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Short-term Effects of Oxytocin Nasal Spray on Chronic Tinnitus
Plain-language guide to NCT02508220: not phased randomized trial of Oxytocin, tinnitus, 15 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02508220
- Phase
- not phased
- Status
- completed
- Start
- 2015-07
- Completion (planned or actual)
- 2015-11
- Participants
- 15 (actual)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Chronic Tinnitus
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (not phased) is built around Oxytocin for tinnitus.
It had two arms (groups): Oxy-Placebo (other) and Placebo-Oxy (other).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 15 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: 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.
The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: vascular tinnitus; muscular tinnitus; conductive hearing loss.
How the Study Was Run
Design: randomized, crossover and quadruple-blind.
Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.
In the crossover set-up each of the tinnitus participants took both Oxytocin and the comparison in turn, acting as their own control.
Blinding on both sides kept the tinnitus participants and researchers unaware of who received Oxytocin.
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2015-07 with completion listed for 2015-11.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Change of tinnitus on VAS (time frame: 30 minutes after intervention). Change of Clinical global impression scale (time frame: 30 minutes after intervention).
It also tracked 3 secondary outcomes, for example Audiometry measured in dB HL, Minimum Masking Level measured in dB HL and Tinnitus Matching.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Oxytocin in 15 people with tinnitus.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Oxytocin compound page, Tinnitus research.
Our Notes on the Compound
Oxytocin: A peptide hormone with established obstetric medical uses and a less settled role in research on behavior, sexual function and appetite.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.