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Nitrous Oxide Treatment for Tinnitus

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ClinicalTrials.gov Identifier: NCT03365011
Recruitment Status : Completed
First Posted : December 7, 2017
Results First Posted : November 6, 2018
Last Update Posted : December 14, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Tinnitus
Interventions Drug: Nitrous oxide gas for inhalation
Drug: Placebo gas for inhalation
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo First Nitrous Oxide First
Hide Arm/Group Description Participants are randomized to receive placebo during the first session, followed by nitrous oxide during the second session. Participants are randomized to receive nitrous oxide during the first session, followed by placebo during the second session.
Period Title: Overall Study
Started 20 20
Completed 19 18
Not Completed 1 2
Reason Not Completed
Withdrawal by Subject             1             2
Arm/Group Title Placebo First Nitrous Oxide Total
Hide Arm/Group Description Participants are randomized to receive placebo during the first session, followed by nitrous oxide during the second session. Participants are randomized to receive nitrous oxide during the first session, followed by placebo during the second session. Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
53.5  (9.4) 52.8  (11.1) 52.9  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
13
  65.0%
7
  35.0%
20
  50.0%
Male
7
  35.0%
13
  65.0%
20
  50.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 20 participants 20 participants 40 participants
White
16
  80.0%
15
  75.0%
31
  77.5%
Black
1
   5.0%
2
  10.0%
3
   7.5%
Other
3
  15.0%
2
  10.0%
5
  12.5%
Did not respond
0
   0.0%
1
   5.0%
1
   2.5%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 20 participants 20 participants 40 participants
20
 100.0%
20
 100.0%
40
 100.0%
Tinnitus Functional Index   [1] 
Median (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 20 participants 20 participants 40 participants
42
(6 to 82)
40
(21 to 92)
41
(6 to 92)
[1]
Measure Description: 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.
Global Bothersome Scale  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Not bothered
0
   0.0%
0
   0.0%
0
   0.0%
Bothered a little, but not much
0
   0.0%
0
   0.0%
0
   0.0%
Bothered more than a little, but not a lot
12
  60.0%
12
  60.0%
24
  60.0%
Bothered a lot
7
  35.0%
5
  25.0%
12
  30.0%
Extremely bothered
1
   5.0%
3
  15.0%
4
  10.0%
1.Primary Outcome
Title Change in Tinnitus Functional Index (TFI) Score
Hide Description

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.

Time Frame Pre-intervention and 1 week post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Nitrous Oxide
Hide Arm/Group Description:
Placebo was defined as 50% nitrogen and 50% oxygen for 40 minutes.
Nitrous oxide treatment was defined as 50% nitrous oxide and 50% oxygen for 40 minutes.
Overall Number of Participants Analyzed 39 38
Mean (Standard Deviation)
Unit of Measure: score on a scale
-1.8  (8.8) -2.5  (11.0)
2.Secondary Outcome
Title Change in Global Bothersome Scale (GBS) Score
Hide Description

Change 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.

Time Frame Pre-intervention and 1 week post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Nitrous Oxide
Hide Arm/Group Description:
Placebo was defined as 50% nitrogen and 50% oxygen for 40 minutes.
Nitrous oxide treatment was defined as 50% nitrous oxide and 50% oxygen for 40 minutes.
Overall Number of Participants Analyzed 39 38
Measure Type: Number
Unit of Measure: participants
Somewhat improved, -1 5 2
No change, 0 28 34
Somewhat worsened, 1 5 2
Significantly worsened, 2 1 0
3.Secondary Outcome
Title Patients' Global Impression of Change
Hide Description Participant-reported perception of change in impact of tinnitus on quality of life since receiving each intervention
Time Frame 1 week post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Nitrous Oxide
Hide Arm/Group Description:
Placebo was defined as 50% nitrogen and 50% oxygen for 40 minutes.
Nitrous oxide treatment was defined as 50% nitrous oxide and 50% oxygen for 40 minutes.
Overall Number of Participants Analyzed 37 37
Measure Type: Count of Participants
Unit of Measure: Participants
No change or worsened
24
  64.9%
20
  54.1%
Almost the same
5
  13.5%
10
  27.0%
A little better
2
   5.4%
2
   5.4%
Somewhat better
4
  10.8%
0
   0.0%
Moderately better
1
   2.7%
4
  10.8%
Better, definite improvement
1
   2.7%
1
   2.7%
Great deal better, considerable improvement
0
   0.0%
0
   0.0%
Time Frame 9 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Nitrous Oxide
Hide Arm/Group Description

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 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.

All-Cause Mortality
Placebo Nitrous Oxide
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)      0/40 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Nitrous Oxide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/40 (0.00%)      0/40 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Nitrous Oxide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/40 (0.00%)      3/40 (7.50%)    
General disorders     
Nausea  [1]  0/40 (0.00%)  0 1/40 (2.50%)  1
Lightheadedness  [1]  0/40 (0.00%)  0 1/40 (2.50%)  1
Panic attack  [1]  0/40 (0.00%)  0 1/40 (2.50%)  1
Indicates events were collected by systematic assessment
[1]
Temporary, fully resolved
Limitations included ineffective blinding, with significantly greater than 50% of participants correctly guessing the intervention received.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jay F. Piccirillo, MD, FACS
Organization: Washington University School of Medicine in St. Louis
Phone: (314) 362-8641
EMail: piccirij@wustl.edu
Publications:
Standards for Basic Anesthetic Monitoring. Committee of Origin: Standards and Practice Parameters (Approved by the ASA House of Delegates on October 21, 1986, last amended on October 20, 2010, and last affirmed on October 28, 2016) https://www.asahq.org/~/media/Sites/ASAHQ/Files/Public/Resources/standards-guidelines/standards-for-basic-anesthetic-monitoring.pdf
Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03365011     History of Changes
Other Study ID Numbers: 201606104
First Submitted: May 15, 2017
First Posted: December 7, 2017
Results First Submitted: April 23, 2018
Results First Posted: November 6, 2018
Last Update Posted: December 14, 2018