Efficacy of Flow Ball Phonation in Professional Voice Users

NCT06960772 | Recruiting DMC

• 1 other identifier: ONZ-2025-0017
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Flow Ball; SOVTE; professional voice users; Straw Phonation

Outcome Measures

Primary Outcomes (5)

• Flexible Strobovideolaryngoscopy

  Laryngeal function determined with the Voice-Vibratory Assessment with Laryngeal Imaging (VALI) rating form (Poburka et al., 2017).

  baseline (before the intervention) and 3 weeks (immediately after the intervention)

• Dysphonia Severity Index (DSI)

  DSI: A higher index indicates a better voice quality. The index ranges from -5 to +5 for severely dysphonic to normal voices. A more negative index indicates a worse voice quality. Values \> +5 are possible in subjects with excellent vocal capacities. A DSI = +1.6 is the threshold separating normophonic from dysphonic persons.

  baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up

• Acoustic Voice Quality Index (AVQI)

  A lower AVQI indicates a better voice quality. The index ranges from 0 to 10 for normal to severely dysphonic voices. An AVQI of 2.95 is the threshold separating normophonic from dysphonic persons.

  baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up

• Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)

  The CAPE-V will be used to provide an auditory-perceptual evaluation of the voice quality. This visual analogue scale will examine the voice based on the parameters grade, roughness, breathiness, asthenia, strain, instability, pitch and loudness.

  baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up

• Voice Handicap Index

  VHI: A lower index indicates less impact of the voice impairment on the quality of life. The VHI ranges from 0 to 120.

  baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up

Secondary Outcomes (10)

• Maximum phonation time (MPT)

  baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up

• Fundamental frequency (fo)

  baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up

• Jitter

  baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up

• Shimmer

  baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up

• Noise to Harmonics Ratio (NHR)

  baseline (twice before the intervention), 3 weeks (immediately after the intervention), 3 weeks follow-up, 3 months follow-up

Study Arms (3)

Flow Ball

EXPERIMENTAL

Behavioral: Flow Ball Intervention

Straw Phonation

EXPERIMENTAL

Behavioral: Straw Phonation Intervention

Sham Intervention

SHAM COMPARATOR

Behavioral: Sham Intervention

Interventions

Flow Ball Intervention BEHAVIORAL

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'

Flow Ball

Straw Phonation Intervention BEHAVIORAL

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'

Straw Phonation

Sham Intervention BEHAVIORAL

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.

Sham Intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All genders
• All ethnicities
• years
• Diagnosis of a functional voice disorder
• Professional voice users

You may not qualify if:

• Diagnosis of an organic voice disorder
• Current participation in voice therapy
• Previous phonosurgical interventions
• Pregnancy
• Smoking
• Nasal or ear diseases
• Neurological disorders
• OBJECTIVE 2: PREVENTION
• All genders
• All ethnicities
• years
• Professional voice users
• Current or previous diagnosis of a voice disorder
• Current or previous participation in voice therapy
• Previous phonosurgical interventions

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Ghent University

Ghent, East-Flanders, 9000, Belgium

RECRUITING

Study Officials

• Evelien D'haeseleer

  University Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Casey Dewanckele

CONTACT

+32491547192; casey.dewanckele@ugent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 7, 2025
• Study Start: May 8, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): September 30, 2028
• Last Updated: May 7, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)