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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
91

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: combined soft and breathing exercises
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hasan Kalyoncu University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 21, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 25, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 30, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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