NCT03515928

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 Current international regulations concerning ultrasound exposure differs significantly and are based on scarce and outdated scientific data; hence the motivation for this research.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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 4, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

October 15, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2018

Completed
Last Updated

December 13, 2018

Status Verified

December 1, 2018

Enrollment Period

1 month

First QC Date

April 23, 2018

Last Update Submit

December 11, 2018

Conditions

Hearing Loss

Keywords

Ultrasound, Hearing

Outcome Measures

Primary Outcomes (1)

  • Temporary Threshold Shifts (TTS)

    Mild and recoverable hearing loss in sensitivity due to noise exposure will be checked for statistical significance using paired and independent t-test.

    Audiometry will be conducted immediately (with 2 hours) from noise exposure

Study Arms (2)

Noise Exposed Group

ACTIVE COMPARATOR
Other: Ultrasonic noise exposureDiagnostic Test: Pure Tone Audiometry

Control Group

PLACEBO COMPARATOR
Diagnostic Test: Pure Tone Audiometry

Interventions

Ultrasonic noise exposureOTHER

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

Noise Exposed Group
Pure Tone AudiometryDIAGNOSTIC_TEST

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

Control GroupNoise Exposed Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult, audiometrically healthy

You may not qualify if:

  • Underlying/pre-existing hearing impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ultrahaptics

Bristol, BS2 0EL, United Kingdom

Location

MeSH Terms

Conditions

Hearing Loss

Interventions

Audiometry, Pure-Tone

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AudiometryHearing TestsDiagnostic Techniques, OtologicalDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2018

First Posted

May 4, 2018

Study Start

October 15, 2018

Primary Completion

November 21, 2018

Study Completion

November 21, 2018

Last Updated

December 13, 2018

Record last verified: 2018-12

Locations

GB(1)