[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07636720":3,"trial-entities:NCT07636720":103,"trial-summary:NCT07636720":107},{"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":21,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":48,"secondary_outcomes":60,"sex":61,"minimum_age":62,"maximum_age":63,"healthy_volunteers":15,"eligibility_criteria":64,"std_ages":68,"locations":71,"central_contacts":91,"overall_officials":96,"references":101,"see_also_links":102},"NCT07636720","STUDY00000600","Sensing in Sleep Deep Brain Stimulation","Sensing in Sleep and Deep Brain Stimulation","RECRUITING","2028-02-01","2026-06","2026-06-09","2026-02-27","The University of Texas Health Science Center at San Antonio","OTHER",false,"Participants in this study have Parkinson's Disease and already have a device, called the Percept RC Deep Brain Stimulation device implanted. People with Parkinson's disease often have issues related to sleep such as bad quality of sleep, waking up often and sleep apnea (breathing stops and starts during sleep).\n\nFor this study, participants will be sleeping overnight in the study sleep lab for two nights. One night, Deep Brain Stimulation (DBS) device turned on and one night with the DBS off, either in this order or the reverse.","This prospective study will use the Percept sensing tools, collectively referred to as Brainsense, to correlate STN and GPi-LFP activity to sleep stages, characterize sleep events and evaluate the effects of DBS stimulation on sleep quality and sleep events. This study may help identify and validate novel biomarkers to assess sleep quality, REM behavior disorder,sleep fragmentation, and awakenings in patients with Parkinson's Disease, which will support overall DBS' efficacy beyond motor symptoms, and supplement interventions to improve sleep, and potentially also guide more effective DBS programming.",[19,20],"Parkinson's Disease and Parkinsonism","Dyssomnia",[22,23,24],"Deep Brain Stimulation","Polysomnography","Sleep Disorders","INTERVENTIONAL","BASIC_SCIENCE",[28],"NA",{"count":30,"type":31},20,"ESTIMATED",[33,42],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":40},"DEVICE","Polysomnography ON stimulation then OFF","Patients will undergo a 2-night Polysomnography (PSG). Stimulation will be set to \"ON\" stimulation for the 1st PSG night, then will cross over the 2nd PSG study night in the opposite stimulation state. Each subject will act as their own control.",[38,39],"GPi-DBS Group","STN-DBS Group",[41],"PSG ON\u002FOFF",{"type":34,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"Polysomnography OFF stimulation then ON","Patients will undergo a 2-night Polysomnography (PSG). Stimulation will be set to \"OFF\" stimulation for the 1st PSG night, then will cross over the 2nd PSG study night in the opposite stimulation state. Each subject will act as their own control.",[38,39],[47],"PSG OFF\u002FON",[49,53,57],{"measure":50,"description":51,"timeFrame":52},"Sensing & Sleep: Parkinson's Disease Sleep Assessment","A 7 item to rate sleep experience scored 0=unsure, 1=No and 2=Yes. Total range of scores is from 0-14 with a higher score indicating more issues with sleep","Day 1 to Day 14",{"measure":54,"description":55,"timeFrame":56},"Motor severity","Motor severity will be assessed by the Movement Disorders Society - Unified Parkinson's Disease Rating Scale - part III. This scale is the gold standard for measuring the severity and progression of PD. Part III entails motor examination which consists of 18 questions that are scored on a 0-4 scale. Higher scores suggest greater severity and progressing disease.","Baseline to Day 14",{"measure":58,"description":59,"timeFrame":56},"Epworth Sleepiness Scale (ESS)","The ESS is a short, self-administered survey that asks respondents to rate their likelihood of dozing off in eight different situations on a scale of 0-3. The total score ranges from 0-24, and is used to estimate if the respondent has excessive daytime sleepiness that may require medical attention. A score over 10 is abnormal. Higher scores suggest greater severity of daytime sleepiness.",[],"ALL","40 Years","80 Years",{"inclusion":65,"exclusion":66,"raw_text":67},[],[],"Inclusion Criteria:\n\n1. Ability of subject to understand and the willingness to sign a written informed consent document.\n2. Males and females; Age 40-80\n3. Subjects with the diagnosis of idiopathic PD consistent with the United Kingdom Parkinson Disease society brain bank criteria, or documented diagnosis of Parkinson Disease who have a Deep Brain Implant, Percept RC device to subthalamic nucleus (STN) or Globus pallidus internus (GPi).\n4. Willingness to adhere to the PSG regimen and turn DBS off for one night.\n5. A score of ≥23 on the Montreal Cognitive Assessment (MoCA)\n6. Be willing to stop any sleep hypnotics such as benzodiazepines and Ambien, with a 3 day washout period.\n\nExclusion Criteria:\n\n1. History of severe cardiovascular disease, untreated obstructive sleep apnea (OSA).\n2. History of other neurological disorders affecting the central nervous system such as stroke, multiple sclerosis, tumors, amyotrophic lateral sclerosis or muscle disease such as muscular dystrophy, myopathy.\n3. History of Dementia.\n4. Report dopaminergic medication changes in the past month.",[69,70],"ADULT","OLDER_ADULT",[72],{"facility":73,"status":8,"city":74,"state":75,"zip":76,"country":77,"contacts":78,"geoPoint":88},"The University of Texas Health Science Center at San Antonio - Brain Health Center","San Antonio","Texas","78229","United States",[79,84],{"name":80,"role":81,"phone":82,"email":83},"Omalys Biggs Rodriguez","CONTACT","210-450-8456","biggsrodrigu@uthscsa.edu",{"name":85,"role":81,"phone":86,"email":87},"Eleni O Vaou, MD","210-450 8048","vaou@uthscsa.edu",{"lat":89,"lon":90},29.42412,-98.49363,[92,94],{"name":85,"role":81,"phone":93,"email":87},"210 450 8048",{"name":80,"role":81,"phone":95,"email":83},"210-450-7547",[97,99],{"name":85,"affiliation":13,"role":98},"PRINCIPAL_INVESTIGATOR",{"name":100,"affiliation":13,"role":98},"Pablo Coss, MD",[],[],{"nct_id":4,"conditions":104,"biomarkers":106},[105],"Parkinson Disease",[],{"nct_id":4,"found":15,"summary":108,"prompt_version":108},null]