Hearing LossNCT03515928
The Effects of Ultrasonic Noise Exposure on Human Hearing
A study testing Ultrasonic noise exposure and Pure Tone Audiometry in people with Hearing Loss, run by Ultrahaptics Ltd at 1 site in United Kingdom.
Trial 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 Current international regulations concerning ultrasound exposure differs significantly and are based on scarce and outdated scientific data; hence the motivation for this research. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Ultrasonic noise exposure and Pure Tone Audiometry
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Oct 2018to 21 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult, audiometrically healthy
Who cannot join
- Underlying/pre-existing hearing impairment
Trial locations and contacts
1 site in 1 country.
About this study
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.
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 Current international regulations concerning ultrasound exposure differs significantly and are based on scarce and outdated scientific data; hence the motivation for this research.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).
- Conditions
- Hearing Loss
- Being tested
- Ultrasonic noise exposure, Pure Tone Audiometry
- Keywords
- Ultrasound, Hearing
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonic noise exposureOther
Group will be exposed to 40kHz ultrasonic noise at 110-120 dB SPL for 15 minutes.
Pure Tone AudiometryDiagnostic test
Participants will undergo 2 (pre and post exposure) hearing tests
| Study group | Role | What they receive |
|---|---|---|
| Noise Exposed Group | Active comparator | Not described Receives: Other: Ultrasonic noise exposure; Diagnostic Test: Pure Tone Audiometry |
| Control Group | Placebo comparator | Not described Receives: Diagnostic Test: Pure Tone Audiometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Audiometry will be conducted immediately (with 2 hours) from noise exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start15 Oct 2018
- Primary completion21 Nov 2018
- Study completion21 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ultrahaptics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avon Partnership NHS
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03515928
- Sponsor's protocol ID
- UH-PAN-001
- Status last verified
- Dec 2018
- First submitted
- 23 Apr 2018
- Last updated
- 13 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03515928
- Acronym / sponsor ID
- UH-PAN-001
- Conditions
- Hearing Loss
- Keywords
- Ultrasound, Hearing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Ultrahaptics LtdIndustry (pharma, biotech, devices)
- Collaborators
- Avon Partnership NHS
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 21 Nov 2018 (actual)
- Study completion
- 21 Nov 2018 (actual)
- First posted
- 4 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Noise Exposed Group | Active comparator | Other: Ultrasonic noise exposure, Diagnostic Test: Pure Tone Audiometry |
| Control Group | Placebo comparator | Diagnostic Test: Pure Tone Audiometry |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult, audiometrically healthy
Key exclusion criteria (1 listed)
- Underlying/pre-existing hearing impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasonic noise exposureGroup will be exposed to 40kHz ultrasonic noise at 110-120 dB SPL for 15 minutes. | Other | Noise Exposed Group |
| Pure Tone AudiometryParticipants will undergo 2 (pre and post exposure) hearing tests | Diagnostic test | Control Group, Noise Exposed Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonic noise exposure and Pure Tone Audiometry in people with Hearing Loss, run by Ultrahaptics Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temporary Threshold Shifts (TTS) (time frame: Audiometry will be conducted immediately (with 2 hours) from noise exposure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2018.