Voice Therapy With a Semi-occluded Vocal Tract

Voice Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06137131
• Other study ID #: 249721N
• Status: Completed
• Phase: N/A
• Start date: October 7, 2021
• Est. completion date: March 14, 2023

Study information

• Verified date: November 2023
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 14, 2023
• Est. primary completion date: March 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Patients:

Inclusion criteria are aged between 18 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 criteraia are aged between 18 and 50 years. Exclusion criteria dagnosed with dysphonia, previous or current participation in voice therapy, previous phonosurgical interventions, pregnancy, smoking, nasal or ear diseases, and neurological disorders.

Related Conditions & MeSH terms

• Voice Disorders

Intervention

Behavioral:
• Straw phonation in air
Phonation (/u/ vowel) through a stirring straw (3 mm diameter, 20cm length) in air
• straw phonation in water
Phonation (/u/ vowel) through a stirring straw (3 mm diameter, 20cm length) in 2 cm or 5 cm water
• /u/ phonation
/u/ phonation without a straw, control condition

Locations

Country	Name	City	State
Belgium	Department of Rehabilitation Sciences, Ghent University (Hospital)	Ghent	East-Flanders

Sponsors (2)

Lead Sponsor	Collaborator
University Ghent	Research Foundation Flanders

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(supra)glottic activity	Laryngeal function determined with the VALI form (Poburka et al., 2017)	baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-up
Secondary	voice quality index 1: Dysphonia Severity Index (DSI)	DSI: A higher index indicates a better voice quality.	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)	AVQI: A lower index indicates a better voice quality.	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.	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.	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.	baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-up