The Effects of Ultrasonic Noise Exposure on Human Hearing

December 11, 2018 updated by: Ultrahaptics Ltd

An Investigation of the Effects of Ultrasonic Noise Exposure on the Human Auditory System Via Pure Tone Audiometry (PTA) on Audiometrically Healthy Volunteers.

The aim of this research is to investigate the effects of ultrasonic noise exposure on the human auditory system (how it effects hearing). Current international regulations concerning ultrasound exposure differs significantly and are based on scarce and outdated scientific data; hence the motivation for this research. A cohort of 20 audiometrically healthy volunteers will undergo pure tone audiometry (PTA); a standard test for hearing sensitivity, at both pre and post exposure to ultrasonic noise (40kHz for 15 min at 120 dB SPL). A subgroup of 10 subjects will be used as a control group. The resulting audiograms will establish the extent of any recoverable loss in hearing sensitivity known as temporary threshold shifts (TTS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult, audiometrically healthy

Exclusion Criteria:

  • Underlying/pre-existing hearing impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control Group
Diagnostic test: Pure Tone Audiometry
Participants will undergo 2 (pre and post exposure) hearing tests
Active Comparator: Noise Exposed Group
Other: Ultrasonic noise exposure
Group will be exposed to 40kHz ultrasonic noise at 110-120 dB SPL for 15 minutes.
Diagnostic test: Pure Tone Audiometry
Participants will undergo 2 (pre and post exposure) hearing tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Temporary Threshold Shifts (TTS)
Time Frame: Audiometry will be conducted immediately (with 2 hours) from noise exposure
Mild and recoverable hearing loss in sensitivity due to noise exposure will be checked for statistical significance using paired and independent t-test.
Audiometry will be conducted immediately (with 2 hours) from noise exposure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ultrahaptics Ltd

Collaborators

Avon Partnership NHS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2018

Primary Completion (Actual)

November 21, 2018

Study Completion (Actual)

November 21, 2018

Study Registration Dates

First Submitted

April 23, 2018

First Submitted That Met QC Criteria

April 23, 2018

First Posted (Actual)

May 4, 2018

Study Record Updates

Last Update Posted (Actual)

December 13, 2018

Last Update Submitted That Met QC Criteria

December 11, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UH-PAN-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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