Voice DisordersNCT02102399
Vocal Warm-up and Respiratory Muscle Training
A study testing Vocal Warm-up and Respiratory Muscle Training in people with Voice Disorders, run by Federal University of Bahia at 1 site in Brazil.
Trial summary
The purpose of this study is to verify the effects of two speech-pathology interventions: vocal warm-up and respiratory training in teachers who work in a public school of the city of Salvador-Bahia, with or without complaints of vocal disorders. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Voice Disorders
- What is being tested?
- Vocal Warm-up and Respiratory Muscle Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2013to Sep 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 20-60.
- No occurence of speech therapy simultaneously to the intervention
Who cannot join
- Professional voice use in another activity;
- Frequent use of alcohol and tobacco;
- Influenza and/or upper respiratory tract infections (eg, rhinitis, sinusitis, pharyngitis) during the period of participation in the research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vocal Warm-up and Respiratory Training in Teachers: a Randomized Clinical Trial
The purpose of this study is to verify the effects of two speech-pathology interventions: vocal warm-up and respiratory training in teachers who work in a public school of the city of Salvador-Bahia, with or without complaints of vocal disorders. It is a preventive study and the hypothesis is that both approaches can produce positive voice changes, but the Vocal Warm-up will produce the most significant changes.
Read the detailed description
Randomized Clinical Trial where participants were allocated into groups: Vocal Warm-up (to perform exercises of resistance and flexibility for 13 minutes before teaching, during six weeks) and Respiratory Muscle Training (to perform exercises to strengthen the respiratory muscles through the use of incentive respiratory equipment. Five repetitions of exhales with an interval of thirty seconds between each one were performed. It was requested rest for two minutes, repeating the procedure four times with the total of five series. These exercises were performed for 13 minutes before teaching, during six weeks).
Outcomes analyzed: demographics and teaching activity characteristics; symptoms, habits and factors associated with voice disorders; self-reported voice handicap (Voice Handicap Index-VHI-10); vocal severity rating (Vocal Severity Scale); and acoustic parameters through the computerized acoustic voice analysis program VoxMetria (CTS Informatics).
- Conditions
- Voice Disorders
- Being tested
- Vocal Warm-up, Respiratory Muscle Training
- Keywords
- Voice training, Education, Voice, Faculty
- Medical subject headings
- Voice Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vocal Warm-upBehavioural
Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
Respiratory Muscle TrainingBehavioural
Respiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
| Study group | Role | What they receive |
|---|---|---|
| Vocal Warm-up | Experimental | Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day. Receives: Behavioral: Vocal Warm-up |
| Respiratory Muscle Training | Experimental | Respiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day. Receives: Behavioral: Respiratory Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voice Handicap Index (VHI-10)
The voice handicap index (VHI) is a self-assessment questionnaire which quantifies the functional, physical and emotional impacts of a voice disorder on the quality of life. The VHI-10 is a reduced version and it consists of 10 questions about the severity of the voice problem perceived by the subject. It is presented as an ordinal scale (range 0-4) that indicates how frequently the subject has experienced the same situation (0 = never; 1 = almost never; 2 = sometimes; 3= almost always; 4 = always). Total VHI Score ranges from 0 (never) to 40 (always). Higher scores indicate greater voice handicap. Abnormal values > 11.
Measured: Baseline, 6 weeks
Acoustic Analysis (Fundamental Frequency)
The measurement of fundamental frequency directly reflects the rate of vibration of the vocal folds. The fundamental frequency term refers to the frequency of more occurrence of vocal fold vibration, featuring a certain production.
Measured: Baseline, 6 weeks
Acoustic Analysis (Jitter)
Jitter is the perturbation cycle-to-cycle of the fundamental frequency. High levels of jitter are normally associated with pathological voice. The instability of the fundamental frequency can be attributed to changes in size, shape or firmness of the vocal folds.
Normal values must be < 0.6%.
Measured: Baseline, 6 weeks
Acoustic Analysis (Shimmer)
The shimmer measures the amplitude's disturbance, e. g. how fast the amplitude changes on a sustained vowel for a few seconds. Shimmer high levels are normally associated with pathological voice. This can be attributed due to changes in size, shape or firmness of the vocal folds.
Normal values < 6.5%.
Measured: Baseline, 6 weeks
Acoustic Analysis (Noise)
Noise is the analysis of aperiodic components of the sound's signal. It is an important correlate of that the human ear considers voice disorders. Normal levels < 2.5 dB
Measured: Baseline, 6 weeks
Acoustic Analysis (GNE)
Glottal to Noise Excitation ratio (GNE) is an acoustic measurement to calculate the noise in a series of pulses produced by the oscillation of the vocal folds. This parameter is based on the hypothesis that resulting pulses of vocal fold collision generate a synchronous excitation of different frequency bands. Moreover, the noise produced by the vocal folds compressed generates uncorrelated excitations.
