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| Name | Class |
|---|---|
| Research Foundation Flanders | OTHER |
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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.
The second objective of this research is to investigate the short- and long-term effects of the three SOVT therapy approaches on the (supra)glottic activity, voice quality and self-report of patients with voice disorders (dysphonia).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| straw phonation in air | Experimental | 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 2 cm water | Experimental | 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 5 cm water | Experimental | 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. |
|
| /u/ control condition | Active Comparator | Participants will be asked to phonate an /u/ vowel with slightly pursed lips and a soft voice onset but without a straw. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Straw phonation in air | Behavioral | Phonation (/u/ vowel) through a stirring straw (3 mm diameter, 20cm length) in air |
|
| Measure | Description | Time Frame |
|---|---|---|
| (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. | 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. | baseline (before the intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-up |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Kristiane Van Lierde, PhD | University Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Rehabilitation Sciences, Ghent University (Hospital) | Ghent | East-Flanders | 9000 | Belgium |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | /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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Straw Phonation in 2 cm Water |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | (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. | Posted | Mean | Inter-Quartile Range | percentage | baseline (before the intervention) |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Iris Meerschman | Ghent University | +32499294636 | iris.meerschman@ugent.be |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 3, 2023 | Aug 6, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014832 | Voice Disorders |
| D007818 | Laryngeal Diseases |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000388 | Air |
| D014867 | Water |
| D010699 | Phonation |
| ID | Term |
|---|---|
| D001272 | Atmosphere |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
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| straw phonation in water | Behavioral | Phonation (/u/ vowel) through a stirring straw (3 mm diameter, 20cm length) in 2 cm or 5 cm water |
|
|
| /u/ phonation | Behavioral | /u/ phonation without a straw, control condition |
|
|
| 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. | 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. | 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. | 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. | baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-up |
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 |
| BG002 | 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 |
| BG003 | /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 |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| smoking | Count of Participants | Participants |
|
| organic vocal fold pathology | Count of Participants | Participants |
|
| OG001 | 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 |
| OG002 | 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 |
| OG003 | /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 |
|
|
| Primary | 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. | Posted | Mean | Inter-Quartile Range | units on a scale | baseline (before the intervention) |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-up |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-up |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-up |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-up |
|
|
|
| Secondary | Self-report 3: Vocal Fatigue Index (VFI) | VFI: A lower index indicates less vocal fatigue. The index ranges from 0 to 76. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-up |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | 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 | 0 | 13 | 0 | 13 | 0 | 13 |
| EG002 | 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 | 0 | 13 | 0 | 13 | 0 | 13 |
| EG003 | /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 | 0 | 12 | 0 | 12 | 0 | 12 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008685 |
| Meteorological Concepts |
| D004778 | Environment and Public Health |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| habitual phonation |
|
| 1 month (immediately after the intervention) |
|
| 1 month follow-up |
|
| 3 months follow-up |
|
| 1 month |
|
| 1 month follow-up |
|
| 3 months follow-up |
|
| 1 month |
|
| 1 month follow-up |
|
| 3 months follow-up |
|
| 1 month |
|
| 1 month follow-up |
|
| 3 months follow-up |
|
| 1 month |
|
| 1 month follow-up |
|
| 3 months follow-up |
|