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临床试验/NCT06826781
NCT06826781招募中不适用

Evaluating Q-Collar Effects on Cerebrovascular Control in Response to Exercise

Spaulding Rehabilitation Hospital2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年7月23日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
2
主要终点
Sit-to-Stand Test: Autoregulatory Slope

研究概览

简要总结

The goal of this clinical trial is to learn how the FDA-cleared Q-Collar device affects brain blood flow regulation during rest and exercise in healthy adults. The main questions this study aims to answer are:

  1. How does the Q-Collar affect brain blood flow when there are quick changes in blood pressure, like when standing up quickly, or when breathing against resistance?
  2. How does the Q-Collar affect brain blood flow during exercise?

Researchers will compare sessions where participants wear the Q-Collar to sessions where they do not wear the device to see if the Q-Collar improves brain blood flow during both rest and exercise.

Participants will:

  • Complete two study visits, each 1 to 4 weeks apart.
  • Perform a series of tasks, including standing tests, breathing tests, and exercise on a stationary bike, while their heart rate, brain blood flow, and other body functions are monitored.
  • Wear the Q-Collar during one of the sessions and not wear it during the other session. The order of the sessions will be randomly assigned.

详细描述

We are doing this research to improve our understanding of how a FDA-cleared device, called the Q-Collar, affects brain blood flow regulation both at rest and in response to exercise. Participants will be asked to complete two study visits over a period of 1 to 4 weeks. Each visit will involve identical assessments, with the Q-Collar worn during one session and not during the other. The order of the sessions will be randomly assigned.

Each visit consists of three main tasks:

Standing Test (approximately 10 minutes): Participants will perform a series of movements, standing up from a seated position, while heart rate, breathing, and brain function are monitored. This test will be repeated three times per session.

Resistive Breathing Test (approximately 10 minutes): Using a mouthpiece that controls breathing difficulty, participants will breathe at specific depths and rates while sensors track gases, heart, lung, and brain activity. This task will be completed once per session.

Stationary Biking Exercise Test (approximately 30 minutes): Participants will perform an exercise test on a stationary bike while monitors measure heart rate, breathing gases, blood pressure, and brain blood flow. The test begins with a 2-minute warm-up, followed by progressively more challenging pedaling, with resistance adjusted based on body weight. Difficulty increases every 1 to 2 minutes until the required pace can no longer be maintained. Periodic ratings of exertion will be recorded. The session concludes with a 2-minute cool-down after maximum effort is reached.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • healthy individuals between the ages of 18 to 30 years old

排除标准

  • History of concussion or other brain injury resulting in loss or alteration in consciousness or other change in cognition within 24 months of study visit
  • High cardiac risk according to the American College of Sports Medicine (ACSM)11
  • Ongoing active treatment with a cardioactive drug
  • Inability to stand from a seated position unassisted
  • History of a neurologic disorder or neurosurgery intervention
  • Pregnancy
  • Any current, serious, chronic medical or psychiatric disease that in the Principal Investigator's or co-investigator's judgment may interfere with study participation or data integrity
  • Unable or unwilling to provide informed consent

结局指标

主要结局

Sit-to-Stand Test: Autoregulatory Slope

时间窗: 2 study visits within a 4 week time frame

The slope of the autoregulatory curve, representing the change in cerebral blood flow in response to rapid shifts in blood pressure during the sit-to-stand transition.

Resistance Breathing Test: Autoregulatory Gain

时间窗: 2 study visits within a 4 week time frame

The autoregulatory gain, which reflects the brain's ability to maintain stable cerebral blood flow during sinusoidal fluctuations in blood pressure induced by resistance breathing.

Graded Bike Test: Change in Cerebral Blood Flow

时间窗: 2 study visits within a 4 week time frame

The change in cerebral blood flow velocity (CBFV) during the graded exercise test, assessed by Transcranial Doppler ultrasonography, indicating how cerebral blood flow responds to increasing physical exertion.

次要结局

未报告次要终点

研究者

发起方
Spaulding Rehabilitation Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

J. Andrew Taylor

PhD

Spaulding Rehabilitation Hospital

研究点 (2)

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