Autonomic Dysregulation

Spinal anesthesia-induced hypotension is a common and significant complication affecting up to 50-80% of pregnant women undergoing elective cesarean section. This trial evaluates whether a brief 5-minute mindfulness-based breathing exercise given just before spinal anesthesia can influence blood pressure changes during surgery. The study compares this breathing technique to standard care in pregnant women aged 18 to 45 years scheduled for elective cesarean delivery. Participants will be randomly assigned to either perform the mindfulness-based breathing exercise or receive standard preoperative care. The breathing exercise involves slow diaphragmatic breathing at about six breaths per minute, guided by a trained anesthesiologist or nurse, with mindful repetition of the phrase "My body is relaxing as I exhale." Both groups receive spinal anesthesia with specific medications, and careful monitoring of heart rate and blood pressure is performed. During the study, participants will be closely observed for changes in systolic blood pressure and heart rate within 10 minutes after spinal anesthesia. Anxiety levels, incidence of early hypotension, and medication use to support blood pressure will also be measured. The trial includes standard monitoring such as ECG and oxygen saturation, with safety and response data collected throughout the procedure. Participants' involvement includes a short breathing exercise or equivalent wait time before anesthesia, with follow-up assessments during surgery.

Alpha-synucleinopathies are age-related neurodegenerative disorders characterized by the build-up of alpha-synuclein in nerve cells, leading to conditions like Parkinson's disease, Multiple System Atrophy, and Dementia with Lewy Bodies. Pure Autonomic Failure is a related condition affecting the peripheral autonomic nervous system and may signal risk for developing central nervous system synucleinopathies. Researchers aim to identify biomarkers, especially changes in dopamine production in key brain areas, to predict progression from peripheral to central disease. Participants receive a radiolabeled drug called [18F]F-DOPA, which is used in PET scans to study dopamine activity in the brain. Before the PET scan, patients take oral doses of carbidopa and entacapone to enhance imaging quality by reducing peripheral metabolism of [18F]F-DOPA. The PET scan involves a slow injection of [18F]F-DOPA followed by about 95 minutes of serial brain imaging to observe dopamine-related changes. During the study, participants undergo clinical exams to confirm diagnosis and receive the PET imaging procedure. Researchers measure differences in [18F]F-DOPA uptake across patient groups 95 minutes after imaging starts to assess dopamine function. The study includes patients with autonomic failure, possible synucleinopathies, and healthy adults aged 18 and older. The study is designed to monitor safety and gather detailed imaging data over the scan period.

Researchers are evaluating a combined sleep promotion and cognitive training intervention to help improve cognitive function in older survivors of intensive care units (ICU). This study focuses on adults aged 60 and older who are at high risk for delirium and cognitive decline similar to mild Alzheimer's disease after ICU discharge. The study aims to assess whether these interventions can reduce the risk of developing Alzheimer's disease and related dementias by addressing sleep deficiency, inactivity, and circadian rhythm disturbances common in ICU survivors. Participants will be randomly assigned to one of four groups: a combination of nighttime sleep promotion using earplugs and eye masks plus daily 30-minute computerized cognitive training sessions; cognitive training alone; sleep promotion alone; or an active control group receiving educational modules on brain health. The interventions last up to seven days following ICU discharge, with cognitive training sessions scheduled based on individual circadian rhythms measured by a wearable sensor. During the study, participants will be monitored using body temperature sensors to optimize the timing of cognitive training. Researchers will assess cognitive function, including executive function and working memory, at several time points: within seven days after hospital discharge, and at one, six, and twelve months follow-up. The study also examines how sleep and activity may influence cognitive outcomes, with safety and ongoing care monitored throughout the study period, which concludes in May 2027.

