Voice FatigueNCT07371351
"Effects of EMST and Triflo on Voice Parameters and Vocal Fatigue"
A study testing Triflo and EMST in people with Voice Fatigue and Voice Disorder, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
A healthy voice is essential for meeting professional and communicative demands, particularly for professional voice users such as academics, who are at increased risk of voice disorders due to prolonged and intensive voice use, unfavorable acoustic conditions, and stress. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Voice Fatigue, Voice Disorder, Academic Voice Use and Voice Fatigue
- What is being tested?
- Triflo and EMST
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2026to 10 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Having taught for at least 2 academic semesters as an academic. Having taught at least 9 hours of face-to-face classes per week. Not having been diagnosed with an organic voice disorder. Not smoking. Not being in a menstrual cycle during the pre-, mid- and post-tests.
Who cannot join
- Being Pregnancy, hypertension disease have a history of stroke, heart anomaly disease chronic asthma disease emphysema or obstructive pulmonary disease, have a any surgery in the skull base and neck region, have a any neurogenic or psychological diagnosis or condition.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
İstanbul Medipol Üniversitesi- MEDKOM
Istanbul, Beykoz
Eda UZUNER, phd candidate, 0216 681 1500 ext. 1890, medkom@medipol.edu.tr
About this study
Official title: The Effect of EMST and Triflo Devices on Acoustic and Aerodynamic Parameters of Sound and Sound Fatigue in Academics: A Randomized Controlled Study
A healthy voice is essential for meeting professional and communicative demands, particularly for professional voice users such as academics, who are at increased risk of voice disorders due to prolonged and intensive voice use, unfavorable acoustic conditions, and stress. Voice disorders often result from inadequate respiratory support, leading to compensatory laryngeal overuse, vocal fatigue, and deterioration in voice quality. Although traditional voice therapy emphasizes diaphragmatic breathing, it does not enhance respiratory capacity because it lacks resistance. This study aims to investigate the effects of resistance-based breathing exercises using the Expiratory Muscle Strength Trainer (EMST 150) and triflo devices on respiratory capacity, acoustic and aerodynamic voice parameters, and vocal fatigue in academics. The findings are expected to contribute to the literature and support the use of EMST as a preventive and therapeutic approach for occupational groups at risk of voice disorders.
Read the detailed description
A healthy voice should provide information about a person's age, gender, and emotional state, while also meeting their professional, social, and communicative needs. A voice disorder is generally a change in voice quality, pitch, and/or loudness that differs from what is expected for someone of the same age or gender. In the presence of a voice disorder, the voice does not represent the speaker and cannot meet their professional, social, and communicative needs. There are many risk factors that cause voice disorders. One of these is occupation.
Speaking excessively long and loudly or at a high pitch due to one's profession is defined as voice misuse and can cause voice disorders. For example, members of professions that require intensive and prolonged use of their voices (teachers, imams, academics, telephone operators, lawyers, theater actors) are more likely to experience voice disorders. Individuals who use their voices as a primary means of communication while performing their professions are defined as professional voice users.
Although professional voice users from different occupational groups may seem to fall under the same heading, they differ in various aspects such as the frequency and method of voice use. This differentiation was classified into four levels of voice by Koufman and Isaacson (1991), and academics were included in the category of professional voice users. Voice disorders are seen in 10% of the general population and 50% of professional voice users. Despite this, there is an insufficient number of studies examining the prevalence of voice disorders in academics, risk factors, and research aimed at evaluating, diagnosing, and preventing observed voice disorders.
Professional voice users have to use their voices more effectively and intensely due to their intensive voice use, and this leads to a need for a stronger and healthier voice compared to other individuals. Risk factors that cause voice disorders in teachers, such as speaking loudly for long periods, noisy and acoustically poor working environments, dry and dusty air, and stress, also apply to academics.
In professions with high voice demands, such as teaching and academia, in addition to reducing or eliminating voice-related problems, preventive intervention programs should be implemented, and the voice should be strengthened to make it resistant to long-term and intensive use. Voice enhancement and long-term use are highly related to respiration, a component of the voice production mechanism.
