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Short-term Effects of Oxytocin Nasal Spray on Chronic Tinnitus

Primary Purpose

Chronic Tinnitus

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Syntocinon
Placebo
Sponsored by
Berthold Langguth, MD, Ph.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Tinnitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • chronic tinnitus with a duration > 6 months
  • medical examination by an ENT specialist
  • sufficient knowledge of the Portuguese language to follow the instructions and answer the questionnaires
  • VAS score >4 points

Exclusion Criteria:

  • vascular tinnitus
  • muscular tinnitus
  • conductive hearing loss
  • previous experience with oxytocin nasal spray
  • additional medications during the intervention

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Oxy-Placebo

    Placebo-Oxy

    Arm Description

    Syntocinon first, Placebo second 2 puffs in each nostril

    Placebo first, Syntocinon second 2 puffs in each nostril

    Outcomes

    Primary Outcome Measures

    Change of tinnitus on VAS
    Change of Clinical global impression scale

    Secondary Outcome Measures

    Audiometry measured in dB HL
    measured in dB HL
    Minimum Masking Level measured in dB HL
    measured in dB HL
    Tinnitus Matching
    Frequency measured in Hz

    Full Information

    First Posted
    March 18, 2015
    Last Updated
    November 30, 2015
    Sponsor
    Berthold Langguth, MD, Ph.D.
    Collaborators
    Otosul -Otorrinolaringologia Sul-Fluminense
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02508220
    Brief Title
    Short-term Effects of Oxytocin Nasal Spray on Chronic Tinnitus
    Official Title
    Short-term Effects of Oxytocin Nasal Spray on Chronic Tinnitus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2015 (undefined)
    Primary Completion Date
    November 2015 (Actual)
    Study Completion Date
    November 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Berthold Langguth, MD, Ph.D.
    Collaborators
    Otosul -Otorrinolaringologia Sul-Fluminense

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study compares the short-term tinnitus reduction following a single oxytocin intervention with a placebo control condition.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    15 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Oxy-Placebo
    Arm Type
    Other
    Arm Description
    Syntocinon first, Placebo second 2 puffs in each nostril
    Arm Title
    Placebo-Oxy
    Arm Type
    Other
    Arm Description
    Placebo first, Syntocinon second 2 puffs in each nostril
    Intervention Type
    Drug
    Intervention Name(s)
    Syntocinon
    Other Intervention Name(s)
    Oxytocin
    Intervention Description
    Oxytocin nasal spray
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    distilled water
    Intervention Description
    distilled water in nasal spray
    Primary Outcome Measure Information:
    Title
    Change of tinnitus on VAS
    Time Frame
    30 minutes after intervention
    Title
    Change of Clinical global impression scale
    Time Frame
    30 minutes after intervention
    Secondary Outcome Measure Information:
    Title
    Audiometry measured in dB HL
    Description
    measured in dB HL
    Time Frame
    within one hour before intervention
    Title
    Minimum Masking Level measured in dB HL
    Description
    measured in dB HL
    Time Frame
    within one hour before intervention
    Title
    Tinnitus Matching
    Description
    Frequency measured in Hz
    Time Frame
    within one hour before intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: chronic tinnitus with a duration > 6 months medical examination by an ENT specialist sufficient knowledge of the Portuguese language to follow the instructions and answer the questionnaires VAS score >4 points Exclusion Criteria: vascular tinnitus muscular tinnitus conductive hearing loss previous experience with oxytocin nasal spray additional medications during the intervention

    12. IPD Sharing Statement

    Learn more about this trial

    Short-term Effects of Oxytocin Nasal Spray on Chronic Tinnitus

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