[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07667309":3,"trial-entities:NCT07667309":115,"trial-summary:NCT07667309":119},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":29,"interventions":32,"primary_outcomes":39,"secondary_outcomes":50,"sex":64,"minimum_age":65,"maximum_age":66,"healthy_volunteers":67,"eligibility_criteria":68,"std_ages":72,"locations":75,"central_contacts":108,"overall_officials":111,"references":113,"see_also_links":114},"NCT07667309","STUDY00002535","The Effects of Stellate Ganglion Block Sleep in U.S. Active Duty Service Members and Veterans Receiving Prolonged Exposure Therapy for PTSD","The Effects of Stellate Ganglion Block on Sleep in U.S. Active Duty Service Members and Veterans Receiving Prolonged Exposure Therapy for Posttraumatic Stress Disorder (PTSD)","RECRUITING","2027-06-30","2026-06","2026-06-25","2026-06-15","The University of Texas Health Science Center at San Antonio","OTHER",true,"Participants in this study will have already been enrolled in another research study: Combining Stellate Ganglion Block with Prolonged Exposure for PTSD, NCT05889741. The investigators are using a Sleep Profiler, EEG headband to monitor a participants brainwaves while they sleep to see what effects the Stellate Ganglion Block injection has on their sleep. Participants will wear the headband for 3 nights before the injection and then 3 nights after the injection. Participants will also complete self-report questionnaires regarding their sleep prior to the injection and following the injection. Approximately 40 participants will be included in this study. This study is a nested observational study whereby participants in the parent study who elect to participate will have their sleep assessed using the EEG headband device and self-reported sleep measures performed.","Objectives: The primary objective of this project is to observe the impact of stellate ganglion block (SGB) on objective measures of sleep (using a wearable headband) and subjective measures of sleep (self-report measures) in active duty service members and veterans receiving prolonged exposure therapy (PE) for PTSD. The secondary objective is to evaluate sleep improvements as a mechanism for PTSD treatment outcomes in this population.\n\nSpecific Aim 1: To compare the effects of a SGB with ropivacaine (active) versus a SGB with saline (sham) on objective measures of sleep macroarchitecture (i.e., rapid eye movement \\[REM\\] sleep and slow wave sleep) and sleep continuity (i.e., sleep onset latency, wake after sleep onset, number of awakenings, total sleep time, and sleep efficiency).\n\nSpecific Aim 2: To compare the effects of SGB (active)+PE versus SGB (sham)+PE on sleep microarchitectural indicators of heightened central nervous system arousal (i. e., high-frequency and low-frequency power spectral density, frequency of occipital alpha-indexed micro-arousals, slow wave features \\[e.g., slope, density\\] during N3 sleep, proportion of phasic and tonic REM sleep and REM density during REM sleep).\n\nSpecific Aim 3: Specific Aim 3: To evaluate the effects of SGB (active)+PE versus SGB (sham)+PE on self-reported measures of insomnia and nightmares.",[19],"Post Traumatic Stress Disorder PTSD",[21,22,23,24,25],"Stellate Ganglion Block","Sleep Profiler","PTSD","Sleep","Sleep architecture","OBSERVATIONAL",null,[],{"count":30,"type":31},40,"ESTIMATED",[33],{"type":14,"name":34,"description":35,"armGroupLabels":36},"Sleep Profiler Headband","The headband is worn for 3 nights prior to injection and then for a an additional 3 nights after the injection. Efficacy of the headband is not being tested, it is used as a measuring tool.",[37,38],"Massed PE Exposure with Sham SGB","Massed Prolonged Exposure (PE) with SGB group",[40,44,47],{"measure":41,"description":42,"timeFrame":43},"Total Sleep Time","Time spent asleep from sleep onset to waking time","Sleep onset to awakening time (approximately 8 hours)",{"measure":45,"description":46,"timeFrame":43},"Wake time after sleep onset","Percentage of time spent awake after sleep onset",{"measure":48,"description":49,"timeFrame":43},"Rapid Eye Movement (REM) sleep state","Percentage of sleep time spent in REM",[51,55,58,61],{"measure":52,"description":53,"timeFrame":54},"Insomnia Severity Index","7-item self-report measure that assesses perceived severity of insomnia. Each item uses a 4-point Likert type scale from 0 to 4. The items sum to produce a total score (range 0 - 28) with a higher score indicating","Baseline to 1 month",{"measure":56,"description":57,"timeFrame":54},"Nightmare Disorder Index (NDI)","The 5-item NDI evaluates for nightmare disorder in accordance with the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria. Items are scored from 0-4 to give a total range between 0-20.\n\nHigher scores on the NDI indicate greater nightmare severity.",{"measure":59,"description":60,"timeFrame":54},"Split Week Self-Assessment of Sleep Survey (SASS-Y) for Workdays","The Split Week SASS (SASS-Y) is a retrospective measure that assesses sleep parameters similar to a sleep diary including time to bed, number of awakenings, time of final awakening, and time out of bed, etc. The Split Week version asks participants to estimate these parameters based on workdays.",{"measure":62,"description":63,"timeFrame":54},"Split Week Self-Assessment of Sleep Survey (SASS-Y) for off Days","The Split Week SASS (SASS-Y) is a retrospective measure that assesses sleep parameters similar to a sleep diary including time to bed, number of awakenings, time of final awakening, and time out of bed, etc. The Split Week version asks participants to estimate these parameters based on days off of work.","ALL","18 Years","65 Years",false,{"inclusion":69,"exclusion":70,"raw_text":71},[],[],"Inclusion Criteria:\n\n1. Ability to provide informed consent and follow study-related instructions.\n2. Be randomized into the study titled \"Combining Stellate Ganglion Block with Prolonged Exposure for PTSD: A Randomized Clinical Trial.\" NCT05889741\n3. Indicates willingness to wear the Sleep Profiler sleep monitor and to complete self-report assessments.\n\nExclusion Criteria:\n\n1\\. Pre-existing skin or soft tissue condition that precludes the ability to wear the Sleep Profiler headband.",[73,74],"ADULT","OLDER_ADULT",[76,95],{"facility":77,"status":8,"city":78,"state":79,"zip":80,"country":81,"contacts":82,"geoPoint":92},"Carl R. Darnall Army Medical Center at Fort Hood","Killeen","Texas","76544","United States",[83,88],{"name":84,"role":85,"phone":86,"email":87},"Jennifer D Hein, MD","CONTACT","254-553-9779","jennifer.m.hein6.mil@health.mil",{"name":89,"role":85,"phone":90,"email":91},"Kristi E Pruiksma, PhD","(210) 562-6700","pruiksma@uthscsa.edu",{"lat":93,"lon":94},31.11712,-97.7278,{"facility":96,"status":8,"city":97,"state":79,"zip":98,"country":81,"contacts":99,"geoPoint":105},"University of Texas Health Science Center at San Antonio","San Antonio","78229",[100,103],{"name":101,"role":85,"phone":102,"email":91},"Kristi Pruiksma, PhD, DBSM","210-562-6700",{"name":101,"role":104},"PRINCIPAL_INVESTIGATOR",{"lat":106,"lon":107},29.42412,-98.49363,[109],{"name":110,"role":85,"phone":90,"email":91},"Kristi E Pruiksma, PhD, DBSM",[112],{"name":110,"affiliation":13,"role":104},[],[],{"nct_id":4,"conditions":116,"biomarkers":118},[117],"Post-Traumatic Stress Disorder",[],{"nct_id":4,"found":15,"summary":120,"prompt_version":130},{"design":121,"status":122,"heading":123,"summary":124,"follow_up":125,"word_count":126,"commitments":127,"compensation":128,"drugs_mentioned":129},"This is an observational study involving about 40 participants. You must already be enrolled in a randomized clinical trial (NCT05889741) that compares active SGB with ropivacaine to sham SGB with saline.","completed","Sleep Monitoring for Stellate Ganglion Block in PTSD Treatment","This study is looking at how a treatment called Stellate Ganglion Block (SGB) affects sleep in U.S. active duty service members and veterans who are also receiving Prolonged Exposure (PE) therapy for Post-Traumatic Stress Disorder (PTSD). SGB involves an injection of either ropivacaine (active) or saline (sham) near a cluster of nerves in the neck. You would wear a special headband called a Sleep Profiler for three nights before the injection and three nights after to measure your sleep patterns. Researchers will also ask you to complete questionnaires about your sleep. The goal is to see if SGB improves sleep, including total sleep time, how often you wake up, and your REM (Rapid Eye Movement) sleep, and if these sleep improvements help with PTSD. This study is for people aged 18 to 65 who are already participating in another related study (NCT05889741). About 40 people will be included.","Sleep measurements and self-reports are taken around the time of the SGB injection (3 nights before and 3 nights after).",148,"You would wear a Sleep Profiler headband for three nights before your SGB injection and for an additional three nights after. You will also complete self-report questionnaires about your sleep before and after the injection.","Not stated in the trial record.",[],"v2"]