Trial Outcomes & Findings for Voice Therapy With a Semi-occluded Vocal Tract (NCT NCT06137131)
NCT ID: NCT06137131
Last Updated: 2024-10-30
Results Overview
Laryngeal function determined with the Voice-Vibratory Assessment with Laryngeal Imaging (VALI) rating form (Poburka et al., 2017). Amplitude of vibration: magnitude of lateral movement of the vocal folds. This is a visual-perceptual evaluation based on the video samples of the strobovideolaryngoscopy. Raters score the magnitude of lateral movement of the vocal folds based on the graphic of the VALI form ranging from 0 to 10, this number is then multiplied by 10 to obtain a percentage. Lower percentages mean a smaller amplitude of vibration, higher percentages mean a larger amplitude of vibration.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
58 participants
Primary outcome timeframe
baseline (before the intervention)
Results posted on
2024-10-30
Participant Flow
Participant milestones
| Measure |
Straw Phonation in Air
Participants will be asked to phonate an /u/ vowel through a stirring straw in air with slightly pursed lips and a soft voice onset.
Straw phonation in air: Phonation (/u/ vowel) through a stirring straw (3 mm diameter, 20cm length) in air
|
Straw Phonation in 2 cm Water
Participants will be asked to phonate an /u/ vowel through a stirring straw, placed 2 cm below the water surface, with slightly pursed lips and a soft voice onset.
straw phonation in water: Phonation (/u/ vowel) through a stirring straw (3 mm diameter, 20cm length) in 2 cm or 5 cm water
|
Straw Phonation in 5 cm Water
Participants will be asked to phonate an /u/ vowel through a stirring straw, placed 5 cm below the water surface, with slightly pursed lips and a soft voice onset.
straw phonation in water: Phonation (/u/ vowel) through a stirring straw (3 mm diameter, 20cm length) in 2 cm or 5 cm water
|
/u/ Control Condition
Participants will be asked to phonate an /u/ vowel with slightly pursed lips and a soft voice onset but without a straw.
/u/ phonation: /u/ phonation without a straw, control condition
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
14
|
14
|
|
Overall Study
COMPLETED
|
14
|
13
|
13
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Straw Phonation in Air
n=15 Participants
Participants will be asked to phonate an /u/ vowel through a stirring straw in air with slightly pursed lips and a soft voice onset.
Straw phonation in air: Phonation (/u/ vowel) through a stirring straw (3 mm diameter, 20cm length) in air
|
Straw Phonation in 2 cm Water
n=15 Participants
Participants will be asked to phonate an /u/ vowel through a stirring straw, placed 2 cm below the water surface, with slightly pursed lips and a soft voice onset.
straw phonation in water: Phonation (/u/ vowel) through a stirring straw (3 mm diameter, 20cm length) in 2 cm or 5 cm water
|
Straw Phonation in 5 cm Water
n=14 Participants
Participants will be asked to phonate an /u/ vowel through a stirring straw, placed 5 cm below the water surface, with slightly pursed lips and a soft voice onset.
straw phonation in water: Phonation (/u/ vowel) through a stirring straw (3 mm diameter, 20cm length) in 2 cm or 5 cm water
|
/u/ Control Condition
n=14 Participants
Participants will be asked to phonate an /u/ vowel with slightly pursed lips and a soft voice onset but without a straw.