Normal levels > 0.5 dB
Measured: Baseline, 6 weeks
Voice Handicap Index (VHI-10) 2
The voice handicap index (VHI) is a self-assessment questionnaire which quantifies the functional, physical and emotional impacts of a voice disorder on the quality of life. The VHI-10 is a reduced version and it consists of 10 questions about the severity of the voice problem perceived by the subject. It is presented as an ordinal scale (range 0-4) that indicates how frequently the subject has experienced the same situation (0 = never; 1 = almost never; 2 = sometimes; 3= almost always; 4 = always). Total VHI Score ranges from 0 (never) to 40 (always). Higher scores indicate greater voice handicap. Abnormal values > 11.
Measured: Baseline, 6 weeks
Acoustic Analysis (Fundamental Frequency) 2
The measurement of fundamental frequency directly reflects the rate of vibration of the vocal folds. The fundamental frequency term refers to the frequency of more occurrence of vocal fold vibration, featuring a certain production.
Measured: Baseline, 6 weeks
Acoustic Analysis (Jitter) 2
Jitter is the perturbation cycle-to-cycle of the fundamental frequency. High levels of jitter are normally associated with pathological voice. The instability of the fundamental frequency can be attributed to changes in size, shape or firmness of the vocal folds.
Normal values must be < 0.6%.
Measured: Baseline, 6 weeks
Acoustic Analysis (Shimmer) 2
The shimmer measures the amplitude's disturbance, e. g. how fast the amplitude changes on a sustained vowel for a few seconds. Shimmer high levels are normally associated with pathological voice. This can be attributed due to changes in size, shape or firmness of the vocal folds.
Normal values < 6.5%.
Measured: Baseline, 6 weeks
Acoustic Analysis (Noise) 2
Noise is the analysis of aperiodic components of the sound's signal. It is an important correlate of that the human ear considers voice disorders. Normal levels < 2.5 dB
Measured: Baseline, 6 weeks
Acoustic Analysis (GNE) 2
Glottal to Noise Excitation ratio (GNE) is an acoustic measurement to calculate the noise in a series of pulses produced by the oscillation of the vocal folds. This parameter is based on the hypothesis that resulting pulses of vocal fold collision generate a synchronous excitation of different frequency bands. Moreover, the noise produced by the vocal folds compressed generates uncorrelated excitations.
Normal levels > 0.5 dB
Measured: Baseline, 6 weeks
Change in Voice Handicap Index (VHI-10)
The voice handicap index (VHI) is a self-assessment questionnaire which quantifies the functional, physical and emotional impacts of a voice disorder on the quality of life. The VHI-10 is a reduced version and it consists of 10 questions about the severity of the voice problem perceived by the subject. It is presented as an ordinal scale (range 0-4) that indicates how frequently the subject has experienced the same situation (0 = never; 1 = almost never; 2 = sometimes; 3= almost always; 4 = always). Total VHI Score ranges from 0 (never) to 40 (always). Higher scores indicate greater voice handicap. Abnormal values > 11.
Measured: Baseline, 6 weeks
Change in Fundamental Frequency
The measurement of fundamental frequency directly reflects the rate of vibration of the vocal folds. The fundamental frequency term refers to the frequency of more occurrence of vocal fold vibration, featuring a certain production.
Measured: Baseline, 6 weeks
Change in Jitter
Jitter is the perturbation cycle-to-cycle of the fundamental frequency. High levels of jitter are normally associated with pathological voice. The instability of the fundamental frequency can be attributed to changes in size, shape or firmness of the vocal folds.
Normal values must be < 0.6%.
Measured: Baseline, 6 weeks
Change in Shimmer
Shimmer measures the amplitude perturbations, e. g. how fast the amplitude changes on a sustained vowel for a few seconds. Shimmer high levels are normally associated with pathological voice. This can be attributed due to changes in size, shape or firmness of the vocal folds. Normal values < 6.5%
Measured: Baseline, 6 weeks
Change in Noise
Noise is the analysis of aperiodic components of the sound's signal. It is an important correlate of that the human ear considers voice disorders. Normal levels < 2.5 dB
Measured: Baseline, 6 weeks
Change in GNE
Glottal to Noise Excitation ratio (GNE) is an acoustic measurement to calculate the noise in a series of pulses produced by the oscillation of the vocal folds. This parameter is based on the hypothesis that resulting pulses of vocal fold collision generate a synchronous excitation of different frequency bands. Moreover, the noise produced by the vocal folds compressed generates uncorrelated excitations.
