049","NCT05244564","Computer Monitor vs Augmented Reality 3MDR for PTSD PTSD: A Randomized Controlled Trial","Computer Monitor Versus Augmented Reality: Expanding 3MDR Therapy for PTSD","CARE4PTSD","Inclusion Criteria:\n\n* Service member, veteran, retiree, or DEERS-eligible dependent, male or female, at least 18 years or older\n* Diagnosis of PTSD, as confirmed by the CAPS-5\n* Able to ambulate with contact guard assistance or less, and walk unassisted on a treadmill, at a normal pace, for up to 90 minutes continuously\n\nExclusion Criteria:\n\n* History of epilepsy or a seizure disorder, other than febrile seizures that occurred during childhood and have not recurred since\n* History of a psychotic disorder, bipolar disorder, or active suicidal or homicidal ideation\n* Use of benzodiazepines on a regular basis within the previous 30 days",{"count":151,"type":21},[24],"This is a prospective randomized controlled trial comparing two ways of delivering Motion-assisted, Multi-modular Memory Desensitization and Reconsolidation (3MDR) therapy for posttraumatic stress disorder (PTSD). The study seeks 60 volunteers who have PTSD and are eligible for care in the Department of Defense healthcare system. There will be 10-14 therapy sessions that are 60-90 minutes long, about once a week, and symptoms will be assessed before and after the therapy as well as 3 and 6 months after completing therapy. 3MDR asks you to choose pictures and music that are integrated into a virtual reality environment. You will be walking on a treadmill throughout each therapy session, while the therapist stands next to the treadmill and asks you questions about the pictures you chose.",[268],"Stress Disorders, Post-Traumatic","2025-07-14",{"date":271,"type":37},"2025-07-15",{"date":273,"type":37},"2023-04-30",{"date":275,"type":21},"2027-10-30",{"name":43,"class":44},{"id":278,"slug":279,"hasResults":11,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":283,"eligibilityCriteria":284,"healthyVolunteers":11,"sex":17,"minAge":285,"maxAge":236,"enrollmentInfo":286,"targetDuration":4,"studyType":22,"phases":288,"briefSummary":289,"conditions":290,"keywords":291,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":45},"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","22 Years",{"count":287,"type":21},30,[154],"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.",[120],[127,121,122,292,293,294,295,296,297],"Heart Rate Variability","Electrodermal Activity","BDNF","Cortisol","ACTH","Treatment","2025-03-25",{"date":300,"type":37},"2025-03-30",{"date":302,"type":37},"2024-06-11",{"date":304,"type":21},"2026-03",{"name":43,"class":44},{"id":307,"slug":308,"hasResults":11,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":236,"enrollmentInfo":314,"targetDuration":4,"studyType":22,"phases":316,"briefSummary":317,"conditions":318,"keywords":320,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":141},"100551654","the-effect-of-omega-3-fortified-smoothies-on-omega-3-index-and-physical-performance-related-outcomes-among-soldiers-100551654","NCT06462898","The Effect of Omega-3 Fortified Smoothies on Omega-3 Index and Physical Performance Related Outcomes Among Soldiers","Evaluate the Use of Omega-3 Fortified Smoothies to Improve Omega-3 Index and Physical Performance Related Outcomes Among Soldiers","H2FO3","Inclusion Criteria:\n\n* Active Duty Military Personnel\n* Current soldier at Ft. Drum or Ft. Campbell.\n* Able and willing to complete two Army Combat Fitness Test (ACFT) (Week 1 and week 8)\n* Willing to obtain two finger pricks for the Omega-3 Index (week 1 and week 8)\n\nExclusion Criteria:\n\n* Allergic to fish",{"count":315,"type":21},100,[24],"The goal of this clinical trial is to test the effect of omega-3 on physical performance and recovery of Soldiers.\n\nObjectives 1: Assess the impact of 8-weeks of daily consumption of 1600mg of omega-3 fortified smoothie on O3I response.\n\nObjective 2: Determine the relationship between O3I and measures of performance and recovery.\n\nParticipants will:\n\n* Be randomly assigned to placebo group or to the omega-3 fortified smoothie group.\n* The intervention group will take omega-3 fortified smoothies and controls will consume a non-fortified smoothie, five days a week for 8 weeks.\n* Participate in Army Combat Fitness Tests (ACFT)\n* Complete surveys that assess dietary intake, physical activity (PAQ) and sleep quality (PSQI).