/u/ phonation: /u/ phonation without a straw, control condition
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=58 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
14 Participants
n=14 Participants
|
14 Participants
n=14 Participants
|
58 Participants
n=58 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=58 Participants
|
|
Age, Continuous
|
18.7 years
n=15 Participants
|
18.7 years
n=15 Participants
|
18.7 years
n=14 Participants
|
18.7 years
n=14 Participants
|
18.7 years
n=58 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
14 Participants
n=14 Participants
|
14 Participants
n=14 Participants
|
58 Participants
n=58 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=58 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Belgium
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
14 Participants
n=14 Participants
|
14 Participants
n=14 Participants
|
58 Participants
n=58 Participants
|
|
smoking
|
1 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
1 Participants
n=58 Participants
|
|
organic vocal fold pathology
|
0 Participants
n=15 Participants
|
1 Participants
n=15 Participants
|
1 Participants
n=14 Participants
|
1 Participants
n=14 Participants
|
3 Participants
n=58 Participants
|
PRIMARY outcome
Timeframe: baseline (before the intervention)Laryngeal function determined with the Voice-Vibratory Assessment with Laryngeal Imaging (VALI) rating form (Poburka et al., 2017). Amplitude of vibration: magnitude of lateral movement of the vocal folds. This is a visual-perceptual evaluation based on the video samples of the strobovideolaryngoscopy. Raters score the magnitude of lateral movement of the vocal folds based on the graphic of the VALI form ranging from 0 to 10, this number is then multiplied by 10 to obtain a percentage. Lower percentages mean a smaller amplitude of vibration, higher percentages mean a larger amplitude of vibration.
Outcome measures
| Measure |
Straw Phonation in Air
n=14 Participants
Participants will be asked to phonate an /u/ vowel through a stirring straw in air with slightly pursed lips and a soft voice onset.
Straw phonation in air: Phonation (/u/ vowel) through a stirring straw (3 mm diameter, 20cm length) in air
|
Straw Phonation in 2 cm Water
n=13 Participants
Participants will be asked to phonate an /u/ vowel through a stirring straw, placed 2 cm below the water surface, with slightly pursed lips and a soft voice onset.
straw phonation in water: Phonation (/u/ vowel) through a stirring straw (3 mm diameter, 20cm length) in 2 cm or 5 cm water
|
Straw Phonation in 5 cm Water
n=13 Participants
Participants will be asked to phonate an /u/ vowel through a stirring straw, placed 5 cm below the water surface, with slightly pursed lips and a soft voice onset.
straw phonation in water: Phonation (/u/ vowel) through a stirring straw (3 mm diameter, 20cm length) in 2 cm or 5 cm water
|
/u/ Control Condition
n=12 Participants
Participants will be asked to phonate an /u/ vowel with slightly pursed lips and a soft voice onset but without a straw.
/u/ phonation: /u/ phonation without a straw, control condition
|
|---|---|---|---|---|
|
(Supra)Glottic Activity: Amplitude of Vibration
SOVT phonation
|
37.7 percentage
Interval 33.6 to 41.7
|
32.5 percentage
Interval 28.0 to 37.0
|
28.8 percentage
Interval 24.5 to 33.2
|
37.1 percentage
Interval 32.6 to 41.6
|
|
(Supra)Glottic Activity: Amplitude of Vibration
habitual phonation
|
36.7 percentage
Interval 32.6 to 40.7
|
39.6 percentage
Interval 35.1 to 44.1
|
40.0 percentage
Interval 35.6 to 44.4
|
34.6 percentage
Interval 30.1 to 39.1
|
PRIMARY outcome
Timeframe: baseline (before the intervention)Laryngeal function determined with the VALI form (Poburka et al, 2017). Anteroposterior supraglottic compression: constriction of the supraglottic structures in the anteroposterior dimension. This is a visual-perceptual evaluation based on the video samples of the strobovideolaryngoscopy. Raters score the supraglottic compression based on the graphic of the VALI form on a scale ranging from 0 to 5 (with the aid of concentric circles). The higher the number, the more supraglottic compression. More supraglottic compression is often seen as a negative outcome, however it might be a beneficial effect seen in SOVT phonation studied here.
Outcome measures
| Measure |
Straw Phonation in Air
n=14 Participants
Participants will be asked to phonate an /u/ vowel through a stirring straw in air with slightly pursed lips and a soft voice onset.