Normal levels > 0.5 dB
Measured: Baseline, 6 weeks
Secondary outcomes (4)
Post-treatment Questionnaire (Voice Symptoms Improvement)
The post-treatment questionnaire was based on the original designed by Roy (2003) for assessing the teachers' perception of voice improvement and compliance with the intervention. Participants rated their extent of improvement on a 3-point Likert scale ("not at all/somewhat"; "moderate"; "a lot"). The questionnaire was applied only after the intervention. The answers were dichotomized in two categories ("moderate/a lot" and "not at all/somewhat"). The results were presented in frequency/percentage of subjects that answered "moderate/a lot" in each intervention.
Measured: After 6 weeks of intervention
Post-treatment Questionnaire (Voice Clearer)
The post-treatment questionnaire was based on the original designed by Roy (2003) for assessing the teachers' perception of voice improvement and compliance with the intervention. Participants rated their extent of improvement on a 3-point Likert scale ("not at all/somewhat"; "moderate"; "a lot"). The questionnaire was applied only after the intervention. The answers were dichotomized in two categories ("moderate/a lot" and "not at all/somewhat"). The results were presented in frequency/percentage of subjects that answered "moderate/a lot" in each intervention.
Measured: After 6 weeks of intervention
Post-treatment Questionnaire (Easier to Talk)
The post-treatment questionnaire was based on the original designed by Roy (2003) for assessing the teachers' perception of voice improvement and compliance with the intervention. Participants rated their extent of improvement on a 3-point Likert scale ("not at all/somewhat"; "moderate"; "a lot"). The questionnaire was applied only after the intervention. The answers were dichotomized in two categories ("moderate/a lot" and "not at all/somewhat"). The results were presented in frequency/percentage of subjects that answered "moderate/a lot" in each intervention.
Measured: After 6 weeks of intervention
Post-treatment Questionnaire (Compliance With Intervention)
The post-treatment questionnaire was based on the original designed by Roy (2003) for assessing the teachers' perception of voice improvement and compliance with the intervention. Participants rated their degree of compliance on a 3-point Likert scale ("not at all/somewhat"; "moderate"; "a lot"). The questionnaire was applied only after the intervention. The answers were dichotomized in two categories ("moderate/a lot" and "not at all/somewhat"). It was considered compliance the answers "moderate" and "a lot" in comparison of "not at all/somewhat", considered as no compliance. The results were presented in frequency/percentage of subjects in each intervention.
Measured: After 6 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study startJul 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Voice DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Bahia
- Sponsor type
- University, hospital or other
- Collaborators
- Bahia State Secretariat of Education, Brazil
- Responsible party
- Principal investigator, Maria Lucia Vaz Masson, Federal University of Bahia
- Investigators
- Maria Lucia V Masson, PhD, Principal investigator, Federal University of BahiaLilian Paternostro, MS, Study chair, Federal University of BahiaFernando M Carvalho, PhD, Study director, Federal University of Bahia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02102399
- Sponsor's protocol ID
- U1111-1152-9129
- Status last verified
- Sep 2015
- First submitted
- 30 Mar 2014
- Last updated
- 8 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Pereira LP, Masson ML, Carvalho FM. Vocal warm-up and breathing training for teachers: randomized clinical trial. Rev Saude Publica. 2015;49:67. doi: 10.1590/S0034-8910.2015049005716. Epub 2015 Oct 9.
PubMed 26465664
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vocal Warm-up and Respiratory Training in Teachers: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02102399
- Acronym / sponsor ID
- U1111-1152-9129
- Conditions
- Voice Disorders
- Keywords
- Voice training, Education, Voice, Faculty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Federal University of BahiaUniversity, hospital or other
- Collaborators
- Bahia State Secretariat of Education, Brazil
- Study start
- Jul 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 2 Apr 2014 (estimated)
- Results
- Posted 17 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to verify the effects of two speech-pathology interventions: vocal warm-up and respiratory training in teachers who work in a public school of the city of Salvador-Bahia, with or without complaints of vocal disorders. It is a preventive study and the hypothesis is that both approaches can produce positive voice changes, but the Vocal Warm-up will produce the most significant changes.
Detailed description
Randomized Clinical Trial where participants were allocated into groups: Vocal Warm-up (to perform exercises of resistance and flexibility for 13 minutes before teaching, during six weeks) and Respiratory Muscle Training (to perform exercises to strengthen the respiratory muscles through the use of incentive respiratory equipment. Five repetitions of exhales with an interval of thirty seconds between each one were performed. It was requested rest for two minutes, repeating the procedure four times with the total of five series. These exercises were performed for 13 minutes before teaching, during six weeks).
