NCT06712979

Brief Summary

The goal of this clinical trial in voice professionals with both genders aimed to verify the changes in the vocal range profile and the changes in the glottic and vocal tract configuration for more efficient phonation after applying the adapted Lee Silverman Method and the addiction of lung volume recruitment technique in acoustic and structural analysis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

November 25, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 3, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

December 10, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

December 3, 2024

Status Verified

November 1, 2024

Enrollment Period

9 months

First QC Date

November 25, 2024

Last Update Submit

November 30, 2024

Conditions

Keywords

voice trainingacousticrespiratory therapy

Outcome Measures

Primary Outcomes (1)

  • Vocal Range Profile

    Minimum fundamental frequency - f0; Maximum f0; Extension f0; Extension in Semitone; Minimum intensity; Maximum intensity and Area

    30 days

Secondary Outcomes (2)

  • functional laryngeal assessment

    30 days

  • Respiratory muscle strength

    30 days

Study Arms (2)

adapted Lee Silverman Method

ACTIVE COMPARATOR

The individuals will perform the Lee Silverman methods adapted to voice professionals. They will do a 14-day protocol, with three sets of 5 repetitions daily.

Procedure: Adapted Lee Silverman Method

Lung volume recruitment Technique - LVRT

EXPERIMENTAL

In the LVRT intervention, the same exercises as in the adapted LEE Silverman intervention will be performed, however, a bag-mask ventilation system (Lumiar, Brazil) will be attached during the emission with an inflated oro-nasal mask (Lumiar, Brazil) connected to a pressure gauge (Illife device, Brazil) that will monitor the inspiratory pressure level between 30 and 40 cmH2O during phonatory emissions. it will be performed 3 sets with 5 repetitions.

Device: Lung volume recruitment technique - LVRT

Interventions

Exercise protocol with 6 steps that the voice professionals adapted from Lee Silverman Method

adapted Lee Silverman Method

The adapted Lee Silverman Method will have a addiction of LVRT technique. Lung inflation begins, reaching an optimal inspiratory peak of 30 cmH2O. From this point, the sound /HA/ begins to be emitted until the most comfortable low sound, where the emission should be maintained for as long as possible, making sure that this time is not less than 12 seconds, trying to emit a high and comfortable vocal intensity. When performing the emissions, the mouth should be kept wide open with the tongue, jaw and neck relaxed, repeating 5 emissions in 3 series. Between series, the participant will be instructed to drink 50 ml of water exactly as in the previous emissions.

Lung volume recruitment Technique - LVRT

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Voice professionals with no voice disease

You may not qualify if:

  • smokers
  • Glottis paralysis and dysfunction
  • dental problems
  • Mental and cognitive disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unievangelica

Anápolis, Goiás, 700000, Brazil

Location

Central Study Contacts

Janaina P Janaina Pimenta, Msc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcomes assessors will be blinded for intervention applied before the asessment
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: all participants will perform adapted Lee Silverman Method (Adapt Lee) and Lung volume recruitment technique plus Adapt Lee during 2 weeks, with washout period of 6 weeks.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mentor in Human Movement and Rehabilitation

Study Record Dates

First Submitted

November 25, 2024

First Posted

December 3, 2024

Study Start

December 10, 2024

Primary Completion

August 31, 2025

Study Completion

September 30, 2025

Last Updated

December 3, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

a one center trial study without another institution linked with it

Locations