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Completed

NCT Number: NCT03515928

The Effects of Ultrasonic Noise Exposure on Human Hearing

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 Current international regulations concerning ultrasound exposure differs significantly and are based on scarce and outdated scientific data; hence the motivation for this research.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

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Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ultrahaptics

Bristol, BS2 0EL, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult, audiometrically healthy

Exclusion criteria

  • Underlying/pre-existing hearing impairment

Treatment and study plan

Ultrasonic noise exposure

Other

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

Pure Tone Audiometry

Diagnostic Test

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Ultrahaptics Ltd

Industry

Collaborators

  • Avon Partnership NHS

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 4, 2018
Registry last updated
Dec 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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