Voice Therapy With a Semi-occluded Vocal Tract

Sponsor

University Ghent (Other)

Overall Status

Completed

CT.gov ID

NCT06137131

Collaborator

Research Foundation Flanders (Other)

Enrollment

Location

Arms

17.2

Actual Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Voice Disorders	Behavioral: Straw phonation in air Behavioral: straw phonation in water Behavioral: /u/ phonation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 7, 2021

Actual Primary Completion Date :

Mar 14, 2023

Actual Study Completion Date :

Mar 14, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: Straw phonation in air Phonation (/u/ vowel) through a stirring straw (3 mm diameter, 20cm length) in air Other Names: steady SOVT exercise
Experimental: 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.	Behavioral: straw phonation in water 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
Experimental: 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.	Behavioral: straw phonation in water 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
Active Comparator: /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.	Behavioral: /u/ phonation /u/ phonation without a straw, control condition Other Names: articulatory/steady SOVT exercise

Outcome Measures

Primary Outcome Measures

(supra)glottic activity [baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-up]
Laryngeal function determined with the VALI form (Poburka et al., 2017)

Secondary Outcome Measures

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]
DSI: A higher index indicates a better voice quality.
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]
AVQI: A lower index indicates a better voice quality.
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]
VHI: A lower index indicates less impact of the voice impairment on the quality of life.
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]
VTDS: A lower index indicates less discomfort in the vocal tract.
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]
VFI: A lower index indicates less vocal fatigue.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.