Clinical trial NCT06137131: Voice Therapy With a Semi-occluded Vocal Tract
Official title: Voice Therapy With a Semi-occluded Vocal Tract: From Current Challenges to Next Level Efficacy Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Voice Disorders
Keywords: voice
semi-occluded vocal tract
larynx
randomized controlled trial
efficacy study
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Research Foundation Flanders
First posted: 2023-11-18
Enrollment: 58
Sex: ALL
Minimum age (years): 17
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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. 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.

Primary outcomes:
measure: (Supra)Glottic Activity: Amplitude of Vibration
timeFrame: baseline (before the intervention)
measure: Supraglottic Activity: Anteroposterior Compression
timeFrame: baseline (before the intervention)
Secondary outcomes:
measure: Voice Quality Index 1: Dysphonia Severity Index (DSI)
timeFrame: baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-up
measure: Voice Quality Index 2: Acoustic Voice Quality Index (AVQI)
timeFrame: baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-up
measure: Self-report 1: Voice Handicap Index (VHI)
timeFrame: baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-up
measure: Self-report 2: Vocal Tract Discomfort Scale (VTDS)
timeFrame: baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-up
measure: Self-report 3: Vocal Fatigue Index (VFI)
timeFrame: baseline (before the intervention), 1 month (immediately after the intervention), 1 month follow-up, 3 months follow-up
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Department of Rehabilitation Sciences, Ghent University (Hospital)
state: East-Flanders
Study officials:
affiliation: University Ghent
name: Kristiane Van Lierde, PhD
role: PRINCIPAL_INVESTIGATOR
References: