NCT07129668

Brief Summary

This clinical trial aimed to evaluate the effects of the semi-occluded vocal tract exercise Finger Kazoo (FK), with and without oropharyngeal expansion, on the singing voice. Fifteen classically trained singers, screened using the Singing Voice Handicap Index-10 (SVHI-10), participated in a randomized, single-blind, crossover trial with two experimental sessions separated by 48 hours. Participants were randomized via Sealed Envelope to start in Condition A (without oropharyngeal expansion) or Condition B (with oropharyngeal expansion). In each session, standardized recordings were obtained before and after the intervention, including maximum phonation time for the vowels /a/ and /i/, and an operatic aria excerpt. Acoustic analysis (PRAAT) extracted fundamental frequency (F0), jitter, and shimmer. Comparisons between baseline and experimental conditions were performed using paired-samples t-tests, Wilcoxon tests, robust paired t-tests, and Friedman ANOVA with Durbin-Conover, Tukey, Bonferroni, and Holm post hoc corrections, with a 95% confidence interval. Auditory-perceptual evaluation was conducted by 15 blinded experts using the EAI Scale Form, with balanced sample distribution among raters. Self-perceptual evaluation was also performed by participants using the same scale.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 30, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2025

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2025

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 19, 2025

Completed
Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

2 months

First QC Date

August 11, 2025

Last Update Submit

August 15, 2025

Conditions

Keywords

Singing VoiceFinger KazooSOVTEOperatic Voice

Outcome Measures

Primary Outcomes (1)

  • Maximum Phonation Time (MPT) variation between conditions without and with oropharyngeal enlargement.

    Assessment of the difference in maximum phonation time (in seconds) between two experimental conditions: without oropharyngeal enlargement (Condition A) and with oropharyngeal enlargement (Condition B), during sustained vowel phonation. Data Collection Method: Acoustic recordings obtained using Praat software. The MPT was measured from the onset of phonation to cessation, with participants instructed to sustain the vowel at comfortable pitch and loudness. Analysis Method: Robust Paired Samples T-Test comparing MPT between Condition A and Condition B. Effect sizes calculated using Cohen's d. Results Summary: Mean MPT was significantly higher in Condition B (+7.9 s; p \< .001; d = 0.46), indicating improved phonatory efficiency.

    Baseline and 48 hours after first session (allowing return to baseline before second session).

Secondary Outcomes (1)

  • Change in Fundamental Frequency Stability (ΔF0) between conditions without and with oropharyngeal enlargement.

    Baseline and 48 hours after first session (allowing return to baseline before second session).

Other Outcomes (2)

  • Change in Jitter between conditions without and with oropharyngeal enlargement.

    Baseline and 48 hours after first session (allowing return to baseline before second session).

  • Change in Shimmer between conditions without and with oropharyngeal enlargement.

    Baseline and 48 hours after first session (allowing return to baseline before second session).

Study Arms (3)

Condition A

ACTIVE COMPARATOR

Without Oropharyngeal Enlargement

Behavioral: Condition ABehavioral: Condition B

Condition B

ACTIVE COMPARATOR

With Oropharyngeal Enlargement

Behavioral: Condition ABehavioral: Condition B

Condition 0 or Baseline

ACTIVE COMPARATOR

Condition 0 (Baseline) consists of producing the target vocal tasks without any semi-occlusion or intentional oropharyngeal modification just a pre vocal warmup.

Behavioral: Condition ABehavioral: Condition B

Interventions

Condition ABEHAVIORAL

Condition A consists of performing the Finger Kazoo exercise without inducing oropharyngeal enlargement. In this condition, participants place the index finger vertically in front of the lips to partially occlude the vocal tract, producing a semi-occluded vocal tract configuration, but without modifying tongue position, soft palate height, or pharyngeal wall expansion to increase the oropharyngeal space.

Also known as: Whitout Oropharyngeal Enlargement
Condition 0 or BaselineCondition ACondition B
Condition BBEHAVIORAL

Condition B consists of performing the Finger Kazoo exercise with intentional oropharyngeal enlargement. In this condition, participants place the index finger vertically in front of the lips to partially occlude the vocal tract, producing a semi-occluded vocal tract configuration, while simultaneously modifying tongue position, elevating the soft palate, and expanding the pharyngeal walls to increase the oropharyngeal space.

Also known as: With Oropharyngeal Enlargement
Condition 0 or BaselineCondition ACondition B

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Classically trained singers aged 18 to 45 years.
  • Scoring below the cutoff for vocal handicap on the Singing Voice Handicap Index-10 (SVHI-10 ≤ 6 )\*.
  • No history of recently vocal fold pathology or laryngeal surgery.
  • Non-smokers and no current upper respiratory infection.
  • Willingness and ability to attend two experimental sessions spaced 48 hours apart.

You may not qualify if:

  • Presence of any current voice disorder or history of chronic laryngeal disease.
  • Recent respiratory infection within 2 weeks prior to enrollment.
  • Use of medications affecting voice or respiratory function.
  • Inability or unwillingness to comply with study protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Essua - University of Aveiro

Aveiro, Aveiro District, 3810-193, Portugal

Location

MeSH Terms

Conditions

Dysphonia

Condition Hierarchy (Ancestors)

Voice DisordersLaryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: Fifteen classically trained singers participated in a randomized, single-blind, crossover trial with two experimental sessions separated by 48 hours. Participants were allocated via Sealed Envelope randomization to start in Condition A (without oropharyngeal expansion) or Condition B (with oropharyngeal expansion). In each session, standardised recordings were obtained before and after the intervention, including maximum phonation time for the vowels /a/ and /i/, and an operatic aria excerpt.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 11, 2025

First Posted

August 19, 2025

Study Start

May 30, 2025

Primary Completion

July 24, 2025

Study Completion

July 26, 2025

Last Updated

August 19, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to institutional and legal restrictions on data privacy and protection as per the data protection agreement signed with the University of Aveiro.

Locations