Tinnitus
Conditions
Brief summary
The purpose of this study is to evaluate the effects of high-dose intranasal oxytocin for treating tinnitus. The hypothesis is that high dose intranasal oxytocin can significantly reduce tinnitus severity and disability.
Detailed description
This is a pilot, proof of concept, placebo-controlled, parallel study. Participants will be recruited from NYU Langone Medical Center's Ear, Nose & Throat (ENT) Department and will receive either high-dose intranasal oxytocin or a nasal spray containing Pcca Mucolox and distilled water, serving as the placebo. Long term treatment with high-dose oxytocin (45 IU four times daily) may reduce the frequency and severity of tinnitus, the burden tinnitus symptoms cause patients, and improve their quality of life.
Interventions
DRUGOxytocin
The investigational product, oxytocin nasal spray (45 units/0.1mL for 38mL) is composed of: oxytocin powder (0.3080g), magnesium chloride crystals (2.3100g), citric acid anhydrous gran. (0.1080g), sodium citrate powder (2.1500g), sterile water for irrigation (38.000mL), and Pcca Mucolox liquid base (3.8000mL). Subjects will be asked to self-administer the study medication with 1 puff in one nostril 4 times per day
OTHERPlacebo nasal spray
A placebo nasal spray, consisting of magnesium, chloride crystals, citric acid anhydrous gran., sodium citrate powder, sterile water for irrigation, and Pcca Mucolox liquid base. Both active drug and the placebo will appear identical in the glass bottles. The placebo will be administered in the same manner as the active study drug, with 1 puff in one nostril four times per day.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Subjects with continuous perception of subjective tinnitus for ≥ 6 months duration. * Subjects must have had a normal otolaryngologic evaluation within the past year with no evidence of otitis media or externa, a Tinnitus Handicap Inventory (THI) of \> 16. * Subjects must have tinnitus loudness rating of \>4/10.
Exclusion criteria
* Subjects who are being treated for tinnitus \< 6 months due to the acute nature of their condition * Subjects who have a slight handicap according to the Tinnitus Handicap Inventory Severity Scale. * Those with tinnitus of a muscular or vascular etiology * Subjects with conductive hearing loss, history of migraine, or prior use of oxytocin nasal spray. * Women of childbearing age will not be approached for participation due to the risk of oxytocin-induced uterine contractions. * Subjects who suffer from migraines. * Subjects who have history of pulmonary edema, Congestive Heart Failure, and severe renal disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Analogue Scale (VAS)-Rated Tinnitus Loudness | Baseline, Week 9 | Participants use a VAS to rate the loudness of tinnitus on an 11-point Likert scale. Total scores range from 0 (minimum) to 10 (maximum); higher scores indicate greater tinnitus loudness. No response to nasal spray is defined as a decrease in VAS Score of less than 2, while a patient-reported improvement is defined as a decrease in VAS Score of more than 3. |
Countries
United States
Participant flow
Pre-assignment details
The PI and study team has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.
Participants by arm
| Arm | Count |
|---|---|
| High-dose Intranasal Oxytocin Subjects will be asked to use one spray in one nostril 4 times daily (9AM, 1PM, 5PM and 9 PM). Subjects will take 4 sprays daily of oxytocin for the entire study.
Oxytocin: The investigational product, oxytocin nasal spray (45 units/0.1mL for 38mL) is composed of: oxytocin powder (0.3080g), magnesium chloride crystals (2.3100g), citric acid anhydrous gran. (0.1080g), sodium citrate powder (2.1500g), sterile water for irrigation (38.000mL), and Pcca Mucolox liquid base (3.8000mL). Subjects will be asked to self-administer the study medication with 1 puff in one nostril 4 times per day | 32 |
| Nasal Spray Subjects swill be asked to use one spray in one nostril 4 times daily (9AM, 1PM, 5PM and 9 PM). The spray can be taken with or without food. Subjects will take 4 sprays daily of the placebo for the entire study.
Placebo nasal spray: A placebo nasal spray, consisting of magnesium, chloride crystals, citric acid anhydrous gran., sodium citrate powder, sterile water for irrigation, and Pcca Mucolox liquid base. Both active drug and the placebo will appear identical in the glass bottles. The placebo will be administered in the same manner as the active study drug, with 1 puff in one nostril four times per day. | 1 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 32 | 1 |
Baseline characteristics
| Characteristic | Nasal Spray | Total | High-dose Intranasal Oxytocin |
|---|---|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 0 | 60.1 years STANDARD_DEVIATION 11.3 | 59.9 years STANDARD_DEVIATION 11.5 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 1 participants | 33 participants | 32 participants |
| Sex: Female, Male Female | 0 Participants | 5 Participants | 5 Participants |
| Sex: Female, Male Male | 1 Participants | 28 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 1 |
| other Total, other adverse events | 6 / 32 | 0 / 1 |
| serious Total, serious adverse events | 1 / 32 | 0 / 1 |
Outcome results
Primary
Change in Visual Analogue Scale (VAS)-Rated Tinnitus Loudness
Participants use a VAS to rate the loudness of tinnitus on an 11-point Likert scale. Total scores range from 0 (minimum) to 10 (maximum); higher scores indicate greater tinnitus loudness. No response to nasal spray is defined as a decrease in VAS Score of less than 2, while a patient-reported improvement is defined as a decrease in VAS Score of more than 3.
Time frame: Baseline, Week 9
Population: Study was terminated prematurely due to PI and study team departing the institution. Data were not collected for the primary outcome measure.