Short-term Effects of Oxytocin Nasal Spray on Chronic Tinnitus

NCT ID: NCT02508220

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2015-11-30

Brief Summary

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

Detailed Description

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Conditions

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Chronic Tinnitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Oxy-Placebo

Syntocinon first, Placebo second 2 puffs in each nostril

Group Type OTHER

Syntocinon

Intervention Type DRUG

Oxytocin nasal spray

Placebo

Intervention Type DRUG

distilled water in nasal spray

Placebo-Oxy

Placebo first, Syntocinon second 2 puffs in each nostril

Group Type OTHER

Syntocinon

Intervention Type DRUG

Oxytocin nasal spray

Placebo

Intervention Type DRUG

distilled water in nasal spray

Interventions

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Syntocinon

Oxytocin nasal spray

Intervention Type DRUG

Placebo

distilled water in nasal spray

Intervention Type DRUG

Other Intervention Names

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Oxytocin distilled water

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otosul -Otorrinolaringologia Sul-Fluminense

UNKNOWN

Sponsor Role collaborator

Berthold Langguth, MD, Ph.D.

OTHER

Sponsor Role lead

Responsible Party

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Berthold Langguth, MD, Ph.D.

Chair of the Tinnitus centrum Regensburg

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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Uni-Reg-Oxy-Tin

Identifier Type: -

Identifier Source: org_study_id