Straw phonation in air: Phonation (/u/ vowel) through a stirring straw (3 mm diameter, 20cm length) in air
|
Straw Phonation in 2 cm Water
n=13 Participants
Participants will be asked to phonate an /u/ vowel through a stirring straw, placed 2 cm below the water surface, with slightly pursed lips and a soft voice onset.
straw phonation in water: Phonation (/u/ vowel) through a stirring straw (3 mm diameter, 20cm length) in 2 cm or 5 cm water
|
Straw Phonation in 5 cm Water
n=13 Participants
Participants will be asked to phonate an /u/ vowel through a stirring straw, placed 5 cm below the water surface, with slightly pursed lips and a soft voice onset.
straw phonation in water: Phonation (/u/ vowel) through a stirring straw (3 mm diameter, 20cm length) in 2 cm or 5 cm water
|
/u/ Control Condition
n=12 Participants
Participants will be asked to phonate an /u/ vowel with slightly pursed lips and a soft voice onset but without a straw.
/u/ phonation: /u/ phonation without a straw, control condition
|
|---|---|---|---|---|
|
Supraglottic Activity: Anteroposterior Compression
SOVT phonation
|
2.6 units on a scale
Interval 1.9 to 3.3
|
2.3 units on a scale
Interval 1.4 to 3.1
|
2.9 units on a scale
Interval 2.1 to 3.7
|
1.3 units on a scale
Interval 0.4 to 2.1
|
|
Supraglottic Activity: Anteroposterior Compression
habitual phonation
|
1.2 units on a scale
Interval 0.5 to 1.9
|
1.0 units on a scale
Interval 0.2 to 1.8
|
1.4 units on a scale
Interval 0.7 to 2.2
|
1.4 units on a scale
Interval 0.7 to 2.3
|
SECONDARY outcome
Timeframe: baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-upDSI: A higher index indicates a better voice quality. The index ranges from -5 to +5 for severely dysphonic to normal voices. A more negative index indicates a worse voice quality. Values \> +5 are possible in subjects with excellent vocal capacities. A DSI = +1.6 is the threshold separating normophonic from dysphonic persons.
Outcome measures
| Measure |
Straw Phonation in Air
n=8 Participants
Participants will be asked to phonate an /u/ vowel through a stirring straw in air with slightly pursed lips and a soft voice onset.
Straw phonation in air: Phonation (/u/ vowel) through a stirring straw (3 mm diameter, 20cm length) in air
|
Straw Phonation in 2 cm Water
n=8 Participants
Participants will be asked to phonate an /u/ vowel through a stirring straw, placed 2 cm below the water surface, with slightly pursed lips and a soft voice onset.
straw phonation in water: Phonation (/u/ vowel) through a stirring straw (3 mm diameter, 20cm length) in 2 cm or 5 cm water
|
Straw Phonation in 5 cm Water
n=8 Participants
Participants will be asked to phonate an /u/ vowel through a stirring straw, placed 5 cm below the water surface, with slightly pursed lips and a soft voice onset.
straw phonation in water: Phonation (/u/ vowel) through a stirring straw (3 mm diameter, 20cm length) in 2 cm or 5 cm water
|
/u/ Control Condition
n=8 Participants
Participants will be asked to phonate an /u/ vowel with slightly pursed lips and a soft voice onset but without a straw.
/u/ phonation: /u/ phonation without a straw, control condition
|
|---|---|---|---|---|
|
Voice Quality Index 1: Dysphonia Severity Index (DSI)
Baseline
|
1.0 score on a scale
Interval -0.3 to 2.2
|
1.3 score on a scale
Interval 0.0 to 2.5
|
0.7 score on a scale
Interval -2.5 to 2.0
|
1.0 score on a scale
Interval -0.3 to 2.2
|
|
Voice Quality Index 1: Dysphonia Severity Index (DSI)
1 month (immediately after the intervention)
|
1.7 score on a scale
Interval 0.4 to 3.0
|
1.2 score on a scale
Interval -0.3 to 2.4
|
0.9 score on a scale
Interval -0.3 to 2.2
|
0.9 score on a scale
Interval -0.4 to 2.2
|
|
Voice Quality Index 1: Dysphonia Severity Index (DSI)
1 month follow-up
|
2.4 score on a scale
Interval 1.1 to 3.6
|
3.0 score on a scale
Interval 1.7 to 4.4
|
2.3 score on a scale
Interval 1.0 to 3.5
|
1.3 score on a scale
Interval 0.1 to 2.6
|
|
Voice Quality Index 1: Dysphonia Severity Index (DSI)
3 months follow-up
|
2.3 score on a scale
Interval 1.1 to 3.6
|
2.5 score on a scale
Interval 1.2 to 3.9
|
1.9 score on a scale
Interval 0.7 to 3.2
|
1.5 score on a scale
Interval 0.1 to 2.9
|
SECONDARY outcome
Timeframe: baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-upA lower AVQI indicates a better voice quality. The index ranges from 0 to 10 for normal to severely dysphonic voices. An AVQI of 2.95 is the threshold separating normophonic from dysphonic persons.
Outcome measures
| Measure |
Straw Phonation in Air
n=8 Participants
Participants will be asked to phonate an /u/ vowel through a stirring straw in air with slightly pursed lips and a soft voice onset.
Straw phonation in air: Phonation (/u/ vowel) through a stirring straw (3 mm diameter, 20cm length) in air
|
Straw Phonation in 2 cm Water
n=8 Participants
Participants will be asked to phonate an /u/ vowel through a stirring straw, placed 2 cm below the water surface, with slightly pursed lips and a soft voice onset.
straw phonation in water: Phonation (/u/ vowel) through a stirring straw (3 mm diameter, 20cm length) in 2 cm or 5 cm water
|
Straw Phonation in 5 cm Water
n=8 Participants
Participants will be asked to phonate an /u/ vowel through a stirring straw, placed 5 cm below the water surface, with slightly pursed lips and a soft voice onset.
straw phonation in water: Phonation (/u/ vowel) through a stirring straw (3 mm diameter, 20cm length) in 2 cm or 5 cm water
|
/u/ Control Condition
n=8 Participants
Participants will be asked to phonate an /u/ vowel with slightly pursed lips and a soft voice onset but without a straw.
/u/ phonation: /u/ phonation without a straw, control condition
|
|---|---|---|---|---|
|
Voice Quality Index 2: Acoustic Voice Quality Index (AVQI)
baseline
|
3.63 score on a scale
Interval 3.07 to 4.2
|
3.69 score on a scale
Interval 3.12 to 4.25
|
4.12 score on a scale
Interval 3.56 to 4.69
|
3.70 score on a scale
Interval 3.14 to 4.27
|
|
Voice Quality Index 2: Acoustic Voice Quality Index (AVQI)
1 month
|
3.86 score on a scale
Interval 3.3 to 4.43
|
3.12 score on a scale
Interval 2.56 to 3.69
|
3.73 score on a scale
Interval 3.17 to 4.3
|
3.41 score on a scale
Interval 2.84 to 3.97
|
|
Voice Quality Index 2: Acoustic Voice Quality Index (AVQI)
1 month follow-up
|
3.64 score on a scale
Interval 3.08 to 4.21
|
3.22 score on a scale
Interval 2.63 to 3.8
|
3.74 score on a scale
Interval 3.17 to 4.3
|
3.57 score on a scale
Interval 2.99 to 4.16
|
|
Voice Quality Index 2: Acoustic Voice Quality Index (AVQI)
3 months follow-up
|
3.84 score on a scale
Interval 3.27 to 4.4
|
3.22 score on a scale
Interval 2.64 to 3.81
|
3.86 score on a scale
Interval 3.29 to 4.42
|
3.15 score on a scale
Interval 2.53 to 3.76
|
SECONDARY outcome
Timeframe: baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-upVHI: A lower index indicates less impact of the voice impairment on the quality of life. The VHI ranges from 0 to 120.
Outcome measures
| Measure |
Straw Phonation in Air
n=8 Participants
Participants will be asked to phonate an /u/ vowel through a stirring straw in air with slightly pursed lips and a soft voice onset.
