An interventional study of Straw phonation in air and straw phonation in water in Voice Disorders, sponsored by University Ghent. Completed at 1 site in Belgium. Open to participants aged 17 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-30.
Sponsored by University Ghent · Not applicable, Interventional, and Treatment
The first objective of this research is to investigate the immediate effects of three semi-occluded vocal tract (SOVT) exercises (straw phonation in air, straw phonation in 2cm water, and straw phonation in 5cm water) on (supra)glottic activity of vocally healthy participants and patients with voice disorders (dysphonia) visualized with laryngovideostroboscopy.
Participants will receive a flexible laryngovideostroboscopy, both during normal phonation and during the specific SOVT exercise. These videos will be randomly and blindly evaluated by two experts using the Voice-Vibratory Assessment with Laryngeal Imaging (VALI) rating form (Poburka et al., 2017).
Researchers will compare the effects of these SOVT exercises on the (supra)glottic activity with the effects found in a control group producing /u/ phonation, using a randomized controlled trial.
Participants will receive a short-term intensive therapy with the specific SOVT exercise across four weeks.
Immediately after the therapy program and at 1 and 3 months follow-up, the voice of the participants will be re-evaluated.
77 studies on the registry are indexed under Voice Disorders; 17 are open to participants now.
This study's enrollment of 58 is above the median of 41 across 54 interventional studies indexed under Voice Disorders.
Browse Voice Disorders studies →University Ghent is the lead sponsor of 350 studies on the registry; 86 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients:
Inclusion criteria are aged between 17 and 50 years, and diagnosed with dysphonia by an otorhinolaryngologist and SLP experienced in voice diagnostics. Exclusion criteria are previous or current participation in voice therapy, previous phonosurgical interventions, pregnancy, smoking, nasal or ear diseases, and neurological disorders.
Vocally healthy participants:
Inclusion criteria are aged between 17 and 50 years. Exclusion criteria are dagnosed with dysphonia, previous or current participation in voice therapy, previous phonosurgical interventions, pregnancy, smoking, nasal or ear diseases, and neurological disorders.
Participants will be asked to phonate an /u/ vowel through a stirring straw in air with slightly pursed lips and a soft voice onset.
Behavioral: Straw phonation in air
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.
Behavioral: straw phonation in 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.
Behavioral: straw phonation in water
Participants will be asked to phonate an /u/ vowel with slightly pursed lips and a soft voice onset but without a straw.
Behavioral: /u/ phonation
Phonation (/u/ vowel) through a stirring straw (3 mm diameter, 20cm length) in air
Also known as: steady SOVT exercise
Phonation (/u/ vowel) through a stirring straw (3 mm diameter, 20cm length) in 2 cm or 5 cm water
Also known as: water-resistance therapy, fluctuating SOVT exercise
/u/ phonation without a straw, control condition
Also known as: articulatory/steady SOVT exercise
(Supra)Glottic Activity: Amplitude of Vibration
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.
Time frame: baseline (before the intervention)
Supraglottic Activity: Anteroposterior Compression
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.
Time frame: baseline (before the intervention)
Voice Quality Index 1: Dysphonia Severity Index (DSI)
DSI: 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.
Time frame: baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-up
Voice Quality Index 2: Acoustic Voice Quality Index (AVQI)
A 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.
Time frame: baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-up
Self-report 1: Voice Handicap Index (VHI)
VHI: A lower index indicates less impact of the voice impairment on the quality of life. The VHI ranges from 0 to 120.
Time frame: baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-up
Self-report 2: Vocal Tract Discomfort Scale (VTDS)
VTDS: A lower index indicates less discomfort in the vocal tract. The index ranges from 0 to 96.
Time frame: baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-up
Self-report 3: Vocal Fatigue Index (VFI)
VFI: A lower index indicates less vocal fatigue. The index ranges from 0 to 76.
