Consciousness Studies and Cardiovascular Health

University of Miami1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2026年10月1日最近更新: 2026年6月2日

试验速览

阶段: 不适用
状态: 尚未招募
发起方: University of Miami
入组人数: 40
试验地点: 1

研究概览研究设计入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

The objective of the study is to evaluate whether a virtual reality (VR) based intervention combining binaural beats, photic stimulation, and real-time biofeedback reduces stress and improves physiological markers compared to non-VR interventions and usual care in patients that go to cardiology clinic.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Supportive Care
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Age 18 and older
•Able to provide informed consent (English only for pilot)
•Chronic Selective Serotonin Reuptake Inhibitors/ Serotonin-norepinephrine reuptake inhibitors (SSRI/SNRI) or Attention Deficit/ Hyperactivity Disorder (ADHD) meds allowed (recorded)
•Normal vision and hearing
•Stable vitals (HR 55-100 bpm, Systolic Blood Pressure (SBP) 90-160mmHg (millimeters of mercury, afebrile)
•Willing to abstain 6 hours pre-session from caffeine, nicotine, heavy exercise
•Willing to tolerate electroencephalogram (EEG) headband, Galvanic Skin Response (GSR) electrodes are small sensors placed on the skin (usually fingers or palm) and virtual reality (VR) headset

排除标准

•History of seizure disorder or photosensitive epilepsy
•Migraine with visual aura
•Retinal disease sensitive to flicker
•Unstable cardiac disease
•Dysautonomia
•Recent sedative use (benzodiazepines, opioids)
•Beta blocker dose changes within last 7 days
•Alcohol or recreational drugs within 12 hours
•Active panic disorder
•Severe motion sickness
•Scalp conditions preventing EEG contact
•Severe visual or hearing impairment Cognitive impairment
•Non-English speakers (pilot in English only)

研究者

发起方

University of Miami

申办方类型

Other

责任方

Principal Investigator

主要研究者

Claudia Martinez

Professor of Clinical Medicine

University of Miami

研究点 (1)

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