NCT01268449

Brief Summary

The purpose of this study is to determine wether low dose laser is effective on idiopathic subjective tinnitus.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2008

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 30, 2010

Completed
Last Updated

December 30, 2010

Status Verified

August 1, 2010

Enrollment Period

2.4 years

First QC Date

December 29, 2010

Last Update Submit

December 29, 2010

Conditions

Subjective Tinnitus

Keywords

TinnitusLow power laser

Study Arms (2)

Laser group

ACTIVE COMPARATOR
Radiation: Low dose laser

Placebo group

PLACEBO COMPARATOR

Randomly,half of the patients receive placebo.

Radiation: Placebo

Interventions

Low dose laserRADIATION

5mv laser with a wavelength of 650nm

Laser group
PlaceboRADIATION

The act of radiating laser to the ear is done while the set is off.

Placebo group

Eligibility Criteria

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

You may qualify if:

  • Adults older than 18 years old
  • Idiopathic, subjective, unilateral tinnitus with at least 2 month duration

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tinnitus

Interventions

Lasers

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 29, 2010

First Posted

December 30, 2010

Study Start

March 1, 2008

Primary Completion

August 1, 2010

Study Completion

September 1, 2010

Last Updated

December 30, 2010

Record last verified: 2010-08