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Voice Therapy With a Semi-occluded Vocal Tract

Voice Therapy With a Semi-occluded Vocal Tract: From Current Challenges to Next Level Efficacy Studies

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06137131
Enrollment
58
Registered
2023-11-18
Start date
2021-10-07
Completion date
2023-03-14
Last updated
2024-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Voice Disorders

Keywords

voice, semi-occluded vocal tract, larynx, randomized controlled trial, efficacy study

Brief summary

1. 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. 2. 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.

Interventions

BEHAVIORALStraw phonation in air

Phonation (/u/ vowel) through a stirring straw (3 mm diameter, 20cm length) in air

BEHAVIORALstraw phonation in water

Phonation (/u/ vowel) through a stirring straw (3 mm diameter, 20cm length) in 2 cm or 5 cm water

BEHAVIORAL/u/ phonation

/u/ phonation without a straw, control condition

Sponsors

Research Foundation Flanders
CollaboratorOTHER
University Ghent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
17 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
(Supra)Glottic Activity: Amplitude of Vibrationbaseline (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.
Supraglottic Activity: Anteroposterior Compressionbaseline (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.

Secondary

MeasureTime frameDescription
Self-report 1: Voice Handicap Index (VHI)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.
Voice Quality Index 1: Dysphonia Severity Index (DSI)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.
Self-report 3: Vocal Fatigue Index (VFI)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.
Self-report 2: Vocal Tract Discomfort Scale (VTDS)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.
Voice Quality Index 2: Acoustic Voice Quality Index (AVQI)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.

Countries

Belgium

Participant flow

Participants by arm

ArmCount
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
15
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
15
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
14
/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
14
Total58

Baseline characteristics

CharacteristicStraw Phonation in AirStraw Phonation in 2 cm WaterStraw Phonation in 5 cm Water/u/ Control ConditionTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
15 Participants15 Participants14 Participants14 Participants58 Participants
Age, Continuous18.7 years18.7 years18.7 years18.7 years18.7 years
organic vocal fold pathology0 Participants1 Participants1 Participants1 Participants3 Participants
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
Belgium
15 Participants15 Participants14 Participants14 Participants58 Participants
Sex: Female, Male
Female
15 Participants15 Participants14 Participants14 Participants58 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants0 Participants
smoking1 Participants0 Participants0 Participants0 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 140 / 130 / 130 / 12
other
Total, other adverse events
0 / 140 / 130 / 130 / 12
serious
Total, serious adverse events
0 / 140 / 130 / 130 / 12

Outcome results

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.

Time frame: baseline (before the intervention)

ArmMeasureGroupValue (MEAN)
Straw Phonation in Air(Supra)Glottic Activity: Amplitude of Vibrationhabitual phonation36.7 percentage
Straw Phonation in Air(Supra)Glottic Activity: Amplitude of VibrationSOVT phonation37.7 percentage
Straw Phonation in 2 cm Water(Supra)Glottic Activity: Amplitude of VibrationSOVT phonation32.5 percentage
Straw Phonation in 2 cm Water(Supra)Glottic Activity: Amplitude of Vibrationhabitual phonation39.6 percentage
Straw Phonation in 5 cm Water(Supra)Glottic Activity: Amplitude of Vibrationhabitual phonation40.0 percentage
Straw Phonation in 5 cm Water(Supra)Glottic Activity: Amplitude of VibrationSOVT phonation28.8 percentage
/u/ Control Condition(Supra)Glottic Activity: Amplitude of Vibrationhabitual phonation34.6 percentage
/u/ Control Condition(Supra)Glottic Activity: Amplitude of VibrationSOVT phonation37.1 percentage
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.