Researchers are evaluating the effects of CST-3056 on symptoms and signs of neurogenic orthostatic hypotension (nOH), a condition causing low blood pressure upon standing. This Phase 2 study focuses on subjects diagnosed with nOH due to Parkinson's disease or pure autonomic failure. The trial aims to better understand how CST-3056 affects orthostatic symptoms compared to placebo under medical supervision. Participants will receive single oral doses of CST-3056 once daily for five days, including three initial dosing days and an Optimal Dose Day determined by monitoring blood pressure and tolerability. Some days include a single dose of placebo for comparison. Before dosing, subjects must stop other similar medications for at least one day or five half-lives. After inpatient dosing, participants will be contacted by phone within a week to check on their health and report any side effects. During the study, participants will undergo assessments of standing and seated blood pressure at multiple times after dosing. They will also have symptom evaluations using the Orthostatic Hypotension Symptom Assessment and a heads-up tilt table test for blood pressure response on the Optimal Dose Day. Safety and tolerability will be monitored throughout. The study participation will last through the dosing days and follow-up call, with health status tracked after discharge.

Researchers are evaluating pyridostigmine compared to a placebo for treating postural tachycardia syndrome (POTS), a condition characterized by rapid heart rate and symptoms like weakness and lightheadedness when standing. This phase 2 study aims to see if pyridostigmine can improve heart rate and stabilize blood pressure in people with POTS. The study is double-blind and placebo-controlled, meaning neither participants nor doctors know who receives the active drug or placebo during the trial. Participants will be randomly assigned to one of two groups: one taking 180 mg of time-release pyridostigmine daily, and the other taking a placebo capsule daily, both for 3 days. The study includes two visits to the outpatient General Clinical Research Center. The first visit lasts about 3 hours, and the second visit occurs 2 days later, lasting about 2 hours. During these visits, various tests and procedures assess autonomic and cardiovascular function. During each visit, participants will undergo a medical and neurological exam, height and weight measurement, and complete questionnaires about autonomic symptoms. Tests include an autonomic reflex screen with sweat gland response, cardiovascular recordings, the Valsalva maneuver, and a head-up tilt test. Blood samples will be taken to measure hormone levels while lying down and after standing. Researchers will measure changes in orthostatic symptoms using the Composite Autonomic Symptom Scale and monitor heart rate and plasma norepinephrine changes. Safety and response will be closely observed throughout the short study period.

Researchers are evaluating the effects of adding clonidine to propofol sedation in patients undergoing colonoscopy. The study aims to compare the safety, patient satisfaction, and efficiency of propofol alone versus propofol combined with clonidine. Colonoscopy is a common procedure used for prevention, diagnosis, and treatment of lower digestive tract conditions, and sedation improves patient comfort and procedure quality. The trial explores how clonidine, which acts on alpha2 adrenoceptors to produce sedation and analgesia, may affect sedation outcomes alongside propofol. Participants will be randomly assigned to one of two groups. One group receives propofol sedation maintained by continuous infusion via syringe pump, starting at 25-75 micrograms per kilogram per minute intravenously for 10 to 15 minutes, then adjusted based on clinical response. The other group receives an intravenous dose of clonidine (2 micrograms per kilogram) 30 minutes before starting propofol sedation, administered over 10 minutes. Sedation onset and dosing are carefully regulated to avoid unnecessary sedative exposure. During the study, patients will be monitored for heart rate and blood pressure throughout the colonoscopy procedure. Patient satisfaction and side effects will be assessed 24 hours after surgery. Researchers will track vital signs until the procedure ends and evaluate overall safety and comfort. The study runs from July to September 2024 and includes adults aged 18 to 65 undergoing colonoscopy with specific health criteria.

Researchers are evaluating an intervention aimed at reducing weight bias internalization (WBI) and weight stigma among adolescents aged 13 to 17 years who have a body mass index (BMI) at or above the 95th percentile for their age and sex. The study will examine whether addressing WBI alongside a behavioral weight management program can improve physical and mental health outcomes, including biological stress markers and eating behaviors. This randomized pilot trial compares this combined intervention to a control group receiving general health information plus weight management. Participants will be randomly assigned to one of two groups. The first group will receive a 4-week program focused on weight stigma and WBI, followed by a 16-week behavioral weight management intervention that integrates WBI content. The second group will receive 4 weeks of health education on topics unrelated to weight, such as smoking cessation and skin cancer prevention, followed by the same 16-week behavioral weight management program without WBI content. Weekly 75-minute sessions are led by behavioral experts, and caregivers participate in four sessions with their teens. During the 20-week study, participants will attend weekly group sessions and undergo assessments at the start, after 4 weeks, and at the end of the program (20 weeks). These assessments include questionnaires measuring WBI, weight-related teasing, and eating behaviors, as well as biological tests for stress and inflammation markers like cortisol, CRP, and IL-6. Researchers will also track attendance, retention, and intervention acceptability. The study aims to gather data for larger future trials focused on adolescent weight management.

