Trial Outcomes & Findings for Nitrous Oxide Treatment for Tinnitus (NCT NCT03365011)
NCT ID: NCT03365011
Last Updated: 2018-12-14
Results Overview
Change of participant-reported tinnitus symptoms 1 week after each intervention. The Tinnitus Functional Index (TFI) is a 25-question survey assessing tinnitus impact on quality of life. Participants were asked to rate on a scale from 0-10 the degree of unpleasantness, cognitive interference, sleep disturbance, auditory difficulties, interference with relaxation, and emotional distress associated with their tinnitus. Subscores are summed and scaled to a score of 0-100. A score less than 25 indicates mild problems due to tinnitus and little need for intervention, while a score between 25-50 indicates significant problems due to tinnitus with potential need for intervention. A decrease in TFI score indicates decreased bother due to tinnitus over time, a better outcome. An increase in TFI score indicates increased bother due to tinnitus over time, a worse outcome.
COMPLETED
PHASE4
40 participants
Pre-intervention and 1 week post-intervention
2018-12-14
Participant Flow
Participant milestones
| Measure |
Placebo First
Participants are randomized to receive placebo during the first session, followed by nitrous oxide during the second session.
|
Nitrous Oxide First
Participants are randomized to receive nitrous oxide during the first session, followed by placebo during the second session.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
19
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Placebo First
Participants are randomized to receive placebo during the first session, followed by nitrous oxide during the second session.
|
Nitrous Oxide First
Participants are randomized to receive nitrous oxide during the first session, followed by placebo during the second session.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
Nitrous Oxide Treatment for Tinnitus
Baseline characteristics by cohort
| Measure |
Placebo First
n=20 Participants
Participants are randomized to receive placebo during the first session, followed by nitrous oxide during the second session.
|
Nitrous Oxide
n=20 Participants
Participants are randomized to receive nitrous oxide during the first session, followed by placebo during the second session.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.5 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
52.8 years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
52.9 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Did not respond
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Tinnitus Functional Index
|
42 units on a scale
n=5 Participants
|
40 units on a scale
n=7 Participants
|
41 units on a scale
n=5 Participants
|
|
Global Bothersome Scale
Not bothered
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Global Bothersome Scale
Bothered a little, but not much
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Global Bothersome Scale
Bothered more than a little, but not a lot
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Global Bothersome Scale
Bothered a lot
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Global Bothersome Scale
Extremely bothered
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-intervention and 1 week post-interventionChange of participant-reported tinnitus symptoms 1 week after each intervention. The Tinnitus Functional Index (TFI) is a 25-question survey assessing tinnitus impact on quality of life. Participants were asked to rate on a scale from 0-10 the degree of unpleasantness, cognitive interference, sleep disturbance, auditory difficulties, interference with relaxation, and emotional distress associated with their tinnitus. Subscores are summed and scaled to a score of 0-100. A score less than 25 indicates mild problems due to tinnitus and little need for intervention, while a score between 25-50 indicates significant problems due to tinnitus with potential need for intervention. A decrease in TFI score indicates decreased bother due to tinnitus over time, a better outcome. An increase in TFI score indicates increased bother due to tinnitus over time, a worse outcome.
Outcome measures
| Measure |
Placebo
n=39 Participants
Placebo was defined as 50% nitrogen and 50% oxygen for 40 minutes.
|
Nitrous Oxide
n=38 Participants
Nitrous oxide treatment was defined as 50% nitrous oxide and 50% oxygen for 40 minutes.
|
|---|---|---|
|
Change in Tinnitus Functional Index (TFI) Score
|
-1.8 score on a scale
Standard Deviation 8.8
|
-2.5 score on a scale
Standard Deviation 11.0
|
SECONDARY outcome
Timeframe: Pre-intervention and 1 week post-interventionChange in participant-reported tinnitus bother after each intervention. Global Bothersome Scale (GBS) measured participant's self-assessment of tinnitus bother on a 5-point scale ranging from "Not bothered, 0" to "Extremely bothered, 5." A change of 0 indicates no change in tinnitus bother over time. A change of -1 indicates somewhat improved tinnitus bother, and a change of positive 1 indicates somewhat worsened tinnitus bother. A change of positive 2 indicates significantly worsened tinnitus bother.
