Chronic TinnitusNCT02508220
Short-term Effects of Oxytocin Nasal Spray on Chronic Tinnitus
A study testing Syntocinon in people with Chronic Tinnitus, run by Berthold Langguth, MD, Ph.D..
Trial summary
The study compares the short-term tinnitus reduction following a single oxytocin intervention with a placebo control condition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Tinnitus
- What is being tested?
- Syntocinon
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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
Who cannot join
- vascular tinnitus
- muscular tinnitus
- conductive hearing loss
- previous experience with oxytocin nasal spray
- additional medications during the intervention
About this study
The study compares the short-term tinnitus reduction following a single oxytocin intervention with a placebo control condition.
- Conditions
- Chronic Tinnitus
- Being tested
- Syntocinon, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SyntocinonDrug
Also called Oxytocin
Oxytocin nasal spray
PlaceboDrug
Also called distilled water
distilled water in nasal spray
| Study group | Role | What they receive |
|---|---|---|
| Oxy-Placebo | Other | Syntocinon first, Placebo second 2 puffs in each nostril Receives: Drug: Syntocinon; Drug: Placebo |
| Placebo-Oxy | Other | Placebo first, Syntocinon second 2 puffs in each nostril Receives: Drug: Syntocinon; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of tinnitus on VAS
Measured: 30 minutes after intervention
Change of Clinical global impression scale
Measured: 30 minutes after intervention
Secondary outcomes (3)
Audiometry measured in dB HL
measured in dB HL
Measured: within one hour before intervention
Minimum Masking Level measured in dB HL
measured in dB HL
Measured: within one hour before intervention
Tinnitus Matching
Frequency measured in Hz
Measured: within one hour before intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Berthold Langguth, MD, Ph.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Otosul -Otorrinolaringologia Sul-Fluminense
- Responsible party
- Sponsor-investigator, Berthold Langguth, MD, Ph.D., University of Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02508220
- Sponsor's protocol ID
- Uni-Reg-Oxy-Tin
- Status last verified
- Jul 2015
- First submitted
- 18 Mar 2015
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effects of Oxytocin Nasal Spray on Chronic Tinnitus
- ClinicalTrials.gov ID
- NCT02508220
- Acronym / sponsor ID
- Uni-Reg-Oxy-Tin
- Conditions
- Chronic Tinnitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Berthold Langguth, MD, Ph.D.University, hospital or other
- Collaborators
- Otosul -Otorrinolaringologia Sul-Fluminense
- Study start
- Jul 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 24 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study compares the short-term tinnitus reduction following a single oxytocin intervention with a placebo control condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxy-Placebo | Other | Drug: Syntocinon, Drug: PlaceboSyntocinon first, Placebo second 2 puffs in each nostril |
| Placebo-Oxy | Other | Drug: Syntocinon, Drug: PlaceboPlacebo first, Syntocinon second 2 puffs in each nostril |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- vascular tinnitus
- muscular tinnitus
- conductive hearing loss
- previous experience with oxytocin nasal spray
- additional medications during the intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SyntocinonAlso: OxytocinOxytocin nasal spray | Drug | Oxy-Placebo, Placebo-Oxy |
| PlaceboAlso: distilled waterdistilled water in nasal spray | Drug | Oxy-Placebo, Placebo-Oxy |
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
3 secondary outcomes
Audiometry measured in dB HL
Time frame: within one hour before intervention
Minimum Masking Level measured in dB HL
Time frame: within one hour before intervention
Tinnitus Matching
Time frame: within one hour before intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
Related trials for Chronic Tinnitus
Not yet recruitingPhase 1/2
Acute Nicotine Gum and Auditory Brain Responses in Adults With Chronic Tinnitus
Tinnitus, Chronic Subjective Tinnitus
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruitingPhase 1/2
A Study Testing Safety and Efficacy of Transtympanic Paliroden for the Treatment of Cochlear Synaptopathy in Participants With Chronic, Constant Tinnitus
Tinnitus, Bilateral, Cochlear Synaptopathy
Not yet recruitingPhase 4
Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
Not yet recruiting
Efficacy Analysis of Transcutaneous Auricular Vagus Nerve Stimulation Combined With Tailor-Made Notched Music Therapy in the Treatment of Chronic Subjective Tinnitus
Chronic Subjective Tinnitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Syntocinon in people with Chronic Tinnitus, run by Berthold Langguth, MD, Ph.D..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of tinnitus on VAS (time frame: 30 minutes after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.