Short-term Effects of Oxytocin Nasal Spray on Chronic Tinnitus

November 30, 2015 updated by: Berthold Langguth, MD, Ph.D.
The study compares the short-term tinnitus reduction following a single oxytocin intervention with a placebo control condition.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Oxy-Placebo
Syntocinon first, Placebo second 2 puffs in each nostril
Drug: Syntocinon
Oxytocin nasal spray
Other Names:
  • Oxytocin
Drug: Placebo
distilled water in nasal spray
Other Names:
  • distilled water
Other: Placebo-Oxy
Placebo first, Syntocinon second 2 puffs in each nostril
Drug: Syntocinon
Oxytocin nasal spray
Other Names:
  • Oxytocin
Drug: Placebo
distilled water in nasal spray
Other Names:
  • distilled water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of tinnitus on VAS
Time Frame: 30 minutes after intervention
30 minutes after intervention
Change of Clinical global impression scale
Time Frame: 30 minutes after intervention
30 minutes after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Audiometry measured in dB HL
Time Frame: within one hour before intervention
measured in dB HL
within one hour before intervention
Minimum Masking Level measured in dB HL
Time Frame: within one hour before intervention
measured in dB HL
within one hour before intervention
Tinnitus Matching
Time Frame: within one hour before intervention
Frequency measured in Hz
within one hour before intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Berthold Langguth, MD, Ph.D.

Collaborators

Otosul -Otorrinolaringologia Sul-Fluminense

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

March 18, 2015

First Submitted That Met QC Criteria

July 23, 2015

First Posted (Estimate)

July 24, 2015

Study Record Updates

Last Update Posted (Estimate)

December 2, 2015

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Uni-Reg-Oxy-Tin

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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