Trial Outcomes & Findings for Investigation of the Role of Steroids in Enhancing Voice Therapy Outcomes (NCT NCT02286960)
NCT ID: NCT02286960
Last Updated: 2020-03-12
Results Overview
Data will be collected via measurement of the hatchmark on the 100mm line for each variable (e.g. 72/100). The higher the score, the higher the deviancy. The final score is the average of scores from each variable.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
36 participants
Primary outcome timeframe
pre-treatment/baseline to 2 months
Results posted on
2020-03-12
Participant Flow
Participant milestones
| Measure |
Steroid
Prednizone pills. 4 day course 2 x 20mg per day.
Steroid: A short 4 day course is administered to the first group of patients with voice disorders before the initiation of voice therapy.
|
Placebo
Lactose Pills. 4 day course 2 x 20mg per day.
Lactose Pills: 4 day course 2 x 20mg per da
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
17
|
|
Overall Study
COMPLETED
|
16
|
14
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Steroid
Prednizone pills. 4 day course 2 x 20mg per day.
Steroid: A short 4 day course is administered to the first group of patients with voice disorders before the initiation of voice therapy.
|
Placebo
Lactose Pills. 4 day course 2 x 20mg per day.
Lactose Pills: 4 day course 2 x 20mg per da
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
Baseline Characteristics
Investigation of the Role of Steroids in Enhancing Voice Therapy Outcomes
Baseline characteristics by cohort
| Measure |
Steroid
n=16 Participants
Prednizone pills. 4 day course 2 x 20mg per day.
Steroid: A short 4 day course is administered to the first group of patients with voice disorders before the initiation of voice therapy.
|
Placebo
n=14 Participants
Lactose Pills. 4 day course 2 x 20mg per day.
Lactose Pills: 4 day course 2 x 20mg per da
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: pre-treatment/baseline to 2 monthsData will be collected via measurement of the hatchmark on the 100mm line for each variable (e.g. 72/100). The higher the score, the higher the deviancy. The final score is the average of scores from each variable.
Outcome measures
| Measure |
Steroid
n=14 Participants
Prednizone pills. 4 day course 2 x 20mg per day.
Steroid: A short 4 day course is administered to the first group of patients with voice disorders before the initiation of voice therapy.
|
Placebo
n=13 Participants
Lactose Pills. 4 day course 2 x 20mg per day.
Lactose Pills: 4 day course 2 x 20mg per da
|
|---|---|---|
|
Change in Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) Score From Baseline to 2 Months
|
0.72 score on a scale
Standard Deviation 0.21
|
0.65 score on a scale
Standard Deviation 0.14
|
SECONDARY outcome
Timeframe: pre-treatment/baseline to 2 monthsStill images of the glottis will be obtained from the video such that the vocal folds are captured in an open position (at least 40 degrees at the anterior commissure). Image J software (NIH) will then be used to outline the lesion and measure the length of the ipsilateral vocal fold.
Outcome measures
| Measure |
Steroid
n=14 Participants
Prednizone pills. 4 day course 2 x 20mg per day.
Steroid: A short 4 day course is administered to the first group of patients with voice disorders before the initiation of voice therapy.
|
Placebo
n=13 Participants
Lactose Pills. 4 day course 2 x 20mg per day.
Lactose Pills: 4 day course 2 x 20mg per da
|
|---|---|---|
|
Change in Lesion Size From Baseline to 2 Months
|
-0.4694 mm
Standard Deviation 0.5494
|
0.2788 mm
Standard Deviation 0.3026
|
SECONDARY outcome
Timeframe: Pre-treatment/baseline to following treatment/2 monthsA change in VHI scores from pre-treatment to following treatment. Scores can range from 0-120: 0-30: Mild Minimal amount of handicap 31-60: Moderate Often seen in patients with vocal nodules, polyps, or cysts 60-120: Severe Often seen
Outcome measures
| Measure |
Steroid
n=14 Participants
Prednizone pills. 4 day course 2 x 20mg per day.
Steroid: A short 4 day course is administered to the first group of patients with voice disorders before the initiation of voice therapy.
|
Placebo
n=13 Participants
Lactose Pills. 4 day course 2 x 20mg per day.
Lactose Pills: 4 day course 2 x 20mg per da
|
|---|---|---|
|
Change in Voice Handicap Index (VHI) Scores From Baseline to 2 Months.
|
0.35 score on a scale
Interval -0.2 to 0.9
|
0.40 score on a scale
Interval 0.15 to 0.95
|
SECONDARY outcome
Timeframe: 2 monthsOutcome measures
| Measure |
Steroid
n=14 Participants
Prednizone pills. 4 day course 2 x 20mg per day.
Steroid: A short 4 day course is administered to the first group of patients with voice disorders before the initiation of voice therapy.
|
Placebo
n=13 Participants
Lactose Pills. 4 day course 2 x 20mg per day.
Lactose Pills: 4 day course 2 x 20mg per da
|
|---|---|---|
|
Number of Participants That Showed Improved (Lower) Average Decibels (db) Output.
|
14 Participants
|
13 Participants
|
Adverse Events
Steroid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place