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The Effects of Ultrasonic Noise Exposure on Human Hearing

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ClinicalTrials.gov Identifier: NCT03515928
Recruitment Status : Completed
First Posted : May 4, 2018
Last Update Posted : December 13, 2018
Sponsor:
Collaborator:
Avon Partnership NHS
Information provided by (Responsible Party):
Ultrahaptics Ltd

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 Current international regulations concerning ultrasound exposure differs significantly and are based on scarce and outdated scientific data; hence the motivation for this research.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

Condition or disease Intervention/treatment Phase
Hearing Loss Other: Ultrasonic noise exposure Diagnostic Test: Pure Tone Audiometry Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Basic Science
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.
Actual Study Start Date : October 15, 2018
Actual Primary Completion Date : November 21, 2018
Actual Study Completion Date : November 21, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Noise

Arm Intervention/treatment
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

Placebo Comparator: Control Group Diagnostic Test: Pure Tone Audiometry
Participants will undergo 2 (pre and post exposure) hearing tests




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult, audiometrically healthy

Exclusion Criteria:

  • Underlying/pre-existing hearing impairment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515928


Locations
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United Kingdom
Ultrahaptics
Bristol, United Kingdom, BS2 0EL
Sponsors and Collaborators
Ultrahaptics Ltd
Avon Partnership NHS

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Responsible Party: Ultrahaptics Ltd
ClinicalTrials.gov Identifier: NCT03515928     History of Changes
Other Study ID Numbers: UH-PAN-001
First Posted: May 4, 2018    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ultrahaptics Ltd:
Ultrasound, Hearing
Additional relevant MeSH terms:
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Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms