"Effects of EMST and Triflo on Voice Parameters and Vocal Fatigue"

NCT07371351 | Not Yet Recruiting

• 1 other identifier: IMU-DKT-EU-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  The study will continue for 4 months from the start of the study.

Study Arms (4)

first experimental group

EXPERIMENTAL

triflo will be applied

Device: Triflo

second experimental groups

EXPERIMENTAL

EMST application will be performed.

Device: EMST

third experimental groups

EXPERIMENTAL

EMST and Triflo applications will be carried out.

Device: Triflo; Device: EMST

control groups

NO INTERVENTION

Interventions

Triflo DEVICE

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.

first experimental group; third experimental groups

EMST DEVICE

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 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

second experimental groups; third experimental groups

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

İstanbul Medipol Üniversitesi- MEDKOM

Istanbul, Beykoz, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Voice Disorders

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• eda Uzuner, phd candidate

  Medipol University

  STUDY DIRECTOR

Central Study Contacts

Eda UZUNER, pdh candidate

CONTACT

+90 5413134023; euzuner@medipol.edu.tr

Seyhun Saime TOPBAŞ, Professor

CONTACT

+90 532 732 46 84; sstopbas@medipol.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: 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.

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 27, 2026
• Study Start: January 10, 2026
• Primary Completion: April 30, 2026
• Study Completion (Estimated): May 10, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)