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NCT03515928 Clinical Trial

The Effects of Ultrasonic Noise Exposure on Human Hearing

Hearing Loss Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03515928
Other study ID # UH-PAN-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 15, 2018
Est. completion date November 21, 2018

Study information
Verified date December 2018
Source Ultrahaptics Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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 Current international regulations concerning ultrasound exposure differs significantly and are based on scarce and outdated scientific data; hence the motivation for this research.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).

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date November 21, 2018
Est. primary completion date November 21, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Adult, audiometrically healthy

Exclusion Criteria:

- Underlying/pre-existing hearing impairment

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United Kingdom Ultrahaptics Bristol

Sponsors (2)
Lead Sponsor Collaborator
Ultrahaptics Ltd NHS Avon Partnership

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Temporary Threshold Shifts (TTS) 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
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