- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07677501
Combined SOVT and Respiratory Exercises: Effects on MPT and Respiratory Function
28. juni 2026 opdateret af: 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).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
91
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Gaziantep, Tyrkiet (Türkiye), 27000
- Hasan Kalyoncu University
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ja
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
|
|
Ingen indgriben: 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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Voice Handicap Index (VHI-10)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Maximum Phonation Time (MPT)
Tidsramme: 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.
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6 weeks
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Forced Vital Capacity (FVC)
Tidsramme: 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
|
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Forced Expiratory Volume in 1 Second (FEV₁)
Tidsramme: 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.
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6 weeks
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FEV₁/FVC Ratio
Tidsramme: 6 weeks
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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.
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6 weeks
|
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Peak Expiratory Flow (PEF)
Tidsramme: 6 weeks
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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.
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6 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: ELIF DOKUNLU DINLER, Asst. Prof., Hasan Kalyoncu University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
21. juli 2025
Primær færdiggørelse (Faktiske)
25. november 2025
Studieafslutning (Faktiske)
30. maj 2026
Datoer for studieregistrering
Først indsendt
15. juni 2026
Først indsendt, der opfyldte QC-kriterier
28. juni 2026
Først opslået (Faktiske)
30. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
30. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HasanKU-FTR-RGA-01
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