NCT07677501

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 21, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 30, 2026

Completed
Last Updated

June 30, 2026

Status Verified

June 1, 2026

Enrollment Period

4 months

First QC Date

June 15, 2026

Last Update Submit

June 28, 2026

Conditions

Keywords

Semi-Occluded Vocal Tract ExercisesSpirometryMaximum Phonation TimeConservatory StudentsBreathing ExercisesVoice TrainingRespiratory Function

Outcome Measures

Primary Outcomes (1)

  • Voice Handicap Index (VHI-10)

    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 Outcomes (1)

  • Maximum Phonation Time (MPT)

    6 weeks

Other Outcomes (4)

  • Forced Vital Capacity (FVC)

    6 weeks

  • Forced Expiratory Volume in 1 Second (FEV₁)

    6 weeks

  • FEV₁/FVC Ratio

    6 weeks

  • +1 more other outcomes

Study Arms (2)

SOVT-Breathing Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

The first measurement was taken in the first week, and the final measurement was taken after 6 weeks and no intervention was applied.

Interventions

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.

SOVT-Breathing Group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, 27000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • ELIF DOKUNLU DINLER, Asst. Prof.

    Hasan Kalyoncu University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

June 15, 2026

First Posted

June 30, 2026

Study Start

July 21, 2025

Primary Completion

November 25, 2025

Study Completion

May 30, 2026

Last Updated

June 30, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations