Adults 6 to 12, any sex, with Voice Disorders in Children or Vocal Nodules in Children. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Dysphonia Severity IndexPrimary· pre: one day before therapy, day 0; post: immediately after last therapy session, day 4
The dysphonia severity index (DSI) is a multiparametric score to quantify vocal capabilities. It is based on a weighted combination of 4 voice parameters: maximum phonation time (MPT, s), highest frequency (F-high, Hz), lowest intensity (I-low, dB) and jitter (%). The DSI is constructed as 0.13 MPT + 0.0053 F-high - 0.26 I-low - 1.18 jitter +12.4. The index ranges from -5 to +5. A score above +1.6 is considered normal. A higher score corresponds with better voice quality / vocal capacities.
Group
Value
95% CI
Experimental Group 1 - Straw Phonation
1.8
0.1 – 3.4
Experimental Group 2 - Resonant Voice Therapy
1.8
0.1 – 3.4
Control Group
0.0
-1.9 – 1.9
Change in Acoustic Voice Quality IndexPrimary· pre: one day before therapy, day 0; post: immediately after last therapy session, day 4
The acoustic voice quality index (AVQI) is a multiparametric score to quantify vocal quality. It is based on a weighted combination of 6 voice parameters: smoothed cepstral peak prominence (CPPS), harmonics-to-noise ratio (HNR), shimmer local (SL), shimmer local dB (SLdB), general slope of the spectrum (slope) and tilt of the regression line through the spectrum (tilt). The formula is constructed as 9.072 - 0.245 × CPPs - 0.161 × HNR - 0.470 × SL + 6.158 × SLdB - 0.071 × Slope - 0.170 × Tilt and ranges from 0 to 10. A lower score correlates with a better vocal quality.
Group
Value
95% CI
Experimental Group 1 - Straw Phonation
-0.1
-0.6 – 0.4
Experimental Group 2 - Resonant Voice Therapy
-0.4
-1.1 – 0.3
Control Group
-0.3
-0.9 – 0.3
Change in Pediatric Voice Handicap Index (pVHI)Primary· pre: one day before therapy, day 0; post: immediately after last therapy session, day 4
The pediatric voice handicap index (pVHI) is a questionnaire to investigate children's voice-related quality of life, completed by the parents. The index ranges from 0 to 92. A higher score correlates with more psychosocial impact of the voice disorder.
Group
Value
95% CI
Experimental Group 1 - Straw Phonation
-3.3
-7.2 – 0.7
Experimental Group 2 - Resonant Voice Therapy
-3.9
-8.3 – 0.4
Control Group
-1.7
-6.7 – 3.2
Change in Overall Severity From Consensus Auditory-Perceptual Evaluation of VoicePrimary· pre: one day before therapy, day 0; post: immediately after last therapy session, day 4
This tool is designed to describe the severity of dysphonia by rating six parameters (overall severity, roughness, breathiness, strain, pitch, and loudness) on a visual-analog scale from 0 to 100, where 0 is considered within normal limits. A higher score corresponds with worse voice quality.
Group
Value
95% CI
Experimental Group 1 - Straw Phonation
-6.5
-12.2 – -0.9
Experimental Group 2 - Resonant Voice Therapy
-0.7
-6.4 – 4.9
Control Group
-1.0
-7.7 – 5.7
Sponsor's own description
The goal of this clinical trial is to determine and compare the effects of different voice therapy programs in children with vocal fold nodules. Vocal fold nodules are non-cancerous growths on the vocal folds which cause hoarseness. The main questions this trial aims to answer are:
* What are the short-term effects of the new voice therapy program 'straw phonation' and a more traditional 'resonant voice therapy' program on (a) the vocal quality, (b) the size of the growths on the vocal folds, and (c) the overall functioning in children with vocal fold nodules? During straw phonation exercises, you make sound through a drinking straw. During resonant voice therapy exercises or 'humming', you make an 'm' sound as you breathe out.
* What are the long-term effects of these voice therapy programs?
Participants will receive a short-term intensive voice therapy program of four days. The researchers will compare the straw phonation group, resonant voice therapy group and control group to see if voice therapy works well in treating children with vocal fold nodules.
The researchers hypothesize that straw phonation will have better results than resonant voice therapy. Straw phonation exercises are easier for children because they use an external tool (the straw) and less self-correction is needed.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by University Hospital, Ghent
Last refreshed: 10 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05878197.