Time frame: baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-up
| Milestone | Straw Phonation in Air | Straw Phonation in 2 cm Water | Straw Phonation in 5 cm Water | /u/ Control Condition |
|---|---|---|---|---|
| Started | 15 | 15 | 14 | 14 |
| Completed | 14 | 13 | 13 | 12 |
| Not completed | 1 | 2 | 1 | 2 |
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.
| percentage | Straw Phonation in Air | Straw Phonation in 2 cm Water | Straw Phonation in 5 cm Water | /u/ Control Condition |
|---|---|---|---|---|
| SOVT phonation | 37.7 (33.6 to 41.7) | 32.5 (28.0 to 37.0) | 28.8 (24.5 to 33.2) | 37.1 (32.6 to 41.6) |
| habitual phonation | 36.7 (32.6 to 40.7) | 39.6 (35.1 to 44.1) | 40.0 (35.6 to 44.4) | 34.6 (30.1 to 39.1) |
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.
| units on a scale | Straw Phonation in Air | Straw Phonation in 2 cm Water | Straw Phonation in 5 cm Water | /u/ Control Condition |
|---|---|---|---|---|
| SOVT phonation | 2.6 (1.9 to 3.3) | 2.3 (1.4 to 3.1) | 2.9 (2.1 to 3.7) | 1.3 (0.4 to 2.1) |
| habitual phonation | 1.2 (0.5 to 1.9) | 1.0 (0.2 to 1.8) | 1.4 (0.7 to 2.2) | 1.4 (0.7 to 2.3) |
DSI: 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.
| score on a scale | Straw Phonation in Air | Straw Phonation in 2 cm Water | Straw Phonation in 5 cm Water | /u/ Control Condition |
|---|---|---|---|---|
| Baseline | 1.0 (-0.3 to 2.2) | 1.3 (0.0 to 2.5) | 0.7 (-2.5 to 2.0) | 1.0 (-0.3 to 2.2) |
| 1 month (immediately after the intervention) | 1.7 (0.4 to 3.0) | 1.2 (-0.3 to 2.4) | 0.9 (-0.3 to 2.2) | 0.9 (-0.4 to 2.2) |
| 1 month follow-up | 2.4 (1.1 to 3.6) | 3.0 (1.7 to 4.4) | 2.3 (1.0 to 3.5) | 1.3 (0.1 to 2.6) |
| 3 months follow-up | 2.3 (1.1 to 3.6) | 2.5 (1.2 to 3.9) | 1.9 (0.7 to 3.2) | 1.5 (0.1 to 2.9) |
A 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.
| score on a scale | Straw Phonation in Air | Straw Phonation in 2 cm Water | Straw Phonation in 5 cm Water | /u/ Control Condition |
|---|---|---|---|---|
| baseline | 3.63 (3.07 to 4.20) | 3.69 (3.12 to 4.25) | 4.12 (3.56 to 4.69) | 3.70 (3.14 to 4.27) |
| 1 month | 3.86 (3.30 to 4.43) | 3.12 (2.56 to 3.69) | 3.73 (3.17 to 4.30) | 3.41 (2.84 to 3.97) |
| 1 month follow-up | 3.64 (3.08 to 4.21) | 3.22 (2.63 to 3.80) | 3.74 (3.17 to 4.30) | 3.57 (2.99 to 4.16) |
| 3 months follow-up | 3.84 (3.27 to 4.40) | 3.22 (2.64 to 3.81) | 3.86 (3.29 to 4.42) | 3.15 (2.53 to 3.76) |
VHI: A lower index indicates less impact of the voice impairment on the quality of life. The VHI ranges from 0 to 120.
| score on a scale | Straw Phonation in Air | Straw Phonation in 2 cm Water | Straw Phonation in 5 cm Water | /u/ Control Condition |
|---|---|---|---|---|
| baseline | 9 (1 to 17) | 12 (4 to 20) | 19 (11 to 27) | 13 (5 to 20) |
| 1 month | 7 (0 to 15) | 12 (4 to 20) | 17 (9 to 24) | 13 (5 to 21) |
| 1 month follow-up | 9 (1 to 16) | 11 (3 to 19) | 18 (10 to 25) | 9 (1 to 17) |
| 3 months follow-up | 11 (3 to 19) | 16 (8 to 24) | 18 (10 to 25) | 11 (3 to 19) |
VTDS: A lower index indicates less discomfort in the vocal tract. The index ranges from 0 to 96.