Respiration, in addition to ventilating the body, provides the exhaled airflow that forms the basis of all voice and speech production. Two aspects of respiration that directly affect voice production are breath support and breath control. Breath support refers to the stabilization of body structures to create adequate air pressure and airflow; breath control refers to how an individual regulates and coordinates airflow for all activities, including speech. Difficulty in establishing and/or maintaining breath support and breath control, such as difficulties in inhaling and/or exhaling air or obtaining sufficient air, can negatively affect voice production. For example, if the respiratory system cannot provide sufficient breath support for voice production, the laryngeal system may overcompensate, leading to voice fatigue, tissue changes in the vocal cords, and changes in voice quality.
Therefore, respiratory support plays an important role in the prevention and rehabilitation of voice disorders. However, changing an individual's type of respiration (clavicular, chest, diaphragmatic) and capacity is not easy or quick. Current voice therapy approaches necessarily include breathing, but they are based on teaching diaphragmatic breathing. Teaching diaphragmatic breathing allows individuals to utilize their existing respiratory capacity, but the absence of resistance does not increase respiratory capacity. This study aims to improve the respiratory capacity and voice quality of academics who require long-term voice production, while reducing vocal fatigue, using an EMST device that enables breathing exercises against resistance. To this end, breathing exercises will be performed using the Expiratory Muscle Strength Trainer (EMST 150) and triflo devices, which allow for pressure adjustment. The application of the EMST device in academics at risk of voice disorders and the results will provide data for the literature. If the study shows an increase in acoustic voice quality, aerodynamic parameters, and exhaled volume, and a decrease in vocal fatigue, the EMST device can be included in therapy for occupational groups with or at risk of voice disorders.
- Conditions
- Voice Fatigue, Voice Disorder, Academic Voice Use and Voice Fatigue, Academician's Risk of Developing Voice Disorder, Voice Disorder Prevention in Academics
- Being tested
- Triflo, EMST
- Keywords
- Voice Disorders, Vocal Fatigue, Professional Voice Users, Respiratory Muscle Training, Acoustic Analysis
- Medical subject headings
- Voice Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrifloDevice
The TriFlo Breathing Exercise Device is scientifically designed to assist in performing breathing exercises that may be prescribed by doctors. This device increases participants' breath volume. Participants hold the device upright by its plastic parts and try to lift the balls upwards while inhaling. Alternatively, participants can invert the device by holding the plastic parts (the balls will fall down) and try to lift the balls upwards while exhaling. Participants will be asked to perform this exercise 5 days a week, 4 hours a day, in 3 sets of 10 exhalations and 10 inhalations.
EMSTDevice
EMST is a rehabilitation approach that uses a device to increase and activate the maximum pressure of the respiratory muscles. These muscles are important for powerful exhalation, coughing, and swallowing. EMST Week 1 Exercise Steps
- The participant is instructed to place the nasal plug on their nasal bone. b. The participant is asked to take a deep breath and not exhale.
- The participant is instructed to place the mouthpiece behind their teeth, inside their mouth, and press their lips firmly against the mouthpiece, pressing down on the sides of their cheeks if necessary.
- Participants are instructed to exhale forcefully and quickly, using their chest and abdominal muscles to push the air through the device. This exhalation effort should only take a few seconds for the air to pass.
- Participants are instructed to rest for at least 15-30 seconds, and to rest between breaths as well. The muscles need time to prepare for the next set.
- Participants repeat this exercise 5 times
| Study group | Role | What they receive |
|---|---|---|
| first experimental group | Experimental | triflo will be applied Receives: Device: Triflo |
| second experimental groups | Experimental | EMST application will be performed. Receives: Device: EMST |
| third experimental groups | Experimental | EMST and Triflo applications will be carried out. Receives: Device: Triflo; Device: EMST |
| control groups | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of vocal fatigue
To assess vocal fatigue, participants will complete a vocal fatigue scale before starting the exercises. Participants will fill out this scale themselves. They will rate the parameters related to vocal fatigue on a scale of 0 to 4. Higher scores indicate greater fatigue. The validity and reliability of the vocal fatigue scale have been established in Turkish. Participants will be asked to complete this scale again in the 3rd week of the exercises and again in the 5th week, which is the final week of the exercises. They will also be asked to complete it again 2 months after the completion of the exercises for follow-up.
Measured: The study will continue for 4 months from the start of the study.
measurement of acoustic parameters of voice
In acoustic measurement, participants will have their measurements taken before starting the exercises.For acoustic parameters of the voice, jitter, shimmer, noise-harmonic ratio, and harmonic-noise ratio parameters will be measured by recording via the Multi-Dimensional Voice Program (MDVP). Furthermore, for acoustic parameters of the voice, the extra smooth cepstral peak prominence value and the Acoustic Voice Quality Index (AVQI) score will be calculated using Praat. These measurements will be repeated 3 weeks after the start of exercises, 5 weeks after the completion of exercises, and 2 months after the completion of exercises during follow-up.
Measured: The study will continue for 4 months from the start of the study.
Aerodynamic measurement of the voice,
For the aerodynamic measurement of voice, participants will be asked to produce the sounds /s/ (measuring lung capacity), /z/ (vocal cord closure time), and /a/ (average sound production time), and the duration will be recorded. An s/z ratio close to 1 or between 1 and 1.3 is considered normal. For /a/ phonation, a normal adult is expected to produce sounds of 27-28 seconds. Participants' values will be recorded before the exercise, at the 3rd week of exercise, at the 5th week after the exercise, and again at 2 months post-exercise for follow-up.
Measured: The study will continue for 4 months from the start of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start10 Jan 2026 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion10 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Voice FatigueStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- 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
- Model description
- Randomized controlled trial. This is a randomized controlled trial. The study will consist of two groups: Group 1 will receive only EMST, Group 2 will receive both EMST and Triflo, Group 3 will receive Triflo, and Group 4 will be the control group.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eda Uzuner, Medipol University
- Investigators
- eda Uzuner, phd candidate, Study director, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371351
- Sponsor's protocol ID
- IMU-DKT-EU-01
- Status last verified
- Jan 2026
- First submitted
- 23 Dec 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of EMST and Triflo Devices on Acoustic and Aerodynamic Parameters of Sound and Sound Fatigue in Academics: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07371351
- Acronym / sponsor ID
- IMU-DKT-EU-01
- Conditions
- Voice Fatigue, Voice Disorder, Academic Voice Use and Voice Fatigue, Academician's Risk of Developing Voice Disorder, Voice Disorder Prevention in Academics
- Keywords
- Voice Disorders, Vocal Fatigue, Professional Voice Users, Respiratory Muscle Training, Acoustic Analysis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 10 Jan 2026 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 10 May 2026 (estimated)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A healthy voice is essential for meeting professional and communicative demands, particularly for professional voice users such as academics, who are at increased risk of voice disorders due to prolonged and intensive voice use, unfavorable acoustic conditions, and stress. Voice disorders often result from inadequate respiratory support, leading to compensatory laryngeal overuse, vocal fatigue, and deterioration in voice quality. Although traditional voice therapy emphasizes diaphragmatic breathing, it does not enhance respiratory capacity because it lacks resistance. This study aims to investigate the effects of resistance-based breathing exercises using the Expiratory Muscle Strength Trainer (EMST 150) and triflo devices on respiratory capacity, acoustic and aerodynamic voice parameters, and vocal fatigue in academics. The findings are expected to contribute to the literature and support the use of EMST as a preventive and therapeutic approach for occupational groups at risk of voice disorders.
Detailed description
A healthy voice should provide information about a person's age, gender, and emotional state, while also meeting their professional, social, and communicative needs. A voice disorder is generally a change in voice quality, pitch, and/or loudness that differs from what is expected for someone of the same age or gender. In the presence of a voice disorder, the voice does not represent the speaker and cannot meet their professional, social, and communicative needs. There are many risk factors that cause voice disorders. One of these is occupation.
