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Efficacy of Flow Ball Phonation in Professional Voice Users

NCT06960772 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2025-05-07

No results posted yet for this study

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.

Conditions

  • Prevention of Voice Disorders in Professional Voice Users
  • Treatment of Functional Voice Disorders in Professional Voice Users

Interventions

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.

Sponsors & Collaborators

  • University Ghent

    lead OTHER

Principal Investigators

  • Evelien D'haeseleer · University Ghent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-08
Primary Completion
2027-12-31
Completion
2028-09-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06960772 on ClinicalTrials.gov