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Low Level Laser Therapy for Treatment of Tinnitus in Red Sea Scuba Divers

Primary Purpose

Tinnitus

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low level laser therapy
Sham device
Sponsored by
Egyptian Biomedical Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- scuba divers

Exclusion Criteria:

  • Other ear or neurological diseases

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    laser therapy

    Control

    Arm Description

    Outcomes

    Primary Outcome Measures

    Tinnitus Questionnaire score
    A score that evaluates level of tinnitus

    Secondary Outcome Measures

    Full Information

    First Posted
    July 3, 2021
    Last Updated
    July 3, 2021
    Sponsor
    Egyptian Biomedical Research Network
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04962750
    Brief Title
    Low Level Laser Therapy for Treatment of Tinnitus in Red Sea Scuba Divers
    Official Title
    Low Level Laser Therapy for Treatment of Tinnitus in Red Sea Scuba Divers: A Randomized Clinical Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2017 (Actual)
    Primary Completion Date
    December 31, 2020 (Actual)
    Study Completion Date
    December 31, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Egyptian Biomedical Research Network

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tinnitus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    200 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    laser therapy
    Arm Type
    Experimental
    Arm Title
    Control
    Arm Type
    Sham Comparator
    Intervention Type
    Device
    Intervention Name(s)
    Low level laser therapy
    Intervention Description
    Low level laser therapy from suitable machine
    Intervention Type
    Other
    Intervention Name(s)
    Sham device
    Intervention Description
    The device wasn't working
    Primary Outcome Measure Information:
    Title
    Tinnitus Questionnaire score
    Description
    A score that evaluates level of tinnitus
    Time Frame
    20 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - scuba divers Exclusion Criteria: Other ear or neurological diseases
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Osama El-sayyad
    Organizational Affiliation
    Benha University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Low Level Laser Therapy for Treatment of Tinnitus in Red Sea Scuba Divers

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