- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07677501
Combined SOVT and Respiratory Exercises: Effects on MPT and Respiratory Function
June 28, 2026 updated by: Rukiye Gülcan ANDEROĞLU, Hasan Kalyoncu University
Effects of Combined Semi-Occluded Vocal Tract (SOVT) and Respiratory Exercises on Maximum Phonation Time (MPT) and Respiratory Function in Conservatory Students Across Different Academic Years
This study aims to investigate the effects of combined SOVT and breathing exercises, administered twice weekly for six weeks to conservatory students, through a randomized controlled trial.
The study has two hypotheses: H1: Combined SOVT and breathing exercises increase the maximum phonation duration.
H2: Combined SOVT and breathing exercises improve spirometric parameters (FEV₁, FVC, FEV₁/FVC, and PEF).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study aims to investigate the effects of combined SOVT and breathing exercises, applied twice a week for 6 weeks, on conservatory students at Gaziantep University through a randomized controlled trial.
The study has two hypotheses: H1: Combined SOVT and breathing exercises increase maximum phonation duration.
H2: Combined SOVT and breathing exercises improve spirometric parameters (FEV₁, FVC, FEV₁/FVC, and PEF).
In the intervention group, phonation exercises using a pipette were taught and practiced as part of the SOVT exercise.
Simultaneously, pursed-lip breathing, segmental breathing, and diaphragmatic breathing exercises were taught and practiced as breathing exercises.
At the end of 6 weeks, the maximum phonation duration of all participants was measured with a stopwatch.
Additionally, spirometric parameters were measured using a spirometer.
Study Type
Interventional
Enrollment (Actual)
91
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 Locations
-
-
-
Gaziantep, Turkey (Türkiye), 27000
- Hasan Kalyoncu University
-
-
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:
Being between 18 and 35 years of age
- Being an undergraduate student studying vocal training at a state conservatory
- Volunteering to actively participate in the research process and signing the written consent form
Exclusion Criteria:
• Having been diagnosed with any voice disorder (e.g., nodule, polyp, laryngitis, dysphonia, etc.)
- Having received voice therapy, voice surgery, or respiratory physiotherapy in the past
- Having an acute or chronic respiratory disease (e.g., asthma, COPD, bronchitis)
- Participants who have had an upper respiratory tract infection in the last two weeks
- Participants with a neurological, psychiatric, or cardiopulmonary system diagnosis
- Participants who declare that they cannot regularly attend the exercise protocol
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: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SOVT-Breathing Group
The exercises, which included combined sovt and breathing exercises, were performed twice a week for 6 weeks.
The first measurement was taken in the first week, and the final measurement was taken after 6 weeks.
|
The intervention group underwent combined sovt and breathing exercises.
Sovt exercises consisted of phonation exercises using a pipette.
Breathing exercises consisted of pursed-lip breathing, segmental breathing, and diaphragmatic breathing exercises.
|
|
No Intervention: Control Group
The first measurement was taken in the first week, and the final measurement was taken after 6 weeks and no intervention was applied.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Voice Handicap Index (VHI-10)
Time Frame: 6 weeks
|
The Voice Handicap Index (VHI) will be used to assess participants' self-perceived voice-related handicap.
The questionnaire consists of items evaluating the functional, physical, and emotional impact of voice problems.
Total scores range from 0 to 40, with higher scores indicating greater perceived voice handicap.
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximum Phonation Time (MPT)
Time Frame: 6 weeks
|
Maximum Phonation Time (MPT) will be assessed by asking participants to sustain the vowel /a/ after a maximal inhalation at a comfortable pitch and loudness.
Three trials will be performed with adequate rest between trials, and the longest duration recorded in seconds will be used for analysis.
|
6 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Forced Vital Capacity (FVC)
Time Frame: 6 weeks
|
Forced vital capacity (FVC, L) will be assessed using spirometry according to ATS/ERS recommendations.
Participants will perform at least three acceptable forced expiratory maneuvers, and the highest value in liters will be recorded for analysis.
|
6 weeks
|
|
Forced Expiratory Volume in 1 Second (FEV₁)
Time Frame: 6 weeks
|
Forced expiratory volume in one second (FEV₁, L) will be assessed using spirometry according to ATS/ERS recommendations.
The highest value obtained from at least three acceptable maneuvers will be used for analysis.
|
6 weeks
|
|
FEV₁/FVC Ratio
Time Frame: 6 weeks
|
The FEV₁/FVC ratio (%) will be calculated from spirometric measurements obtained according to ATS/ERS recommendations.
The highest acceptable values will be used for analysis.
|
6 weeks
|
|
Peak Expiratory Flow (PEF)
Time Frame: 6 weeks
|
Peak expiratory flow (PEF, L/min) will be assessed using spirometry according to ATS/ERS recommendations.
The highest value obtained from at least three acceptable maneuvers will be recorded for analysis.
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: ELIF DOKUNLU DINLER, Asst. Prof., Hasan Kalyoncu University
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)
July 21, 2025
Primary Completion (Actual)
November 25, 2025
Study Completion (Actual)
May 30, 2026
Study Registration Dates
First Submitted
June 15, 2026
First Submitted That Met QC Criteria
June 28, 2026
First Posted (Actual)
June 30, 2026
Study Record Updates
Last Update Posted (Actual)
June 30, 2026
Last Update Submitted That Met QC Criteria
June 28, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HasanKU-FTR-RGA-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
Clinical Trials on Voice
-
Universidade Federal de PernambucoCoordination for the Improvement of Higher Education PersonnelCompletedVoice Quality | Voice | Voice Range ProfileBrazil
-
Medipol UniversityNot yet recruitingVoice Disorder | Voice Fatigue | Academic Voice Use and Voice Fatigue | Academician's Risk of Developing Voice Disorder | Voice Disorder Prevention in AcademicsTurkey (Türkiye)
-
Universidad Nacional de ColombiaCompleted
-
University GhentRecruitingPrevention of Voice Disorders in Professional Voice Users | Treatment of Functional Voice Disorders in Professional Voice UsersBelgium
-
University of Wisconsin, MadisonUniversity of Iowa; National Institute on Deafness and Other Communication...Recruiting
-
Chulalongkorn UniversityUnknown
-
Nationwide Children's HospitalAgency for Healthcare Research and Quality (AHRQ)Completed
-
Federal University of Health Science of Porto AlegreUnknown
-
Fundacion para la Investigacion Biomedica del Hospital...Instituto de Salud Carlos IIIRecruitingMusic | Cochlear Implant | VoiceSpain
-
Hitit UniversityCompletedIntubation Complication | Voice AlterationTurkey
Clinical Trials on combined soft and breathing exercises
-
Foundation University IslamabadRecruiting
-
Izmir Bakircay UniversityBezmialem Vakif University; Istanbul Kent UniversityCompletedLymphedema, Breast Cancer | Lymphedema of Upper LimbTurkey
-
Yasmeen Alaa Abd El-Hamied AhmeedCompleted
-
Istanbul University - Cerrahpasa (IUC)Completed
-
Derya AzimCompletedStroke | Physiotherapy and RehabilitationTurkey
-
Uppsala UniversityThe Swedish Research Council; Örebro County CouncilCompleted
-
Indonesia UniversityCompletedBreathing Exercise | Breathing TechniqueIndonesia
-
Federal University of BahiaCompletedParkinson Disease | DysphagiaBrazil
-
Riphah International UniversityCompleted
-
Rawan Mohammed Khairy Mostafa ElsawyCairo UniversityRecruitingChild, Only | Pulmonary Function | Functional Capacity | Thalassemia Major | Incentive SpirometerEgypt