Outcome measures
| Measure |
Placebo
n=39 Participants
Placebo was defined as 50% nitrogen and 50% oxygen for 40 minutes.
|
Nitrous Oxide
n=38 Participants
Nitrous oxide treatment was defined as 50% nitrous oxide and 50% oxygen for 40 minutes.
|
|---|---|---|
|
Change in Global Bothersome Scale (GBS) Score
Somewhat improved, -1
|
5 participants
|
2 participants
|
|
Change in Global Bothersome Scale (GBS) Score
No change, 0
|
28 participants
|
34 participants
|
|
Change in Global Bothersome Scale (GBS) Score
Somewhat worsened, 1
|
5 participants
|
2 participants
|
|
Change in Global Bothersome Scale (GBS) Score
Significantly worsened, 2
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 1 week post-interventionParticipant-reported perception of change in impact of tinnitus on quality of life since receiving each intervention
Outcome measures
| Measure |
Placebo
n=37 Participants
Placebo was defined as 50% nitrogen and 50% oxygen for 40 minutes.
|
Nitrous Oxide
n=37 Participants
Nitrous oxide treatment was defined as 50% nitrous oxide and 50% oxygen for 40 minutes.
|
|---|---|---|
|
Patients' Global Impression of Change
A little better
|
2 Participants
|
2 Participants
|
|
Patients' Global Impression of Change
Somewhat better
|
4 Participants
|
0 Participants
|
|
Patients' Global Impression of Change
Moderately better
|
1 Participants
|
4 Participants
|
|
Patients' Global Impression of Change
Better, definite improvement
|
1 Participants
|
1 Participants
|
|
Patients' Global Impression of Change
No change or worsened
|
24 Participants
|
20 Participants
|
|
Patients' Global Impression of Change
Almost the same
|
5 Participants
|
10 Participants
|
|
Patients' Global Impression of Change
Great deal better, considerable improvement
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo
Nitrous Oxide
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=40 participants at risk
Placebo was defined as 50% nitrogen and 50% oxygen for 40 minutes.
Participants are blinded to the order of interventions administered. Participants have been informed prior to consent that one session will contain the nitrous oxide gas mixture, and the other session will contain the placebo gas mixture.
Placebo gas for inhalation: Placebo gaseous mixture (50% nitrogen and 50% oxygen) for 40 minutes duration under anesthesia supervision with monitoring according to standards set by the American Society of Anesthesiologists.
|
Nitrous Oxide
n=40 participants at risk
Nitrous oxide treatment was defined as 50% nitrous oxide and 50% oxygen for 40 minutes.
Participants are blinded to the order of interventions administered. Participants have been informed prior to consent that one session will contain the nitrous oxide gas mixture, and the other session will contain the placebo gas mixture.
Nitrous oxide gas for inhalation: Nitrous oxide gaseous mixture (50% nitrous oxide and 50% oxygen) for 40 minutes duration under anesthesia supervision with monitoring according to standards set by the American Society of Anesthesiologists.
|
|---|---|---|
|
General disorders
Nausea
|
0.00%
0/40 • 9 months
|
2.5%
1/40 • Number of events 1 • 9 months
|
|
General disorders
Lightheadedness
|
0.00%
0/40 • 9 months
|
2.5%
1/40 • Number of events 1 • 9 months
|
|
General disorders
Panic attack
|
0.00%
0/40 • 9 months
|
2.5%
1/40 • Number of events 1 • 9 months
|
Additional Information
Jay F. Piccirillo, MD, FACS
Washington University School of Medicine in St. Louis
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place