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临床试验/NCT04691518
NCT04691518Enrolling By Invitation不适用

Effect of Acute Intermittent Hypoxia in Healthy Individuals

Shirley Ryan AbilityLab1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2016年11月16日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
32
试验地点
1
主要终点
Change in Grip Strength

研究概览

简要总结

The use of acute intermittent hypoxia (AIH) has been examined in animal and human studies to gain an understanding of its effect on spinal excitability and synaptic strength. Subsequently, the investigators have learned that the use of AIH results in new protein formation and spinal plasticity. The use of acute intermittent hypoxia demonstrates a potential for therapeutic utilization in individuals with neurologic injuries. However, little is known about the effect of AIH in healthy individuals. This work is necessary to understand the mechanisms of AIH-induced plasticity. As such, this research study seeks to evaluate the impact of a single session AIH on upper extremity motor function in healthy individuals.

详细描述

The use of acute intermittent hypoxia (AIH), has been demonstrated, through human and animal studies, to be an effective way of increasing spinal motor excitability and strengthening residual synaptic connectivity. AIH utilizes short duration (<2 min) exposures to reduced oxygen levels (~10% inspired oxygen), with alternating exposures to air with normal oxygen levels (~21% inspired oxygen).

Previous publications demonstrate that AIH is a safe and effective intervention to modify motor function in individual with chronic incomplete spinal cord injuries. The use of AIH has been shown to influence the activation in musculature, within 60-120 minutes of administration. In addition, when coupling AIH with overground gait training, an increase in functional endurance, as evaluated through the 6 minute walk test, and gait speed, as evaluated through the 10 meter walk test, were demonstrated. In addition, the use of hypoxic training has been studied in healthy individuals and athletes; however, literature examining the effect of a single bout of AIH on performance is limited.

Although AIH has proven to be a promising treatment in enhancing spinal excitability and strengthening existing synaptic connections within individuals with chronic spinal cord injuries, further examination also needs to be made on the impact of AIH on motor function in healthy individuals.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

盲法说明

Outcomes assessor will be blinded to Treatment or Placebo treatment when applicable

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • No history of neurologic injury or progressive neuromuscular disorder
  • Individuals ages 18-70 years old
  • Must be medically stable with no history of cardiovascular instability, congestive heart failure or stroke
  • Not currently (>2 weeks) on any medications related to spasticity
  • No history of Sleep apnea
  • Not a current smoker
  • Able to comply with protocol/study requirements

排除标准

  • Recent change in the use of narcotic, anti-inflammatory or pain medication
  • unstable medical conditions or any other clinical observation that may affect the candidate's performance, health, safety or the ability to participate in the study determined by the treating therapist or coordinating staff
  • Active participation in another movement research study or therapy program
  • Anti-spasticity drug injection less than 3 months prior to beginning treatment
  • Musculoskeletal pain that interferes with participation in study
  • Women who are currently, may be, or planning on becoming pregnant
  • for fMRI participation, participants will be excluded if they have:
  • Metal fragments in eyes or face
  • Implantation of any electronic devices such as (but not limited to) cardiac pacemakers, cardiac defibrillators, cochlea implants, or nerve stimulators
  • Vascular surgery
  • Claustrophobia
  • Body piercing or tattoos

结局指标

主要结局

Change in Grip Strength

时间窗: Immediately after acute intermittent hypoxia administration

Change in strength from before acute Intermittent hypoxia to after administration

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zev Rymer

Director Sensory Motor Performance Program

Shirley Ryan AbilityLab

研究点 (1)

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