Noise-induced TinnitusNCT01727492
Prevention of Noise-induced Damage by Use of Antioxidants
A study testing Antioxidantia in people with Noise-induced Tinnitus and Noise-induced Hearing Loss, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
The current study is a dubble-blinde placebo-controlled cross-over study verifying the preventive effect of antioxidants on noise-induced hearing loss (NIHL) and noise-induced tinnitus (NIT). Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Noise-induced Tinnitus, Noise-induced Hearing Loss
- What is being tested?
- Antioxidantia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2012to not given
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18-25 years old
- Temporary tinnitus after noise exposure: loudness >5 on a VAS
Who cannot join
- middle ear problems
- Allergy for magnesium or n-acetylcystein
- Use of hearing protection when going out
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Antwerp University Hospital
Antwerp, Edegem, 2650
Annick Gilles, Master, 32 821 32 57, annick.gilles@uza.be
Annick Gilles, Master
About this study
The current study is a dubble-blinde placebo-controlled cross-over study verifying the preventive effect of antioxidants on noise-induced hearing loss (NIHL) and noise-induced tinnitus (NIT). The antioxidants comprise of a mixture of magnesium and n-acetylcystein which should be taken 1h before leisure noise above 100dB for at least 30 minutes.
- Conditions
- Noise-induced Tinnitus, Noise-induced Hearing Loss
- Being tested
- Antioxidantia
- Keywords
- prevention, noise-induced tinnitus, noise-induced hearing loss, young population
- Medical subject headings
- Tinnitus, Hearing Loss, Noise-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntioxidantiaDrug
| Study group | Role | What they receive |
|---|---|---|
| sugar pill | Placebo comparator | Not described |
| Antioxidantia | Active comparator | Dosage: 600mg n-acetylcystein and 200mg magnesium intake: 1 hour before leisure noise exposure above 100dB of at least 30 minutes frequency: 4 separate events (2x placebo, 2x antioxidants) Receives: Drug: Antioxidantia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protection against noise-induced tinnitus due to antioxidants
Antioxidants protect against temporary threshold shift. The most prevalent cause of noise-induced tinnitus is noise-induced hearing loss. Therefore, it is assumed that the preventive intake of antioxidants prior to a loud event, might protect against threshold shift as well as noise-induced tinnitus.
A 50% decrease of tinnitus loudness scored on a Visual Analogue Scale (VAS) compared to placebo trials is expected.
Secondary outcomes (1)
Change of tinnitus duration
It is expected that with the intake of antioxidants noise-induced tinnitus is prevented or reduced after loud music exposure. In addition, it is expected that the tinnitus persistence is shortened compared to the placebo arm.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2012 (estimated)
- Study startNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Noise-induced TinnitusStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ethisch Comité UZ Antwerpen, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01727492
- Sponsor's protocol ID
- 12/18/172
- Status last verified
- Nov 2013
- First submitted
- 28 Sep 2012
- Last updated
- 6 Nov 2013
- Results posted
- No
Publications
Gilles A, Ihtijarevic B, Wouters K, Van de Heyning P. Using prophylactic antioxidants to prevent noise-induced hearing damage in young adults: a protocol for a double-blind, randomized controlled trial. Trials. 2014 Apr 5;15:110. doi: 10.1186/1745-6215-15-110.
PubMed 24708640
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Noise-induced Damage by Use of Antioxidants
- ClinicalTrials.gov ID
- NCT01727492
- Acronym / sponsor ID
- 12/18/172
- Conditions
- Noise-induced Tinnitus, Noise-induced Hearing Loss
- Keywords
- prevention, noise-induced tinnitus, noise-induced hearing loss, young population
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- Nov 2012
- First posted
- 16 Nov 2012 (estimated)
- 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 current study is a dubble-blinde placebo-controlled cross-over study verifying the preventive effect of antioxidants on noise-induced hearing loss (NIHL) and noise-induced tinnitus (NIT). The antioxidants comprise of a mixture of magnesium and n-acetylcystein which should be taken 1h before leisure noise above 100dB for at least 30 minutes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sugar pill | Placebo comparator | – |
| Antioxidantia | Active comparator | Drug: AntioxidantiaDosage: 600mg n-acetylcystein and 200mg magnesium intake: 1 hour before leisure noise exposure above 100dB of at least 30 minutes frequency: 4 separate events (2x placebo, 2x antioxidants) |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age: 18-25 years old
- Temporary tinnitus after noise exposure: loudness >5 on a VAS
Key exclusion criteria (3 listed)
- middle ear problems
- Allergy for magnesium or n-acetylcystein
- Use of hearing protection when going out
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 |
|---|---|---|
| Antioxidantia | Drug | Antioxidantia |
Primary outcome
Protection against noise-induced tinnitus due to antioxidants
Antioxidants protect against temporary threshold shift. The most prevalent cause of noise-induced tinnitus is noise-induced hearing loss. Therefore, it is assumed that the preventive intake of antioxidants prior to a loud event, might protect against threshold shift as well as noise-induced tinnitus. A 50% decrease of tinnitus loudness scored on a Visual Analogue Scale (VAS) compared to placebo trials is expected.
1 secondary outcome
Change of tinnitus duration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2013.
- Derived from this study: PubMed 24708640Gilles A, Ihtijarevic B, Wouters K, Van de Heyning P. Using prophylactic antioxidants to prevent noise-induced hearing damage in young adults: a protocol for a double-blind, randomized controlled trial. Trials. 2014 Apr 5;15:110. doi: 10.1186/1745-6215-15-110.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antioxidantia in people with Noise-induced Tinnitus and Noise-induced Hearing Loss, run by University Hospital, Antwerp at 1 site in Belgium.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 6 Nov 2013. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annick Gilles, Master (32 3 821 52 80, annick.gilles@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protection against noise-induced tinnitus due to antioxidants. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01727492, which also lists 1 linked publication.
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 6 Nov 2013.