Trial record 12 of 23 for:    Recruiting, Not yet recruiting, Available Studies | "Noise"

The Effects of Ultrasonic Noise Exposure on Human Hearing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03515928
Recruitment Status : Not yet recruiting
First Posted : May 4, 2018
Last Update Posted : October 11, 2018
NHS Avon Partnership
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 Current international regulations concerning ultrasound exposure differs significantly and are based on scarce and outdated scientific data; hence the motivation for this research.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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 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.
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 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

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 identifier (NCT number): NCT03515928

Contact: Andrew DiBattista, Dr +44117 325 9002
Contact: Tom Carter, CTO +44117 325 9002

Sponsors and Collaborators
Ultrahaptics Ltd
NHS Avon Partnership

Responsible Party: Ultrahaptics Ltd Identifier: NCT03515928     History of Changes
Other Study ID Numbers: UH-PAN-001
First Posted: May 4, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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:
Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms