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Completed

NCT Number: NCT06137131

Voice Therapy With a Semi-occluded Vocal Tract

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.

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Key information

Conditions

Voice Disorders Laryngeal Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms

Age range

17 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Rehabilitation Sciences, Ghent University (Hospital)

Ghent, East-Flanders, 9000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Straw phonation in air

Behavioral

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

Other names: steady SOVT exercise

straw phonation in water

Behavioral

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

Other names: water-resistance therapy, fluctuating SOVT exercise

/u/ phonation

Behavioral

/u/ phonation without a straw, control condition

Other names: articulatory/steady SOVT exercise

Primary outcomes

  1. (Supra)Glottic Activity: Amplitude of Vibration

    Time frame: 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.

  2. Supraglottic Activity: Anteroposterior Compression

    Time frame: 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.

Secondary outcomes

  1. Voice Quality Index 1: Dysphonia Severity Index (DSI)

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

    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.

  2. Voice Quality Index 2: Acoustic Voice Quality Index (AVQI)

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

    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.

  3. Self-report 1: Voice Handicap Index (VHI)

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

    VHI: A lower index indicates less impact of the voice impairment on the quality of life. The VHI ranges from 0 to 120.

  4. Self-report 2: Vocal Tract Discomfort Scale (VTDS)

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

    VTDS: A lower index indicates less discomfort in the vocal tract. The index ranges from 0 to 96.

  5. Self-report 3: Vocal Fatigue Index (VFI)

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

    VFI: A lower index indicates less vocal fatigue. The index ranges from 0 to 76.

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Collaborators

  • Research Foundation Flanders

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 18, 2023
Registry last updated
Oct 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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