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OpenTrials
Completed

NCT Number: NCT02508220

Short-term Effects of Oxytocin Nasal Spray on Chronic Tinnitus

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

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Key information

Conditions

Chronic Tinnitus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Syntocinon

Drug

Oxytocin nasal spray

Other names: Oxytocin

Placebo

Drug

distilled water in nasal spray

Other names: distilled water

Primary outcomes

  1. Change of tinnitus on VAS

    Time frame: 30 minutes after intervention

  2. Change of Clinical global impression scale

    Time frame: 30 minutes after intervention

Secondary outcomes

  1. Audiometry measured in dB HL

    Time frame: within one hour before intervention

    measured in dB HL

  2. Minimum Masking Level measured in dB HL

    Time frame: within one hour before intervention

    measured in dB HL

  3. Tinnitus Matching

    Time frame: within one hour before intervention

    Frequency measured in Hz

Sponsors and collaborators

Lead sponsor

Berthold Langguth, MD, Ph.D.

Other

Collaborators

  • Otosul -Otorrinolaringologia Sul-Fluminense

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 24, 2015
Registry last updated
Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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