\n* Complete a finger prick to determine omega-3 index.\n\nAssessments will be collected pre\u002Fpost intervention. Researchers will compare intervention and placebo groups to see if omega-3 levels increase, and improve physical performance and recovery.",[319],"Nutrition, Healthy",[321,322,323,324,325,326],"Omega-3 fatty acids","Holistic Health and Fitness (H2F)","Army Combat Fitness Test (ACFT)","Performance","Nutrition","Recovery","2024-06-14",{"date":329,"type":37},"2024-06-18",{"date":331,"type":37},"2024-02-01",{"date":333,"type":21},"2024-09-30",{"name":43,"class":44},{"id":336,"slug":337,"hasResults":11,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":4,"eligibilityCriteria":341,"healthyVolunteers":16,"sex":342,"minAge":18,"maxAge":4,"enrollmentInfo":343,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":345,"conditions":346,"keywords":348,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":105},"100445382","comparative-performance-of-a-vaginal-yeast-test-100445382","NCT05079711","Comparative Performance of a Vaginal Yeast Test","Comparative Performance of the SavvyCheck Vaginal Yeast Test Versus Culture","Inclusion Criteria:\n\nSymptomatic Women Symptomatic women include those women who present with a complaint consistent with symptoms of vaginitis (e.g., increased vaginal discharge, vaginal itching, vaginal soreness and irritation, rash on the labia, and genital burning that may worsen during urination). Enrollment will continue at each clinical site until our target number of 216 Reference Method (vaginal Candida yeast culture) positives have been collected. We estimate up to 600 symptomatic women will be enrolled to meet our target.\n\nInclusion Criteria for Symptomatic Women\n\n1. DoD Military Health System beneficiary\n2. Have a healthcare appointment at a recruitment clinic\n3. 18 years of age or older\n4. Must speak and understand English\n5. Able to provide informed consent\n6. Women experiencing vaginal symptoms, including: increased discharge, itching, soreness and irritation, rash on the labia, and genital burning that may worsen during urination\n7. Must determine the test is applicable to her based on her symptoms after she has read the outside device labeling (box label)\n\nAsymptomatic Women Asymptomatic women include those women who do not present with a complaint consistent with vaginitis. Enrollment will continue at each clinical site until our target number of 170 Reference Method (vaginal Candida yeast culture) negatives have been collected. We estimate up to 320 asymptomatic women will be enrolled to meet our target.\n\nInclusion Criteria for Asymptomatic Women:\n\n1. DoD Military Health System beneficiary\n2. Have a healthcare appointment at a recruitment clinic\n3. 18 years of age or older\n4. Must speak and understand English\n5. Able to provide informed consent\n6. Healthy women appearing for routine care without symptoms of vaginal yeast infection\n\nExclusion Criteria:\n\nIf any of the following criteria are met, a potential subject will be excluded from the study:\n\n1. Currently menstruating\n2. History of any clinical therapies and\u002For interventions related to gender confirmation (transgender person)\n3. Use of any vaginal medication, taken by mouth or vaginally, within the last 7 days\n4. Use of any vaginal product within 24 hours, including contraception (cream, gel, or foam), or douching solutions\n\nNOTE: Women who currently have an intrauterine device (IUD) placed are eligible to participate","FEMALE",{"count":344,"type":21},1200,"The purpose of this study is to establish lay user performance criteria for the SavvyCheck Vaginal Yeast Test in comparison to standard vaginal yeast culture and identification method for Candida (the Reference Method). Polymerase chain reaction (PCR) and sequencing of fungi will be used as an aid to explain the nature of the discrepancy in the case of discordant results between the lay user-performed SavvyCheck Vaginal Yeast Test and standard vaginal yeast culture and identification method for Candida.",[347],"Vulvovaginal Candidiasis",[349],"Vaginal candidiasis, Vaginal yeast culture","2024-05-14",{"date":352,"type":37},"2024-05-16",{"date":354,"type":37},"2022-03-18",{"date":356,"type":21},"2026-08-30",{"name":43,"class":44},""]