Outcomes analyzed: demographics and teaching activity characteristics; symptoms, habits and factors associated with voice disorders; self-reported voice handicap (Voice Handicap Index-VHI-10); vocal severity rating (Vocal Severity Scale); and acoustic parameters through the computerized acoustic voice analysis program VoxMetria (CTS Informatics).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vocal Warm-up | Experimental | Behavioral: Vocal Warm-upVocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day. |
| Respiratory Muscle Training | Experimental | Behavioral: Respiratory Muscle TrainingRespiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age between 20-60.
- No occurence of speech therapy simultaneously to the intervention
Key exclusion criteria (3 listed)
- Professional voice use in another activity;
- Frequent use of alcohol and tobacco;
- Influenza and/or upper respiratory tract infections (eg, rhinitis, sinusitis, pharyngitis) during the period of participation in the research.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vocal Warm-upVocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day. | Behavioural | Vocal Warm-up |
| Respiratory Muscle TrainingRespiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day. | Behavioural | Respiratory Muscle Training |
Primary outcome
Voice Handicap Index (VHI-10)
Time frame: Baseline, 6 weeks
The voice handicap index (VHI) is a self-assessment questionnaire which quantifies the functional, physical and emotional impacts of a voice disorder on the quality of life. The VHI-10 is a reduced version and it consists of 10 questions about the severity of the voice problem perceived by the subject. It is presented as an ordinal scale (range 0-4) that indicates how frequently the subject has experienced the same situation (0 = never; 1 = almost never; 2 = sometimes; 3= almost always; 4 = always). Total VHI Score ranges from 0 (never) to 40 (always). Higher scores indicate greater voice handicap. Abnormal values > 11.
Acoustic Analysis (Fundamental Frequency)
Time frame: Baseline, 6 weeks
The measurement of fundamental frequency directly reflects the rate of vibration of the vocal folds. The fundamental frequency term refers to the frequency of more occurrence of vocal fold vibration, featuring a certain production.
Acoustic Analysis (Jitter)
Time frame: Baseline, 6 weeks
Jitter is the perturbation cycle-to-cycle of the fundamental frequency. High levels of jitter are normally associated with pathological voice. The instability of the fundamental frequency can be attributed to changes in size, shape or firmness of the vocal folds. Normal values must be < 0.6%.
Acoustic Analysis (Shimmer)
Time frame: Baseline, 6 weeks
The shimmer measures the amplitude's disturbance, e. g. how fast the amplitude changes on a sustained vowel for a few seconds. Shimmer high levels are normally associated with pathological voice. This can be attributed due to changes in size, shape or firmness of the vocal folds. Normal values < 6.5%.
Acoustic Analysis (Noise)
Time frame: Baseline, 6 weeks
Noise is the analysis of aperiodic components of the sound's signal. It is an important correlate of that the human ear considers voice disorders. Normal levels < 2.5 dB
Acoustic Analysis (GNE)
Time frame: Baseline, 6 weeks
Glottal to Noise Excitation ratio (GNE) is an acoustic measurement to calculate the noise in a series of pulses produced by the oscillation of the vocal folds. This parameter is based on the hypothesis that resulting pulses of vocal fold collision generate a synchronous excitation of different frequency bands. Moreover, the noise produced by the vocal folds compressed generates uncorrelated excitations. Normal levels > 0.5 dB
Voice Handicap Index (VHI-10) 2
Time frame: Baseline, 6 weeks
The voice handicap index (VHI) is a self-assessment questionnaire which quantifies the functional, physical and emotional impacts of a voice disorder on the quality of life. The VHI-10 is a reduced version and it consists of 10 questions about the severity of the voice problem perceived by the subject. It is presented as an ordinal scale (range 0-4) that indicates how frequently the subject has experienced the same situation (0 = never; 1 = almost never; 2 = sometimes; 3= almost always; 4 = always). Total VHI Score ranges from 0 (never) to 40 (always). Higher scores indicate greater voice handicap. Abnormal values > 11.
Acoustic Analysis (Fundamental Frequency) 2
Time frame: Baseline, 6 weeks
The measurement of fundamental frequency directly reflects the rate of vibration of the vocal folds. The fundamental frequency term refers to the frequency of more occurrence of vocal fold vibration, featuring a certain production.