This research aims to compare advanced hemodynamic monitoring with standard monitoring during propofol sedation for ERCP procedures, focusing on whether advanced monitoring better detects hemodynamic events needing intervention. ERCP is used mainly for therapeutic treatment of biliary and pancreatic duct disorders, especially in elderly patients who often face hemodynamic challenges during sedation due to comorbidities. Maintaining adequate organ blood flow and oxygen is crucial, and standard monitoring may miss some important hemodynamic changes. The study has two groups: one group receives standard monitoring including non-invasive blood pressure, ECG, pulse oximetry, and BIS without arterial cannulation. The other group receives advanced monitoring using the MostCare system via radial arterial cannulation, capturing detailed parameters like cardiac output, stroke volume, systemic vascular resistance, and cardiac power output. Both groups undergo ERCP under propofol sedation, with advanced monitoring aimed at providing more detailed data to guide interventions. Participants will be adults aged 18 or older with certain physical health status undergoing ERCP while breathing on their own. They will be monitored from the start of sedation until the end of the procedure for hemodynamic events requiring clinical intervention. The study will record the number of such events and compare findings between the two monitoring methods. Consent and continuous monitoring ensure participant safety throughout the procedure.

Researchers are investigating the risk of low blood pressure (hypotension) after anesthesia induction in high-risk patients with serious health conditions, classified as American Society of Anesthesiologists (ASA) physical status 3 or 4. This study compares a new method called target-controlled infusion (TCI) of propofol to the standard manual anesthesia induction. Previous research showed TCI may cause less hypotension in general patients, and this trial continues that work focusing on patients at higher risk. The study involves two groups of patients undergoing major elective surgery. One group receives manual anesthesia induction where propofol is given at a fixed dose based on weight over 1-2 minutes, aiming for a hypnosis level measured by bispectral index (BIS) of 35-60. The other group receives TCI induction where the propofol concentration is computer-controlled and adjusted to maintain a hypnosis level measured by BIS of 35-55. Both groups are monitored using a pressure recording analytical method (PRAM) device to track heart and blood vessel function during and after anesthesia induction. Participants will be monitored closely from one minute before induction to ten minutes after to measure blood pressure and heart function parameters including systolic, diastolic, and mean arterial pressures. Additional heart and circulation data such as arterial elastance, stroke volume variation, and cardiac output are recorded to predict and understand hypotension. This detailed monitoring aims to compare the effects of TCI and manual induction on blood pressure stability in these high-risk patients during anesthesia.

Researchers are studying the impact of monitoring cerebral autoregulation function using regional cerebral oxygen saturation on postoperative neurological complications in patients undergoing carotid endarterectomy (CEA). This surgery treats symptomatic narrowing of the extracranial internal carotid artery but carries a risk of silent strokes detected by MRI shortly after the operation. The study aims to see if real-time monitoring of cerebral oxygen index, which reflects autoregulation, can reduce ischemic brain injury around the time of surgery. Participants are randomly assigned to one of two groups. In the autoregulation group, anesthesiologists maintain the cerebral oxygen index below 0.3 by adjusting blood pressure with norepinephrine or phenylephrine infusions or by modifying oxygen and carbon dioxide levels to improve brain oxygen saturation. In the routine care group, anesthesiologists do not see the cerebral oxygen index and manage blood pressure within 20% of baseline using similar vasoactive drugs, while keeping carbon dioxide and oxygen levels within standard ranges. During the study, participants are evaluated for cerebral ischemic events within 3 days after surgery, with additional assessments including delirium during the first 3 days, cognitive tests before surgery and about 4 to 5 days after surgery, and pain levels at 24, 48, and 72 hours post-surgery. The study enrolls adults aged 18 to 80 scheduled for elective CEA and monitors them closely with brain oxygenation and clinical assessments to understand how cerebral autoregulation management affects recovery and complications.