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The Effects of Ultrasonic Noise Exposure on Human Hearing

NCT ID: NCT03515928

Last Updated: 2018-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-15

Study Completion Date

2018-11-21

Brief Summary

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 Current international regulations concerning ultrasound exposure differs significantly and are based on scarce and outdated scientific data; hence the motivation for this research.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

Detailed Description

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Conditions

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Hearing Loss

Keywords

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Ultrasound, Hearing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Noise Exposed Group

Group Type ACTIVE_COMPARATOR

Ultrasonic noise exposure

Intervention Type OTHER

Group will be exposed to 40kHz ultrasonic noise at 110-120 dB SPL for 15 minutes.

Pure Tone Audiometry

Intervention Type DIAGNOSTIC_TEST

Participants will undergo 2 (pre and post exposure) hearing tests

Control Group

Group Type PLACEBO_COMPARATOR

Pure Tone Audiometry

Intervention Type DIAGNOSTIC_TEST

Participants will undergo 2 (pre and post exposure) hearing tests

Interventions

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Ultrasonic noise exposure

Group will be exposed to 40kHz ultrasonic noise at 110-120 dB SPL for 15 minutes.

Intervention Type OTHER

Pure Tone Audiometry

Participants will undergo 2 (pre and post exposure) hearing tests

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Adult, audiometrically healthy

Exclusion Criteria

* Underlying/pre-existing hearing impairment
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Avon Partnership NHS

OTHER

Sponsor Role collaborator

Ultrahaptics Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ultrahaptics

Bristol, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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UH-PAN-001

Identifier Type: -

Identifier Source: org_study_id