Acoustic Analysis (Jitter) 2
Time frame: Baseline, 6 weeks
Jitter is the perturbation cycle-to-cycle of the fundamental frequency. High levels of jitter are normally associated with pathological voice. The instability of the fundamental frequency can be attributed to changes in size, shape or firmness of the vocal folds. Normal values must be < 0.6%.
Acoustic Analysis (Shimmer) 2
Time frame: Baseline, 6 weeks
The shimmer measures the amplitude's disturbance, e. g. how fast the amplitude changes on a sustained vowel for a few seconds. Shimmer high levels are normally associated with pathological voice. This can be attributed due to changes in size, shape or firmness of the vocal folds. Normal values < 6.5%.
Acoustic Analysis (Noise) 2
Time frame: Baseline, 6 weeks
Noise is the analysis of aperiodic components of the sound's signal. It is an important correlate of that the human ear considers voice disorders. Normal levels < 2.5 dB
Acoustic Analysis (GNE) 2
Time frame: Baseline, 6 weeks
Glottal to Noise Excitation ratio (GNE) is an acoustic measurement to calculate the noise in a series of pulses produced by the oscillation of the vocal folds. This parameter is based on the hypothesis that resulting pulses of vocal fold collision generate a synchronous excitation of different frequency bands. Moreover, the noise produced by the vocal folds compressed generates uncorrelated excitations. Normal levels > 0.5 dB
Change in Voice Handicap Index (VHI-10)
Time frame: Baseline, 6 weeks
The voice handicap index (VHI) is a self-assessment questionnaire which quantifies the functional, physical and emotional impacts of a voice disorder on the quality of life. The VHI-10 is a reduced version and it consists of 10 questions about the severity of the voice problem perceived by the subject. It is presented as an ordinal scale (range 0-4) that indicates how frequently the subject has experienced the same situation (0 = never; 1 = almost never; 2 = sometimes; 3= almost always; 4 = always). Total VHI Score ranges from 0 (never) to 40 (always). Higher scores indicate greater voice handicap. Abnormal values > 11.
Change in Fundamental Frequency
Time frame: Baseline, 6 weeks
The measurement of fundamental frequency directly reflects the rate of vibration of the vocal folds. The fundamental frequency term refers to the frequency of more occurrence of vocal fold vibration, featuring a certain production.
Change in Jitter
Time frame: Baseline, 6 weeks
Jitter is the perturbation cycle-to-cycle of the fundamental frequency. High levels of jitter are normally associated with pathological voice. The instability of the fundamental frequency can be attributed to changes in size, shape or firmness of the vocal folds. Normal values must be < 0.6%.
Change in Shimmer
Time frame: Baseline, 6 weeks
Shimmer measures the amplitude perturbations, e. g. how fast the amplitude changes on a sustained vowel for a few seconds. Shimmer high levels are normally associated with pathological voice. This can be attributed due to changes in size, shape or firmness of the vocal folds. Normal values < 6.5%
Change in Noise
Time frame: Baseline, 6 weeks
Noise is the analysis of aperiodic components of the sound's signal. It is an important correlate of that the human ear considers voice disorders. Normal levels < 2.5 dB
Change in GNE
Time frame: Baseline, 6 weeks
Glottal to Noise Excitation ratio (GNE) is an acoustic measurement to calculate the noise in a series of pulses produced by the oscillation of the vocal folds. This parameter is based on the hypothesis that resulting pulses of vocal fold collision generate a synchronous excitation of different frequency bands. Moreover, the noise produced by the vocal folds compressed generates uncorrelated excitations. Normal levels > 0.5 dB
4 secondary outcomes
Post-treatment Questionnaire (Voice Symptoms Improvement)
Time frame: After 6 weeks of intervention
Post-treatment Questionnaire (Voice Clearer)
Time frame: After 6 weeks of intervention
Post-treatment Questionnaire (Easier to Talk)
Time frame: After 6 weeks of intervention
Post-treatment Questionnaire (Compliance With Intervention)
Time frame: After 6 weeks of intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26465664Pereira LP, Masson ML, Carvalho FM. Vocal warm-up and breathing training for teachers: randomized clinical trial. Rev Saude Publica. 2015;49:67. doi: 10.1590/S0034-8910.2015049005716. Epub 2015 Oct 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Lucia V Masson, PhD principal investigator
Federal University of Bahia
Lilian Paternostro, MS study chair
Federal University of Bahia
Fernando M Carvalho, PhD study director
Federal University of Bahia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vocal Warm-up and Respiratory Muscle Training in people with Voice Disorders, run by Federal University of Bahia at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Voice Handicap Index (VHI-10) (time frame: Baseline, 6 weeks). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02102399, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2015.