Voice Therapy With a Semi-occluded Vocal Tract

NCT06137131 | Completed Results

• 1 other identifier: 249721N
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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.
2. 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).

Conditions

Voice Disorders

Keywords

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

Outcome Measures

Primary Outcomes (2)

• (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)

Secondary Outcomes (5)

• 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-up

• 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-up

• Self-report 1: Voice Handicap Index (VHI)

  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)

  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)

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

Study Arms (4)

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.

Behavioral: Straw phonation in air

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.

Behavioral: straw phonation in water

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.

Behavioral: straw phonation in water

/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.

Behavioral: /u/ phonation

Interventions

Straw phonation in air BEHAVIORAL

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

Also known as: steady SOVT exercise

straw phonation in air

straw phonation in water BEHAVIORAL

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

straw phonation in 2 cm water; straw phonation in 5 cm water

/u/ phonation BEHAVIORAL

/u/ phonation without a straw, control condition

Also known as: articulatory/steady SOVT exercise

/u/ control condition

Eligibility Criteria

• Age: 17 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• Vocally healthy participants:

Sponsors & Collaborators

• University Ghent: lead
• Research Foundation Flanders: collaborator

Study Sites (1)

Department of Rehabilitation Sciences, Ghent University (Hospital)

Ghent, East-Flanders, 9000, Belgium

Location

MeSH Terms

Conditions

Voice Disorders; Laryngeal Diseases

Interventions

Air; Water; Phonation

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Results Point of Contact

• Title: Dr. Iris Meerschman
• Organization: Ghent University

iris.meerschman@ugent.be

+32499294636

Study Officials

• Kristiane Van Lierde, PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: November 18, 2023
• Study Start: October 7, 2021
• Primary Completion: March 14, 2023
• Study Completion: March 14, 2023
• Last Updated: October 30, 2024
• Results First Posted: October 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)