Straw phonation in air: Phonation (/u/ vowel) through a stirring straw (3 mm diameter, 20cm length) in air
|
Straw Phonation in 2 cm Water
n=8 Participants
Participants will be asked to phonate an /u/ vowel through a stirring straw, placed 2 cm below the water surface, with slightly pursed lips and a soft voice onset.
straw phonation in water: Phonation (/u/ vowel) through a stirring straw (3 mm diameter, 20cm length) in 2 cm or 5 cm water
|
Straw Phonation in 5 cm Water
n=8 Participants
Participants will be asked to phonate an /u/ vowel through a stirring straw, placed 5 cm below the water surface, with slightly pursed lips and a soft voice onset.
straw phonation in water: Phonation (/u/ vowel) through a stirring straw (3 mm diameter, 20cm length) in 2 cm or 5 cm water
|
/u/ Control Condition
n=8 Participants
Participants will be asked to phonate an /u/ vowel with slightly pursed lips and a soft voice onset but without a straw.
/u/ phonation: /u/ phonation without a straw, control condition
|
|---|---|---|---|---|
|
Self-report 1: Voice Handicap Index (VHI)
baseline
|
9 score on a scale
Interval 1.0 to 17.0
|
12 score on a scale
Interval 4.0 to 20.0
|
19 score on a scale
Interval 11.0 to 27.0
|
13 score on a scale
Interval 5.0 to 20.0
|
|
Self-report 1: Voice Handicap Index (VHI)
1 month
|
7 score on a scale
Interval 0.0 to 15.0
|
12 score on a scale
Interval 4.0 to 20.0
|
17 score on a scale
Interval 9.0 to 24.0
|
13 score on a scale
Interval 5.0 to 21.0
|
|
Self-report 1: Voice Handicap Index (VHI)
1 month follow-up
|
9 score on a scale
Interval 1.0 to 16.0
|
11 score on a scale
Interval 3.0 to 19.0
|
18 score on a scale
Interval 10.0 to 25.0
|
9 score on a scale
Interval 1.0 to 17.0
|
|
Self-report 1: Voice Handicap Index (VHI)
3 months follow-up
|
11 score on a scale
Interval 3.0 to 19.0
|
16 score on a scale
Interval 8.0 to 24.0
|
18 score on a scale
Interval 10.0 to 25.0
|
11 score on a scale
Interval 3.0 to 19.0
|
SECONDARY outcome
Timeframe: baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-upVTDS: A lower index indicates less discomfort in the vocal tract. The index ranges from 0 to 96.
Outcome measures
| Measure |
Straw Phonation in Air
n=8 Participants
Participants will be asked to phonate an /u/ vowel through a stirring straw in air with slightly pursed lips and a soft voice onset.
Straw phonation in air: Phonation (/u/ vowel) through a stirring straw (3 mm diameter, 20cm length) in air
|
Straw Phonation in 2 cm Water
n=8 Participants
Participants will be asked to phonate an /u/ vowel through a stirring straw, placed 2 cm below the water surface, with slightly pursed lips and a soft voice onset.
straw phonation in water: Phonation (/u/ vowel) through a stirring straw (3 mm diameter, 20cm length) in 2 cm or 5 cm water
|
Straw Phonation in 5 cm Water
n=8 Participants
Participants will be asked to phonate an /u/ vowel through a stirring straw, placed 5 cm below the water surface, with slightly pursed lips and a soft voice onset.
straw phonation in water: Phonation (/u/ vowel) through a stirring straw (3 mm diameter, 20cm length) in 2 cm or 5 cm water
|
/u/ Control Condition
n=8 Participants
Participants will be asked to phonate an /u/ vowel with slightly pursed lips and a soft voice onset but without a straw.
