Efficacy of Flow Ball Phonation in Professional Voice Users
NCT ID: NCT06960772
Last Updated: 2025-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
144 participants
INTERVENTIONAL
2025-05-08
2028-09-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Flow Ball
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'
Straw Phonation
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'
Sham Intervention
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.
Interventions
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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'
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'
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.
Eligibility Criteria
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Inclusion Criteria
* All ethnicities
* 18 - 60 years
* Diagnosis of a functional voice disorder
* Professional voice users
* All genders
* All ethnicities
* 18 - 60 years
* Professional voice users
Exclusion Criteria
* Current participation in voice therapy
* Previous phonosurgical interventions
* Pregnancy
* Smoking
* Nasal or ear diseases
* Neurological disorders
OBJECTIVE 2: PREVENTION
* Current or previous diagnosis of a voice disorder
* Current or previous participation in voice therapy
* Previous phonosurgical interventions
* Pregnancy
* Smoking
* Nasal or ear diseases
* Neurological disorders
18 Years
60 Years
ALL
Yes
Sponsors
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University Ghent
OTHER
Responsible Party
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Principal Investigators
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Evelien D'haeseleer
Role: PRINCIPAL_INVESTIGATOR
University Ghent
Locations
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Ghent University
Ghent, East-Flanders, Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ONZ-2025-0017
Identifier Type: -
Identifier Source: org_study_id
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