Trials / Recruiting

RecruitingNCT06960772

Efficacy of Flow Ball Phonation in Professional Voice Users

Status: Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 144 (estimated)

Sponsor: University Ghent · Academic / Other
Sex: All
Age: 18 Years – 60 Years
Healthy volunteers: Accepted

Summary

The aim of this study is to investigate the effects of flow ball phonation on the voice of professional voice users and elite vocal performers, both with and without functional voice disorders. Given the substantial vocal demands inherent to this population and their reliance on the voice for occupational purposes, this intervention may represent a valuable approach for the prevention and/or treatment voice disorders.

Detailed description

Background. Due to the high vocal demands, professional voice users (e.g. teachers) and elite vocal performers (e.g. singers) are risk populations for developing voice disorders. High-quality voice research in these vulnerable populations is highly needed for effective and efficient treatment and prevention of voice disorders. The flow ball (FB) is a promising innovative voice therapy device to perform semi-occluded vocal tract exercises (SOVTE) with the extra advantage of providing real-time visual feedback of the airflow. Despite this important advantage, strong efficacy studies of an FB intervention program are lacking. Objective. To investigate the immediate-, short- and long-term effects of an SOVTE intervention with the FB on the phonation of professional voice users with (treatment) and without (prevention) voice disorders and to compare it with the 'treatment as usual' straw phonation (SP) and a sham condition, using a longitudinal randomized sham-controlled trial (RCT). Methods. Subjects will be randomly assigned into an FB group, an SP group or a control (sham) group. They will receive a short-term intensive voice intervention of 3 weeks, combining both guided therapy/training sessions and independent practice at home. A flexible strobovideolaryngoscopy and a multidimensional voice assessment will be performed by assessors blinded to group allocation and study phase. Assessments will be performed two times before the intervention (pre 1 and pre 2), immediately after the intensive intervention (post 1) and at 3 weeks (follow-up 1) and 3 months (follow-up 2) follow-up. The sham group will use the same FB device but no phonation will be involved.

Conditions

Interventions

Type	Name	Description
BEHAVIORAL	Flow Ball Intervention	Participants receive an intensive intervention using the Flow Ball device over 3 weeks (a total of 5 hours), consisting of weekly: * 1 in-person guided session of 30 minutes * 2 guided online sessions of 15 minutes each (via teleconsult) * On the remaining 4 days of the week, participants perform independent training at home: 5 minutes, twice daily. This training is recorded using the app 'MyMedicoach'
BEHAVIORAL	Straw Phonation Intervention	Participants receive an intensive intervention using a straw over 3 weeks (a total of 5 hours), consisting of weekly: * 1 in-person guided session of 30 minutes * 2 guided online sessions of 15 minutes each (via teleconsult) * On the remaining 4 days of the week, participants perform independent training at home: 5 minutes, twice daily. This training is recorded using the app 'MyMedicoach'
BEHAVIORAL	Sham Intervention	Participants receive an intensive intervention over 3 weeks (a total of 5 hours), consisting of weekly: * 1 in-person guided session of 30 minutes * 2 guided online sessions of 15 minutes each (via teleconsult) * On the remaining 4 days of the week, participants perform independent training at home: 5 minutes, twice daily. This training is recorded using the app 'MyMedicoach' The sham intervention uses breathing exercises through the Flow Ball, no phonation will be involved.

Timeline

Start date: 2025-05-08
Primary completion: 2027-12-31
Completion: 2028-09-30
First posted: 2025-05-07
Last updated: 2025-05-07

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT06960772. Inclusion in this directory is not an endorsement.