Speaking excessively long and loudly or at a high pitch due to one's profession is defined as voice misuse and can cause voice disorders. For example, members of professions that require intensive and prolonged use of their voices (teachers, imams, academics, telephone operators, lawyers, theater actors) are more likely to experience voice disorders. Individuals who use their voices as a primary means of communication while performing their professions are defined as professional voice users.
Although professional voice users from different occupational groups may seem to fall under the same heading, they differ in various aspects such as the frequency and method of voice use. This differentiation was classified into four levels of voice by Koufman and Isaacson (1991), and academics were included in the category of professional voice users. Voice disorders are seen in 10% of the general population and 50% of professional voice users. Despite this, there is an insufficient number of studies examining the prevalence of voice disorders in academics, risk factors, and research aimed at evaluating, diagnosing, and preventing observed voice disorders.
Professional voice users have to use their voices more effectively and intensely due to their intensive voice use, and this leads to a need for a stronger and healthier voice compared to other individuals. Risk factors that cause voice disorders in teachers, such as speaking loudly for long periods, noisy and acoustically poor working environments, dry and dusty air, and stress, also apply to academics.
In professions with high voice demands, such as teaching and academia, in addition to reducing or eliminating voice-related problems, preventive intervention programs should be implemented, and the voice should be strengthened to make it resistant to long-term and intensive use. Voice enhancement and long-term use are highly related to respiration, a component of the voice production mechanism.
Respiration, in addition to ventilating the body, provides the exhaled airflow that forms the basis of all voice and speech production. Two aspects of respiration that directly affect voice production are breath support and breath control. Breath support refers to the stabilization of body structures to create adequate air pressure and airflow; breath control refers to how an individual regulates and coordinates airflow for all activities, including speech. Difficulty in establishing and/or maintaining breath support and breath control, such as difficulties in inhaling and/or exhaling air or obtaining sufficient air, can negatively affect voice production. For example, if the respiratory system cannot provide sufficient breath support for voice production, the laryngeal system may overcompensate, leading to voice fatigue, tissue changes in the vocal cords, and changes in voice quality.
Therefore, respiratory support plays an important role in the prevention and rehabilitation of voice disorders. However, changing an individual's type of respiration (clavicular, chest, diaphragmatic) and capacity is not easy or quick. Current voice therapy approaches necessarily include breathing, but they are based on teaching diaphragmatic breathing. Teaching diaphragmatic breathing allows individuals to utilize their existing respiratory capacity, but the absence of resistance does not increase respiratory capacity. This study aims to improve the respiratory capacity and voice quality of academics who require long-term voice production, while reducing vocal fatigue, using an EMST device that enables breathing exercises against resistance. To this end, breathing exercises will be performed using the Expiratory Muscle Strength Trainer (EMST 150) and triflo devices, which allow for pressure adjustment. The application of the EMST device in academics at risk of voice disorders and the results will provide data for the literature. If the study shows an increase in acoustic voice quality, aerodynamic parameters, and exhaled volume, and a decrease in vocal fatigue, the EMST device can be included in therapy for occupational groups with or at risk of voice disorders.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Randomized controlled trial. This is a randomized controlled trial. The study will consist of two groups: Group 1 will receive only EMST, Group 2 will receive both EMST and Triflo, Group 3 will receive Triflo, and Group 4 will be the control group.
| Arm | Type | Receives |
|---|---|---|
| first experimental group | Experimental | Device: Triflotriflo will be applied |
| second experimental groups | Experimental | Device: EMSTEMST application will be performed. |
| third experimental groups | Experimental | Device: Triflo, Device: EMSTEMST and Triflo applications will be carried out. |
| control groups | No intervention | – |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Having taught for at least 2 academic semesters as an academic. Having taught at least 9 hours of face-to-face classes per week. Not having been diagnosed with an organic voice disorder. Not smoking. Not being in a menstrual cycle during the pre-, mid- and post-tests.
