Subjective TinnitusPhase 2NCT01268449
Evaluation of Low Dose Laser in Treatment of Tinnitus
A Phase 2 study testing Low dose laser in people with Subjective Tinnitus, run by Islamic Azad University of Mashhad.
Trial summary
The purpose of this study is to determine wether low dose laser is effective on idiopathic subjective tinnitus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subjective Tinnitus
- What is being tested?
- Low dose laser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Sep 2010
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults older than 18 years old
- Idiopathic, subjective, unilateral tinnitus with at least 2 month duration
Who cannot join
- Patients with chronic otitis media
- Patients with tympan perforation with any underlying cause
- Patients with external otitis
- Patients with tinnitus related to a retrocochlear lesion or other known lesions of the ear
About this study
Official title: Phase 1 Evaluation of Low Dose Laser in Treatment of Tinnitus
The purpose of this study is to determine wether low dose laser is effective on idiopathic subjective tinnitus.
- Conditions
- Subjective Tinnitus
- Being tested
- Low dose laser, Placebo
- Keywords
- Tinnitus, Low power laser
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose laserRadiation
5mv laser with a wavelength of 650nm
PlaceboRadiation
The act of radiating laser to the ear is done while the set is off.
| Study group | Role | What they receive |
|---|---|---|
| Laser group | Active comparator | Not described Receives: Radiation: Low dose laser |
| Placebo group | Placebo comparator | Randomly,half of the patients receive placebo. Receives: Radiation: Placebo |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2010 (estimated)
- Study startMar 2008
- Primary completionAug 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjective 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Islamic Azad University of Mashhad
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01268449
- Sponsor's protocol ID
- Laser-tinnitus-202
- Status last verified
- Aug 2010
- First submitted
- 29 Dec 2010
- Last updated
- 30 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Evaluation of Low Dose Laser in Treatment of Tinnitus
- ClinicalTrials.gov ID
- NCT01268449
- Acronym / sponsor ID
- Laser-tinnitus-202
- Conditions
- Subjective Tinnitus
- Keywords
- Tinnitus, Low power laser
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Islamic Azad University of MashhadUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 30 Dec 2010 (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 purpose of this study is to determine wether low dose laser is effective on idiopathic subjective tinnitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser group | Active comparator | Radiation: Low dose laser |
| Placebo group | Placebo comparator | Radiation: PlaceboRandomly,half of the patients receive placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults older than 18 years old
- Idiopathic, subjective, unilateral tinnitus with at least 2 month duration
Key exclusion criteria (4 listed)
- Patients with chronic otitis media
- Patients with tympan perforation with any underlying cause
- Patients with external otitis
- Patients with tinnitus related to a retrocochlear lesion or other known lesions of the ear
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 dose laser5mv laser with a wavelength of 650nm | Radiation | Laser group |
| PlaceboThe act of radiating laser to the ear is done while the set is off. | Radiation | Placebo group |
Primary outcome
Not reported in the source record.
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 30 Dec 2010.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low dose laser in people with Subjective Tinnitus, run by Islamic Azad University of Mashhad.
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 4 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 30 Dec 2010. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
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 30 Dec 2010.