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NCT03132961 · ClinicalTrials.gov registry record
Effects of Infrasound Exposure on Measures of Endolymphatic Hydrops
A clinical trial, sponsored by University of Minnesota.
- Terminated
- Registry status
- 12
- Enrollment target
NCT03132961: Clinical Trial study, sponsored by University of Minnesota.
NCT03132961 is a clinical trial that was terminated before completion, run by University of Minnesota. The registered enrollment target is 12 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03132961 was terminated before completion, sponsored by University of Minnesota.
- TERMINATED
- Registry status
- 12 participants
- Enrollment target
Study Summary
Persons exposed to infrasound - frequencies below 20 Hz - describe a variety of troubling audiovestibular symptoms, but the underlying mechanisms are not understood. Recent animal studies, however, provide evidence that short-term exposure to low frequency sound induces transient endolymphatic hydrops. The existence of this effect has not been studied in humans. The long-term objective of this research is to identify a possible mechanism to describe the effects of infrasound on the human inner ear. The central hypothesis of the proposed study is that short-term infrasound exposure induces transient endolymphatic hydrops in humans. This will be tested by performing electrophysiologic tests indicative of endolymphatic hydrops among normal hearing individuals before and immediately after a period of infrasound exposure. Recordings of infrasound generated by wind turbines in the field have been established and calibrated by this team of engineers, otologist, and hearing and balance scientists. An infrasound generator reproduces the acoustic signature based on these field recordings. Aim 1: Determine the effect of infrasound on the summating potential to action potential (SP/AP) ratio on electrocochleography (ECoG). Hypothesis 1: Infrasound exposure will cause a reversible elevation of the SP/AP ratio. Aim 2: Determine the effect of infrasound on the threshold response curves of ocular and cervical vestibular evoked myogenic potentials. (oVEMP and cVEMP). Hypothesis 2: Infrasound exposure will cause elevation of the oVEMP and cVEMP thresholds at the frequency of best response. Successful completion of the aims will provide evidence for a possible mechanism of the effect of infrasound on the inner ear. This understanding will benefit individuals exposed to environmental infrasound and those in regulatory, research, and advocacy roles when crafting interventions and future policy.
Primary Outcome
A baseline ECoG recording will be obtained and the waveform's SP/AP ratio will be calculated and recorded (time "-10"). A 10-minute infrasound stimulus will ensue. Immediately following cessation of the stimulus (time 10), a repeat ECoG test run will be performed. A 10-minute recovery period will take place followed by a final ECoG test run (time 20). S/P ratios will be recorded for each test run and percent change will be calculated.
Interventions
- OTHER Infrasound exposure
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2018-05-05 |
| Est. Completion | 2018-08-23 |
Why NCT03132961 stopped before completion
NCT03132961 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 12 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Infrasound exposure is the first listed.
NCT03132961 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03132961 about?
NCT03132961 is a clinical study titled "Effects of Infrasound Exposure on Measures of Endolymphatic Hydrops". Persons exposed to infrasound - frequencies below 20 Hz - describe a variety of troubling audiovestibular symptoms, but the underlying mechanisms are not understood. Recent animal studies, however, provide evidence that short-term exposure to low frequency sound induces transient endolymphatic hydro...
What is the current status of trial NCT03132961?
This trial is currently terminated. The enrollment target is 12 participants. The study started on 2018-05-05. Estimated completion is 2018-08-23.
What interventions are being tested in trial NCT03132961?
The interventions under investigation include: Infrasound exposure (OTHER).
Who is sponsoring clinical trial NCT03132961?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
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