Short-term Effects of Oxytocin Nasal Spray on Chronic Tinnitus

Chronic Tinnitus Clinical Trial

Official title:

Short-term Effects of Oxytocin Nasal Spray on Chronic Tinnitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02508220
• Other study ID #: Uni-Reg-Oxy-Tin
• Status: Completed
• Phase: N/A
• First received: March 18, 2015
• Last updated: November 30, 2015
• Start date: July 2015
• Est. completion date: November 2015

Study information

• Verified date: July 2015
• Source: University of Regensburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Tinnitus
• Tinnitus

Intervention

Drug:
• Syntocinon
Oxytocin nasal spray
• Placebo
distilled water in nasal spray

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Berthold Langguth, MD, Ph.D.	Otosul -Otorrinolaringologia Sul-Fluminense

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of tinnitus on VAS		30 minutes after intervention	No
Primary	Change of Clinical global impression scale		30 minutes after intervention	No
Secondary	Audiometry measured in dB HL	measured in dB HL	within one hour before intervention	No
Secondary	Minimum Masking Level measured in dB HL	measured in dB HL	within one hour before intervention	No
Secondary	Tinnitus Matching	Frequency measured in Hz	within one hour before intervention	No