跳至主要内容
临床试验/NCT02447731
NCT02447731撤回不适用

The Effects of Sound Energy on Pulmonary Gas Exchange

Loma Linda University1 个研究点 分布在 1 个国家开始时间: 2016年7月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Percent Improvement in PtcO2 & PtcCO2

研究概览

简要总结

Study of the effects of sonic pressure oscillations on pulmonary gas exchange with added dead space.

详细描述

Sound waves are used in various industries to accelerate the process of mixing or separating fluids (gases/liquids). We have proved that certain sound waves can safely improve gas exchange in the lung of rats through accelerating gas diffusion inside their airways and alveoli. Now we want to see if similar sound waves can improve gas exchange in humans.

The device which creates the sound waves is a sonic pressure oscillator capable of making sound waves similar in loudness and frequency to loud human singing or screaming. These waves are mainly in the frequency range of 50-500 Hz (Hertz, oscillations per second) with intensity of 85-105 dBs (deci Bells, unit of sound pressure intensity).

We performed two bench top studies and witnessed the ability of sound waves to augment gas diffusion. In a pilot study in rats we showed a safe and significant improvement in pulmonary gas exchange under influence of sound energy. The effects of sound waves on gas exchange in a human subject, the principle investigator (PI), was also analyzed in a metabolic test with promising results. A clinically significant improvement in the PI's pulmonary gas diffusion was also noted in a DLCO (diffusing lung capacity for carbon monoxide) test. On yet another test, artificially enlarged pulmonary dead space study, the PI's transcutaneous oxygen and carbon dioxide pressures (PtcCO2 & PtcO2) were measured and results were indicative of presence of desired and safe effects of particular sound waves in pulmonary gas exchange. The above mentioned studies support the rationale, objectives, and methodology of the proposed studies.

Our human studies will be composed of a primary and a secondary part. In the primary part, the sound waves are not introduced into the subjects' lungs directly and they are rather delivered into an open end cylinder while the subjects breathe the air from the closed end of the cylinder. The sound intensity will be kept in the range of 95-105dB.

In the second part of the studies, the sound waves of lower intensity (85-95dB) are directly introduced into the subjects' lungs while the subjects are going through 1) a metabolic test and 2) a lung diffusion capacity (DLCO) test. The results of these tests will be compared to the subject's baseline test results (without sound waves).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
21 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy male or female volunteers in the age group.

排除标准

  • Any acute or chronic cardiopulmonary disorder including a simple common cold.

结局指标

主要结局

Percent Improvement in PtcO2 & PtcCO2

时间窗: 1 month

Sonic vibrations similar to human screaming should improve pulmonary gas diffusion by more than 5% in few seconds.

次要结局

  • mL/min exhaled VCO2 and VO2(1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验