[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05656768":3,"trial-entities:NCT05656768":81,"trial-summary:NCT05656768":88},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":22,"study_type":28,"primary_purpose":13,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":39,"secondary_outcomes":48,"sex":53,"minimum_age":54,"maximum_age":55,"healthy_volunteers":56,"eligibility_criteria":57,"std_ages":62,"locations":65,"central_contacts":74,"overall_officials":75,"references":79,"see_also_links":80},"NCT05656768","IRB-300010042","Sleep and Circadian Contributions to Nighttime Blood Pressure","ENROLLING_BY_INVITATION","2028-12-30","2026-01","2026-01-29","2023-06-01","University of Alabama at Birmingham","OTHER",false,"Broadly, this study (SCN-BP) seeks to examine sleep and circadian factors that contribute to blood pressure levels at night.","SCN-BP is imbedded in a parent grant titled \"Improving the Detection of Hypertension (IDH-MEGA)\" and examines a variety of sleep (e.g., sleep duration, timing, and the presence of sleep disorder) and circadian factors in Aims 1 and 2. In Aim 3, the investigators will conduct a 30-hour constant routine protocol to directly examine endogenous circadian and blood pressure rhythms. Aims 1 and 2 are purely observation. The study design design described below pertains the intervention piece of this study (Aim 3).",[18,19,20,21],"Sleep","Circadian Rhythm","Blood Pressure","Hypertension",[23,24,25,26,27],"sleep","circadian rhythm","circadian misalignment","nocturnal hypertension","non-dipping blood pressure","INTERVENTIONAL",[30],"NA",{"count":32,"type":33},1427,"ESTIMATED",[35],{"type":13,"name":36,"description":37,"armGroupLabels":38},"Constant Routine Protocol","A constant routine protocol is used to directly examine markers of circadian rhythmicity (e.g., melatonin and core body temperature). A constant routine protocol requires an individual to remain in a dimly lit room, in a constant semi-recumbent posture, and remain awake for more than 24 hours. It is one of two gold-standard research protocols for examining circadian rhythms in humans.",[36],[40,44],{"measure":41,"description":42,"timeFrame":43},"Change in Melatonin","Melatonin levels obtained from saliva samples","Hourly samples obtained over 30 hours",{"measure":45,"description":46,"timeFrame":47},"Change in Core body temperature","Core body temperature","Continuous measurements over 30 hours",[49],{"measure":50,"description":51,"timeFrame":52},"Change in Blood pressure","Systolic and diastolic blood pressure obtained using an ambulatory blood pressure monitor","Measurements obtained every 30 minutes over 30 hours","ALL","18 Years",null,true,{"inclusion":58,"exclusion":60,"raw_text":61},[59],"Participant in the parent grant (IDH-MEGA)",[],"Inclusion Criteria:\n\n* Participant in the parent grant (IDH-MEGA)\n\nExclusion Criteria:\n\n\\-",[63,64],"ADULT","OLDER_ADULT",[66],{"facility":12,"city":67,"state":68,"zip":69,"country":70,"geoPoint":71},"Birmingham","Alabama","35294-0017","United States",{"lat":72,"lon":73},33.52066,-86.80249,[],[76],{"name":77,"affiliation":12,"role":78},"Stephen J Thomas, PhD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":82,"biomarkers":87},[83,21,84,85,86],"Circadian dysregulation","Non-Dipping Blood Pressure","Renal Hypertension","Sleep Disorder",[],{"nct_id":4,"found":14,"summary":55,"prompt_version":55}]