Key exclusion criteria (1 listed)
- Being Pregnancy, hypertension disease have a history of stroke, heart anomaly disease chronic asthma disease emphysema or obstructive pulmonary disease, have a any surgery in the skull base and neck region, have a any neurogenic or psychological diagnosis or condition.
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 |
|---|---|---|
| TrifloThe TriFlo Breathing Exercise Device is scientifically designed to assist in performing breathing exercises that may be prescribed by doctors. This device increases participants' breath volume. Participants hold the device upright by its plastic parts and try to lift the balls upwards while inhaling. Alternatively, participants can invert the device by holding the plastic parts (the balls will fall down) and try to lift the balls upwards while exhaling. Participants will be asked to perform this exercise 5 days a week, 4 hours a day, in 3 sets of 10 exhalations and 10 inhalations. | Device | first experimental group, third experimental groups |
| EMSTEMST is a rehabilitation approach that uses a device to increase and activate the maximum pressure of the respiratory muscles. These muscles are important for powerful exhalation, coughing, and swallowing. EMST Week 1 Exercise Steps a. The participant is instructed to place the nasal plug on their nasal bone. b. The participant is asked to take a deep breath and not exhale. c. The participant is instructed to place the mouthpiece behind their teeth, inside their mouth, and press their lips firmly against the mouthpiece, pressing down on the sides of their cheeks if necessary. d. Participants are instructed to exhale forcefully and quickly, using their chest and abdominal muscles to push the air through the device. This exhalation effort should only take a few seconds for the air to pass. e. Participants are instructed to rest for at least 15-30 seconds, and to rest between breaths as well. The muscles need time to prepare for the next set. f. Participants repeat this exercise 5 times | Device | second experimental groups, third experimental groups |
Primary outcome
Measurement of vocal fatigue
Time frame: The study will continue for 4 months from the start of the study.
To assess vocal fatigue, participants will complete a vocal fatigue scale before starting the exercises. Participants will fill out this scale themselves. They will rate the parameters related to vocal fatigue on a scale of 0 to 4. Higher scores indicate greater fatigue. The validity and reliability of the vocal fatigue scale have been established in Turkish. Participants will be asked to complete this scale again in the 3rd week of the exercises and again in the 5th week, which is the final week of the exercises. They will also be asked to complete it again 2 months after the completion of the exercises for follow-up.
measurement of acoustic parameters of voice
Time frame: The study will continue for 4 months from the start of the study.
In acoustic measurement, participants will have their measurements taken before starting the exercises.For acoustic parameters of the voice, jitter, shimmer, noise-harmonic ratio, and harmonic-noise ratio parameters will be measured by recording via the Multi-Dimensional Voice Program (MDVP). Furthermore, for acoustic parameters of the voice, the extra smooth cepstral peak prominence value and the Acoustic Voice Quality Index (AVQI) score will be calculated using Praat. These measurements will be repeated 3 weeks after the start of exercises, 5 weeks after the completion of exercises, and 2 months after the completion of exercises during follow-up.
Aerodynamic measurement of the voice,
Time frame: The study will continue for 4 months from the start of the study.
For the aerodynamic measurement of voice, participants will be asked to produce the sounds /s/ (measuring lung capacity), /z/ (vocal cord closure time), and /a/ (average sound production time), and the duration will be recorded. An s/z ratio close to 1 or between 1 and 1.3 is considered normal. For /a/ phonation, a normal adult is expected to produce sounds of 27-28 seconds. Participants' values will be recorded before the exercise, at the 3rd week of exercise, at the 5th week after the exercise, and again at 2 months post-exercise for follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No
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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.
eda Uzuner, phd candidate study director
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triflo and EMST in people with Voice Fatigue and Voice Disorder, run by Medipol University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 27 Jan 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eda UZUNER, pdh candidate (+90 5413134023 ext. 0216 681 1890, euzuner@medipol.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of vocal fatigue (time frame: The study will continue for 4 months from the start of the study.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2026.