TinnitusNCT04962750
Low Level Laser Therapy for Treatment of Tinnitus in Red Sea Scuba Divers
A study testing Low level laser therapy in people with Tinnitus, run by Egyptian Biomedical Research Network.
Trial summary
Scuba Diving has become a popular hobby, for a leisure activity, diving puts the auditory system at the risk of a wide variety of complaints including tinnitus, Low level laser therapy is a new modality in treatment of tinnitus. This study evaluates effect of laser therapy on tinnitus of Scuba divers in Red Sea. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- Low level laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Dec 2020
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- scuba divers
Who cannot join
- Other ear or neurological diseases
About this study
Official title: Low Level Laser Therapy for Treatment of Tinnitus in Red Sea Scuba Divers: A Randomized Clinical Study
Scuba Diving has become a popular hobby, for a leisure activity, diving puts the auditory system at the risk of a wide variety of complaints including tinnitus, Low level laser therapy is a new modality in treatment of tinnitus. This study evaluates effect of laser therapy on tinnitus of Scuba divers in Red Sea.
- Conditions
- Tinnitus
- Being tested
- Low level laser therapy, Sham device
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low level laser therapyDevice
Low level laser therapy from suitable machine
Sham deviceOther
The device wasn't working
| Study group | Role | What they receive |
|---|---|---|
| laser therapy | Experimental | Not described Receives: Device: Low level laser therapy |
| Control | Sham comparator | Not described Receives: Other: Sham device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus Questionnaire score
A score that evaluates level of tinnitus
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start1 Jan 2017
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egyptian Biomedical Research Network
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Osama El-sayyad, Principal investigator, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962750
- Sponsor's protocol ID
- N13476
- Status last verified
- Jul 2021
- First submitted
- 3 Jul 2021
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Level Laser Therapy for Treatment of Tinnitus in Red Sea Scuba Divers: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT04962750
- Acronym / sponsor ID
- N13476
- Conditions
- Tinnitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Egyptian Biomedical Research NetworkResearch network
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 15 Jul 2021 (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.
Scuba Diving has become a popular hobby, for a leisure activity, diving puts the auditory system at the risk of a wide variety of complaints including tinnitus, Low level laser therapy is a new modality in treatment of tinnitus. This study evaluates effect of laser therapy on tinnitus of Scuba divers in Red Sea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laser therapy | Experimental | Device: Low level laser therapy |
| Control | Sham comparator | Other: Sham device |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- scuba divers
Key exclusion criteria (1 listed)
- Other ear or neurological diseases
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 |
|---|---|---|
| Low level laser therapyLow level laser therapy from suitable machine | Device | laser therapy |
| Sham deviceThe device wasn't working | Other | Control |
Primary outcome
Tinnitus Questionnaire score
Time frame: 20 days
A score that evaluates level of tinnitus
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 15 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Osama El-sayyad principal investigator
Benha University
Questions about this trial
What is this clinical trial studying?
A study testing Low level laser therapy in people with Tinnitus, run by Egyptian Biomedical Research Network.
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 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Tinnitus Questionnaire score (time frame: 20 days). 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 15 Jul 2021.