The Effects of Ultrasonic Noise Exposure on Human Hearing

Sponsor

Ultrahaptics Ltd (Industry)

Overall Status

Completed

CT.gov ID

NCT03515928

Collaborator

Avon Partnership NHS (Other)

Enrollment

Location

Arms

1.2

Actual Duration (Months)

13.2

Patients Per Site Per Month

Study Details

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 Current international regulations concerning ultrasound exposure differs significantly and are based on scarce and outdated scientific data; hence the motivation for this research.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

Condition or Disease	Intervention/Treatment	Phase
Hearing Loss	Other: Ultrasonic noise exposure Diagnostic Test: Pure Tone Audiometry	N/A

Study Design

Study Type:

Interventional

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 :

Oct 15, 2018

Actual Primary Completion Date :

Nov 21, 2018

Actual Study Completion Date :

Nov 21, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Temporary Threshold Shifts (TTS) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Adult, audiometrically healthy

Exclusion Criteria:

Underlying/pre-existing hearing impairment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ultrahaptics	Bristol		United Kingdom	BS2 0EL

Sponsors and Collaborators

Ultrahaptics Ltd
Avon Partnership NHS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ultrahaptics Ltd

ClinicalTrials.gov Identifier:

NCT03515928

Other Study ID Numbers:

UH-PAN-001

First Posted:

May 4, 2018

Last Update Posted:

Dec 13, 2018

Last Verified:

Dec 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ultrahaptics Ltd

Ultrasound, Hearing

Additional relevant MeSH terms:

Hearing Loss

Study Results

No Results Posted as of Dec 13, 2018