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Short-term Effects of Oxytocin Nasal Spray on Chronic Tinnitus

Not Applicable
Completed
Conditions
Chronic Tinnitus
Interventions
Drug: Placebo
Registration Number
NCT02508220
Lead Sponsor
Berthold Langguth, MD, Ph.D.
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
15
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 & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Oxy-PlaceboPlaceboSyntocinon first, Placebo second 2 puffs in each nostril
Placebo-OxySyntocinonPlacebo first, Syntocinon second 2 puffs in each nostril
Placebo-OxyPlaceboPlacebo first, Syntocinon second 2 puffs in each nostril
Oxy-PlaceboSyntocinonSyntocinon first, Placebo second 2 puffs in each nostril
Primary Outcome Measures
NameTimeMethod
Change of Clinical global impression scale30 minutes after intervention
Change of tinnitus on VAS30 minutes after intervention
Secondary Outcome Measures
NameTimeMethod
Tinnitus Matchingwithin one hour before intervention

Frequency measured in Hz

Minimum Masking Level measured in dB HLwithin one hour before intervention

measured in dB HL

Audiometry measured in dB HLwithin one hour before intervention

measured in dB HL

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