- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06712979
Addiction of Lung Volume Recruitment Technique in Lee Silverman Protocol for Voice Professionals (LVRTVOICE)
May 23, 2026 updated by: Vinicius Zacarias Maldaner da silva, Escola Superior de Ciencias da Saude
Comparison Between Lee- Silverman Method and Lung Volume Recruitment Tecnhique in Voice Professionals
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
A cross-over randomized trial with two arms-the Lee Silverman Method and the addiction of lung volume recruitment technique (LVRT)-will be conducted with voice professionals to assess the effects of both interventions on the acoustic, perceptive, and visual aspects of voice and their impact on respiratory muscle strength.
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Janaina P Janaina Pimenta, Msc
- Phone Number: + 55 31994979352
- Email: janaina@espacodavoz.com.br
Study Locations
-
-
Goiás
-
Anápolis, Goiás, Brazil, 700000
- Recruiting
- Unievangelica
-
Contact:
- Janaina P Janaina Pimenta, Msc
- Phone Number: +55 31 99497-3245
- Email: janaina@espacodavoz.com.br
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Voice professionals with no voice disease
Exclusion Criteria:
- smokers
- Glottis paralysis and dysfunction
- dental problems
- Mental and cognitive disorders
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: adapted Lee Silverman Method
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.
|
Exercise protocol with 6 steps that the voice professionals adapted from Lee Silverman Method
|
|
Experimental: Lung volume recruitment Technique - LVRT
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vocal Range Profile
Time Frame: 30 days
|
Minimum fundamental frequency - f0; Maximum f0; Extension f0; Extension in Semitone; Minimum intensity; Maximum intensity and Area
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
functional laryngeal assessment
Time Frame: 30 days
|
The Colton and Casper protocol will assess phonatory function using an endoscopic evaluation with a flexible fiberoptic endoscope.
|
30 days
|
|
Respiratory muscle strength
Time Frame: 30 days
|
Dynamic inspiratory muscle strength (S-index) will be obtained using the KH5 device of the POWERbreathe®.
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 23, 2026
Primary Completion (Actual)
May 23, 2026
Study Completion (Estimated)
July 31, 2026
Study Registration Dates
First Submitted
November 25, 2024
First Submitted That Met QC Criteria
November 30, 2024
First Posted (Actual)
December 3, 2024
Study Record Updates
Last Update Posted (Actual)
May 28, 2026
Last Update Submitted That Met QC Criteria
May 23, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- LVRT VOICE TRAINING
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
a one center trial study without another institution linked with it
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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