Hyperbaric Dosage Analysis Effect Of Various PO2 Exposures: Hyperoxia-Hypoxia Paradox On Stem Cell Mobilization, Cell Signaling, Inflammation, Epigenetics & Cell Regeneration
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Epigenetic Aging
研究概览
简要总结
This study aims to assess the impact of hyperbaric oxygen therapy on a number of outcomes, including epigenetic aging, inflammation, and cellular health.
详细描述
While current research has identified many mechanisms of action, effects and cell signaling benefits resulting from HBOT, we do not have a firm understanding of the timeframe and dosage for many of these expected adaptations. Data from this study will be collected and shared on an ongoing basis throughout the course of care. This research project will help us to confirm these cell-signaling changes and benefits, and also develop a better understanding of the necessary PO2 and time frame required in order to achieve these changes leading to improved patient outcomes in the field of hyperbaric medicine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants, the principal investigator, and outcomes assessor will be blinded to patient's HBOT dosing. Technicians at the clinic will know which treatment dose each participant is receiving in order to deliver appropriate dosing.
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any sex, gender orientation, and ethnicity
- •Between ages 40 and 70
- •Must be willing and able to participate in venipuncture, health history and clinical assessments, lab test assessment, hyperbaric oxygen treatment.
- •Participants must also agree to maintain their current lifestyle choices consistent with pre- participation with this study. Participants should not change their exercise programs, diets, sleep patterns supplements or other. Any significant changes in their lifestyle choices must be reported to the staff.
排除标准
- •Significant change in diagnosis and/or treatment of major illness or injury within 2 years prior to screening, e.g., diabetes, cancer, cardiovascular disease, psychiatric condition
- •Any ongoing immune system concerns or immunodeficiency disease
- •Body mass index (BMI) changes of more than 5% over the course of the study
- •Changes in weight of more than 15 lbs. during the course of the study
- •Presence of a severe active infection as determined by the principal investigator.
- •Any other illness, disorder, alcohol or chemical dependence that in the opinion of investigators would render study participation unsuitable
- •Unable or unwilling to provide required biological sample
- •Unable or unwilling to avoid pregnancy during study period
- •Presence of cataracts before the study begins
- •Myopic changes within the first 30 days of treatment
结局指标
主要结局
Epigenetic Aging
时间窗: Testing will compare baseline with 6 months
DNA methylation of blood samples for epigenetic age
次要结局
- Neurotrax(Testing will compare baseline with 6 months)