Time frame: baseline (before the intervention)

ArmMeasureGroupValue (MEAN)
Straw Phonation in AirSupraglottic Activity: Anteroposterior CompressionSOVT phonation2.6 units on a scale
Straw Phonation in AirSupraglottic Activity: Anteroposterior Compressionhabitual phonation1.2 units on a scale
Straw Phonation in 2 cm WaterSupraglottic Activity: Anteroposterior Compressionhabitual phonation1.0 units on a scale
Straw Phonation in 2 cm WaterSupraglottic Activity: Anteroposterior CompressionSOVT phonation2.3 units on a scale
Straw Phonation in 5 cm WaterSupraglottic Activity: Anteroposterior CompressionSOVT phonation2.9 units on a scale
Straw Phonation in 5 cm WaterSupraglottic Activity: Anteroposterior Compressionhabitual phonation1.4 units on a scale
/u/ Control ConditionSupraglottic Activity: Anteroposterior CompressionSOVT phonation1.3 units on a scale
/u/ Control ConditionSupraglottic Activity: Anteroposterior Compressionhabitual phonation1.4 units on a scale
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.

Time frame: baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-up

ArmMeasureGroupValue (MEAN)
Straw Phonation in AirSelf-report 1: Voice Handicap Index (VHI)baseline9 score on a scale
Straw Phonation in AirSelf-report 1: Voice Handicap Index (VHI)1 month7 score on a scale
Straw Phonation in AirSelf-report 1: Voice Handicap Index (VHI)1 month follow-up9 score on a scale
Straw Phonation in AirSelf-report 1: Voice Handicap Index (VHI)3 months follow-up11 score on a scale
Straw Phonation in 2 cm WaterSelf-report 1: Voice Handicap Index (VHI)1 month12 score on a scale
Straw Phonation in 2 cm WaterSelf-report 1: Voice Handicap Index (VHI)1 month follow-up11 score on a scale
Straw Phonation in 2 cm WaterSelf-report 1: Voice Handicap Index (VHI)3 months follow-up16 score on a scale
Straw Phonation in 2 cm WaterSelf-report 1: Voice Handicap Index (VHI)baseline12 score on a scale
Straw Phonation in 5 cm WaterSelf-report 1: Voice Handicap Index (VHI)1 month follow-up18 score on a scale
Straw Phonation in 5 cm WaterSelf-report 1: Voice Handicap Index (VHI)1 month17 score on a scale
Straw Phonation in 5 cm WaterSelf-report 1: Voice Handicap Index (VHI)3 months follow-up18 score on a scale
Straw Phonation in 5 cm WaterSelf-report 1: Voice Handicap Index (VHI)baseline19 score on a scale
/u/ Control ConditionSelf-report 1: Voice Handicap Index (VHI)3 months follow-up11 score on a scale
/u/ Control ConditionSelf-report 1: Voice Handicap Index (VHI)1 month13 score on a scale
/u/ Control ConditionSelf-report 1: Voice Handicap Index (VHI)baseline13 score on a scale
/u/ Control ConditionSelf-report 1: Voice Handicap Index (VHI)1 month follow-up9 score on a scale
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.

Time frame: baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-up

ArmMeasureGroupValue (MEAN)
Straw Phonation in AirSelf-report 2: Vocal Tract Discomfort Scale (VTDS)baseline16 score on a scale
Straw Phonation in AirSelf-report 2: Vocal Tract Discomfort Scale (VTDS)1 month13 score on a scale
Straw Phonation in AirSelf-report 2: Vocal Tract Discomfort Scale (VTDS)1 month follow-up13 score on a scale
Straw Phonation in AirSelf-report 2: Vocal Tract Discomfort Scale (VTDS)3 months follow-up13 score on a scale
Straw Phonation in 2 cm WaterSelf-report 2: Vocal Tract Discomfort Scale (VTDS)1 month19 score on a scale
Straw Phonation in 2 cm WaterSelf-report 2: Vocal Tract Discomfort Scale (VTDS)1 month follow-up16 score on a scale
Straw Phonation in 2 cm WaterSelf-report 2: Vocal Tract Discomfort Scale (VTDS)3 months follow-up18 score on a scale
Straw Phonation in 2 cm WaterSelf-report 2: Vocal Tract Discomfort Scale (VTDS)baseline21 score on a scale
Straw Phonation in 5 cm WaterSelf-report 2: Vocal Tract Discomfort Scale (VTDS)1 month follow-up19 score on a scale
Straw Phonation in 5 cm WaterSelf-report 2: Vocal Tract Discomfort Scale (VTDS)1 month21 score on a scale
Straw Phonation in 5 cm WaterSelf-report 2: Vocal Tract Discomfort Scale (VTDS)3 months follow-up20 score on a scale
Straw Phonation in 5 cm WaterSelf-report 2: Vocal Tract Discomfort Scale (VTDS)baseline25 score on a scale
/u/ Control ConditionSelf-report 2: Vocal Tract Discomfort Scale (VTDS)3 months follow-up12 score on a scale
/u/ Control ConditionSelf-report 2: Vocal Tract Discomfort Scale (VTDS)1 month16 score on a scale
/u/ Control ConditionSelf-report 2: Vocal Tract Discomfort Scale (VTDS)baseline16 score on a scale
/u/ Control ConditionSelf-report 2: Vocal Tract Discomfort Scale (VTDS)1 month follow-up21 score on a scale
Secondary

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

ArmMeasureGroupValue (MEAN)
Straw Phonation in AirSelf-report 3: Vocal Fatigue Index (VFI)baseline14 score on a scale
Straw Phonation in AirSelf-report 3: Vocal Fatigue Index (VFI)1 month11 score on a scale
Straw Phonation in AirSelf-report 3: Vocal Fatigue Index (VFI)1 month follow-up11 score on a scale
Straw Phonation in AirSelf-report 3: Vocal Fatigue Index (VFI)3 months follow-up13 score on a scale
Straw Phonation in 2 cm WaterSelf-report 3: Vocal Fatigue Index (VFI)1 month14 score on a scale
Straw Phonation in 2 cm WaterSelf-report 3: Vocal Fatigue Index (VFI)1 month follow-up12 score on a scale
Straw Phonation in 2 cm WaterSelf-report 3: Vocal Fatigue Index (VFI)3 months follow-up17 score on a scale
Straw Phonation in 2 cm WaterSelf-report 3: Vocal Fatigue Index (VFI)baseline20 score on a scale
Straw Phonation in 5 cm WaterSelf-report 3: Vocal Fatigue Index (VFI)1 month follow-up17 score on a scale
Straw Phonation in 5 cm WaterSelf-report 3: Vocal Fatigue Index (VFI)1 month16 score on a scale
Straw Phonation in 5 cm WaterSelf-report 3: Vocal Fatigue Index (VFI)3 months follow-up19 score on a scale
Straw Phonation in 5 cm WaterSelf-report 3: Vocal Fatigue Index (VFI)baseline19 score on a scale
/u/ Control ConditionSelf-report 3: Vocal Fatigue Index (VFI)3 months follow-up15 score on a scale
/u/ Control ConditionSelf-report 3: Vocal Fatigue Index (VFI)1 month15 score on a scale
/u/ Control ConditionSelf-report 3: Vocal Fatigue Index (VFI)baseline15 score on a scale
/u/ Control ConditionSelf-report 3: Vocal Fatigue Index (VFI)1 month follow-up14 score on a scale
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.

Time frame: baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-up

ArmMeasureGroupValue (MEAN)
Straw Phonation in AirVoice Quality Index 1: Dysphonia Severity Index (DSI)Baseline1.0 score on a scale
Straw Phonation in AirVoice Quality Index 1: Dysphonia Severity Index (DSI)1 month (immediately after the intervention)1.7 score on a scale
Straw Phonation in AirVoice Quality Index 1: Dysphonia Severity Index (DSI)1 month follow-up2.4 score on a scale
Straw Phonation in AirVoice Quality Index 1: Dysphonia Severity Index (DSI)3 months follow-up2.3 score on a scale
Straw Phonation in 2 cm WaterVoice Quality Index 1: Dysphonia Severity Index (DSI)1 month (immediately after the intervention)1.2 score on a scale
Straw Phonation in 2 cm WaterVoice Quality Index 1: Dysphonia Severity Index (DSI)1 month follow-up3.0 score on a scale
Straw Phonation in 2 cm WaterVoice Quality Index 1: Dysphonia Severity Index (DSI)3 months follow-up2.5 score on a scale
Straw Phonation in 2 cm WaterVoice Quality Index 1: Dysphonia Severity Index (DSI)Baseline1.3 score on a scale
Straw Phonation in 5 cm WaterVoice Quality Index 1: Dysphonia Severity Index (DSI)1 month follow-up2.3 score on a scale
Straw Phonation in 5 cm WaterVoice Quality Index 1: Dysphonia Severity Index (DSI)1 month (immediately after the intervention)0.9 score on a scale
Straw Phonation in 5 cm WaterVoice Quality Index 1: Dysphonia Severity Index (DSI)3 months follow-up1.9 score on a scale
Straw Phonation in 5 cm WaterVoice Quality Index 1: Dysphonia Severity Index (DSI)Baseline0.7 score on a scale
/u/ Control ConditionVoice Quality Index 1: Dysphonia Severity Index (DSI)3 months follow-up1.5 score on a scale
/u/ Control ConditionVoice Quality Index 1: Dysphonia Severity Index (DSI)1 month (immediately after the intervention)0.9 score on a scale
/u/ Control ConditionVoice Quality Index 1: Dysphonia Severity Index (DSI)Baseline1.0 score on a scale
/u/ Control ConditionVoice Quality Index 1: Dysphonia Severity Index (DSI)1 month follow-up1.3 score on a scale
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.

Time frame: baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-up

ArmMeasureGroupValue (MEAN)
Straw Phonation in AirVoice Quality Index 2: Acoustic Voice Quality Index (AVQI)1 month3.86 score on a scale
Straw Phonation in AirVoice Quality Index 2: Acoustic Voice Quality Index (AVQI)1 month follow-up3.64 score on a scale
Straw Phonation in AirVoice Quality Index 2: Acoustic Voice Quality Index (AVQI)3 months follow-up3.84 score on a scale
Straw Phonation in AirVoice Quality Index 2: Acoustic Voice Quality Index (AVQI)baseline3.63 score on a scale
Straw Phonation in 2 cm WaterVoice Quality Index 2: Acoustic Voice Quality Index (AVQI)baseline3.69 score on a scale
Straw Phonation in 2 cm WaterVoice Quality Index 2: Acoustic Voice Quality Index (AVQI)1 month follow-up3.22 score on a scale
Straw Phonation in 2 cm WaterVoice Quality Index 2: Acoustic Voice Quality Index (AVQI)3 months follow-up3.22 score on a scale
Straw Phonation in 2 cm WaterVoice Quality Index 2: Acoustic Voice Quality Index (AVQI)1 month3.12 score on a scale
Straw Phonation in 5 cm WaterVoice Quality Index 2: Acoustic Voice Quality Index (AVQI)baseline4.12 score on a scale
Straw Phonation in 5 cm WaterVoice Quality Index 2: Acoustic Voice Quality Index (AVQI)1 month3.73 score on a scale
Straw Phonation in 5 cm WaterVoice Quality Index 2: Acoustic Voice Quality Index (AVQI)3 months follow-up3.86 score on a scale
Straw Phonation in 5 cm WaterVoice Quality Index 2: Acoustic Voice Quality Index (AVQI)1 month follow-up3.74 score on a scale
/u/ Control ConditionVoice Quality Index 2: Acoustic Voice Quality Index (AVQI)1 month follow-up3.57 score on a scale
/u/ Control ConditionVoice Quality Index 2: Acoustic Voice Quality Index (AVQI)3 months follow-up3.15 score on a scale
/u/ Control ConditionVoice Quality Index 2: Acoustic Voice Quality Index (AVQI)1 month3.41 score on a scale
/u/ Control ConditionVoice Quality Index 2: Acoustic Voice Quality Index (AVQI)baseline3.70 score on a scale

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026