NCT02508220

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 24, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

December 2, 2015

Status Verified

July 1, 2015

Enrollment Period

4 months

First QC Date

March 18, 2015

Last Update Submit

November 30, 2015

Conditions

Chronic Tinnitus

Outcome Measures

Primary Outcomes (2)

  • Change of tinnitus on VAS

    30 minutes after intervention

  • Change of Clinical global impression scale

    30 minutes after intervention

Secondary Outcomes (3)

  • Audiometry measured in dB HL

    within one hour before intervention

  • Minimum Masking Level measured in dB HL

    within one hour before intervention

  • Tinnitus Matching

    within one hour before intervention

Study Arms (2)

Oxy-Placebo

OTHER

Syntocinon first, Placebo second 2 puffs in each nostril

Drug: SyntocinonDrug: Placebo

Placebo-Oxy

OTHER

Placebo first, Syntocinon second 2 puffs in each nostril

Drug: SyntocinonDrug: Placebo

Interventions

SyntocinonDRUG

Oxytocin nasal spray

Also known as: Oxytocin
Oxy-PlaceboPlacebo-Oxy
PlaceboDRUG

distilled water in nasal spray

Also known as: distilled water
Oxy-PlaceboPlacebo-Oxy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • vascular tinnitus
  • muscular tinnitus
  • conductive hearing loss
  • previous experience with oxytocin nasal spray
  • additional medications during the intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chair of the Tinnitus centrum Regensburg

Study Record Dates

First Submitted

March 18, 2015

First Posted

July 24, 2015

Study Start

July 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

December 2, 2015

Record last verified: 2015-07