| score on a scale | Straw Phonation in Air | Straw Phonation in 2 cm Water | Straw Phonation in 5 cm Water | /u/ Control Condition |
|---|---|---|---|---|
| baseline | 16 (7 to 25) | 21 (12 to 30) | 25 (16 to 34) | 16 (6 to 25) |
| 1 month | 13 (4 to 22) | 19 (10 to 28) | 21 (12 to 30) | 16 (7 to 25) |
| 1 month follow-up | 13 (3 to 22) | 16 (7 to 25) | 19 (10 to 28) | 21 (12 to 30) |
| 3 months follow-up | 13 (4 to 22) | 18 (9 to 27) | 20 (11 to 29) | 12 (2 to 21) |
VFI: A lower index indicates less vocal fatigue. The index ranges from 0 to 76.
| score on a scale | Straw Phonation in Air | Straw Phonation in 2 cm Water | Straw Phonation in 5 cm Water | /u/ Control Condition |
|---|---|---|---|---|
| baseline | 14 (8 to 20) | 20 (14 to 26) | 19 (13 to 25) | 15 (9 to 21) |
| 1 month | 11 (5 to 17) | 14 (8 to 20) | 16 (10 to 22) | 15 (9 to 21) |
| 1 month follow-up | 11 (5 to 16) | 12 (6 to 18) | 17 (11 to 23) | 14 (8 to 20) |
| 3 months follow-up | 13 (7 to 19) | 17 (11 to 23) | 19 (13 to 25) | 15 (9 to 22) |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Straw Phonation in Air | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Straw Phonation in 2 cm Water | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Straw Phonation in 5 cm Water | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| /u/ Control Condition | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Age, Categorical(Participants) | Straw Phonation in Air | Straw Phonation in 2 cm Water | Straw Phonation in 5 cm Water | /u/ Control Condition | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 15 | 15 | 14 | 14 | 58 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Straw Phonation in Air | Straw Phonation in 2 cm Water | Straw Phonation in 5 cm Water | /u/ Control Condition | Total |
|---|---|---|---|---|---|
| Mean | 18.7 (17 to 20) | 18.7 (17 to 20) | 18.7 (17 to 20) | 18.7 (17 to 20) | 18.7 (17 to 20) |
| Sex: Female, Male(Participants) | Straw Phonation in Air | Straw Phonation in 2 cm Water | Straw Phonation in 5 cm Water | /u/ Control Condition | Total |
|---|---|---|---|---|---|
| Female | 15 | 15 | 14 | 14 | 58 |
| Male | 0 | 0 | 0 | 0 | 0 |
| Race and Ethnicity Not Collected(Participants) | Straw Phonation in Air | Straw Phonation in 2 cm Water | Straw Phonation in 5 cm Water | /u/ Control Condition | Total |
|---|---|---|---|---|---|
| Count of participants | — | — | — | — | 0 |
| Region of Enrollment(Participants) | Straw Phonation in Air | Straw Phonation in 2 cm Water | Straw Phonation in 5 cm Water | /u/ Control Condition | Total |
|---|---|---|---|---|---|
| Belgium | 15 | 15 | 14 | 14 | 58 |
| smoking(Participants) | Straw Phonation in Air | Straw Phonation in 2 cm Water | Straw Phonation in 5 cm Water | /u/ Control Condition | Total |
|---|---|---|---|---|---|
| Count of participants | 1 | 0 | 0 | 0 | 1 |
| organic vocal fold pathology(Participants) | Straw Phonation in Air | Straw Phonation in 2 cm Water | Straw Phonation in 5 cm Water | /u/ Control Condition | Total |
|---|---|---|---|---|---|
| Count of participants | 0 | 1 | 1 | 1 | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2021 to primary completion in Mar 2023, 17 months.
Results were first posted in Oct 2024, 1 year 7 months after primary completion.
Of 30 interventional studies with no phase under Voice Disorders, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 48. This study's 17 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.