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The Effects of Ultrasonic Noise Exposure on Human Hearing

Primary Purpose

Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Ultrasonic noise exposure
Pure Tone Audiometry
Sponsored by
Ultrahaptics Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hearing Loss focused on measuring Ultrasound, Hearing

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adult, audiometrically healthy

Exclusion Criteria:

  • Underlying/pre-existing hearing impairment

Sites / Locations

  • Ultrahaptics

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Noise Exposed Group

Control Group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 23, 2018
Last Updated
December 11, 2018
Sponsor
Ultrahaptics Ltd
Collaborators
Avon Partnership NHS
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1. Study Identification

Unique Protocol Identification Number
NCT03515928
Brief Title
The Effects of Ultrasonic Noise Exposure on Human Hearing
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
November 21, 2018 (Actual)
Study Completion Date
November 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ultrahaptics Ltd
Collaborators
Avon Partnership NHS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
Ultrasound, Hearing

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Noise Exposed Group
Arm Type
Active Comparator
Arm Title
Control Group
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Ultrasonic noise exposure
Intervention Description
Group will be exposed to 40kHz ultrasonic noise at 110-120 dB SPL for 15 minutes.
Intervention Type
Diagnostic Test
Intervention Name(s)
Pure Tone Audiometry
Intervention Description
Participants will undergo 2 (pre and post exposure) hearing tests
Primary Outcome Measure Information:
Title
Temporary Threshold Shifts (TTS)
Description
Mild and recoverable hearing loss in sensitivity due to noise exposure will be checked for statistical significance using paired and independent t-test.
Time Frame
Audiometry will be conducted immediately (with 2 hours) from noise exposure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult, audiometrically healthy Exclusion Criteria: Underlying/pre-existing hearing impairment
Facility Information:
Facility Name
Ultrahaptics
City
Bristol
ZIP/Postal Code
BS2 0EL
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Effects of Ultrasonic Noise Exposure on Human Hearing

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