/u/ phonation: /u/ phonation without a straw, control condition
|
|---|---|---|---|---|
|
Self-report 2: Vocal Tract Discomfort Scale (VTDS)
baseline
|
16 score on a scale
Interval 7.0 to 25.0
|
21 score on a scale
Interval 12.0 to 30.0
|
25 score on a scale
Interval 16.0 to 34.0
|
16 score on a scale
Interval 6.0 to 25.0
|
|
Self-report 2: Vocal Tract Discomfort Scale (VTDS)
1 month
|
13 score on a scale
Interval 4.0 to 22.0
|
19 score on a scale
Interval 10.0 to 28.0
|
21 score on a scale
Interval 12.0 to 30.0
|
16 score on a scale
Interval 7.0 to 25.0
|
|
Self-report 2: Vocal Tract Discomfort Scale (VTDS)
1 month follow-up
|
13 score on a scale
Interval 3.0 to 22.0
|
16 score on a scale
Interval 7.0 to 25.0
|
19 score on a scale
Interval 10.0 to 28.0
|
21 score on a scale
Interval 12.0 to 30.0
|
|
Self-report 2: Vocal Tract Discomfort Scale (VTDS)
3 months follow-up
|
13 score on a scale
Interval 4.0 to 22.0
|
18 score on a scale
Interval 9.0 to 27.0
|
20 score on a scale
Interval 11.0 to 29.0
|
12 score on a scale
Interval 2.0 to 21.0
|
SECONDARY outcome
Timeframe: baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-upVFI: A lower index indicates less vocal fatigue. The index ranges from 0 to 76.
Outcome measures
| Measure |
Straw Phonation in Air
n=8 Participants
Participants will be asked to phonate an /u/ vowel through a stirring straw in air with slightly pursed lips and a soft voice onset.
Straw phonation in air: Phonation (/u/ vowel) through a stirring straw (3 mm diameter, 20cm length) in air
|
Straw Phonation in 2 cm Water
n=8 Participants
Participants will be asked to phonate an /u/ vowel through a stirring straw, placed 2 cm below the water surface, with slightly pursed lips and a soft voice onset.
straw phonation in water: Phonation (/u/ vowel) through a stirring straw (3 mm diameter, 20cm length) in 2 cm or 5 cm water
|
Straw Phonation in 5 cm Water
n=8 Participants
Participants will be asked to phonate an /u/ vowel through a stirring straw, placed 5 cm below the water surface, with slightly pursed lips and a soft voice onset.
straw phonation in water: Phonation (/u/ vowel) through a stirring straw (3 mm diameter, 20cm length) in 2 cm or 5 cm water
|
/u/ Control Condition
n=8 Participants
Participants will be asked to phonate an /u/ vowel with slightly pursed lips and a soft voice onset but without a straw.
/u/ phonation: /u/ phonation without a straw, control condition
|
|---|---|---|---|---|
|
Self-report 3: Vocal Fatigue Index (VFI)
3 months follow-up
|
13 score on a scale
Interval 7.0 to 19.0
|
17 score on a scale
Interval 11.0 to 23.0
|
19 score on a scale
Interval 13.0 to 25.0
|
15 score on a scale
Interval 9.0 to 22.0
|
|
Self-report 3: Vocal Fatigue Index (VFI)
baseline
|
14 score on a scale
Interval 8.0 to 20.0
|
20 score on a scale
Interval 14.0 to 26.0
|
19 score on a scale
Interval 13.0 to 25.0
|
15 score on a scale
Interval 9.0 to 21.0
|
|
Self-report 3: Vocal Fatigue Index (VFI)
1 month
|
11 score on a scale
Interval 5.0 to 17.0
|
14 score on a scale
Interval 8.0 to 20.0
|
16 score on a scale
Interval 10.0 to 22.0
|
15 score on a scale
Interval 9.0 to 21.0
|
|
Self-report 3: Vocal Fatigue Index (VFI)
1 month follow-up
|
11 score on a scale
Interval 5.0 to 16.0
|
12 score on a scale
Interval 6.0 to 18.0
|
17 score on a scale
Interval 11.0 to 23.0
|
14 score on a scale
Interval 8.0 to 20.0
|
Adverse Events
Straw Phonation in Air
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Straw Phonation in 2 cm Water
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Straw Phonation in 5 cm Water
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
/u/ Control Condition
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