ClinicalTrials.gg
CompletedNCT04486989Updated Nov 18, 2023

Treatment for Teachers With Vocal Fatigue

An interventional study of Cardiovascular Conditioning Protocol and Voice Production Exercises in Vocal Fatigue and Treatment, sponsored by East Tennessee State University. Completed at 1 site in United States. Open to female participants aged 21 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-11-18.

Sponsored by East Tennessee State University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Feb 2020, registered Jul 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Randomized
Ages
21 Years to 60 Years
Sex
Female
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Study summary

Teachers are a population at high risk for voice disorders given their occupational demands. In a teaching career, a common debilitating symptom among all vocal symptoms experienced is - vocal fatigue, impacting teachers' occupational performance and increasing health care costs. It is therefore essential to identify potential treatment options to alleviate the symptom of vocal fatigue. The purpose of this study is to utilize a body-system level cardiovascular training protocol in comparison to traditional voice production training to alleviate the symptoms of vocal fatigue.

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Conditions studied

  • Vocal Fatigue
  • Treatment

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03

In context

Voice Disorders

77 studies on the registry are indexed under Voice Disorders; 17 are open to participants now.

This study's enrollment of 31 is below the median of 41 across 54 interventional studies indexed under Voice Disorders.

Browse Voice Disorders studies →

Lead sponsor

East Tennessee State University is the lead sponsor of 21 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Female teachers between the ages of 21-60 years Female instructors and college professors between the ages of 21-60 years
  • A score of ≥ 15 on factor 1 of the VFI (tiredness and avoidance of voice use) or a score of ≤ 5 on factor 3 of the VFI (improvement of symptoms or lack thereof with rest)
  • Sedentary- wherein participants will need to be completing mild intensity cardiovascular exercise less than 150 minutes in less than 5 days per week

Exclusion criteria

Exclusion Criteria:

  • Trained athletes
  • Trained singers
  • Smoking in the past 6months
  • Prior history of a vocal fold pathology and current vocal fold pathology
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    Cardiovascular Conditioning Protocol

    Participants will complete a sub maximal cardiovascular training program twice per week for a period of 4 weeks.

    Behavioral: Cardiovascular Conditioning Protocol

  • Active comparator
    Voice Production Exercises

    Participants will complete voice production exercises twice per week for a period of 4 weeks.

    Other: Voice Production Exercises

Interventions

  • BehavioralCardiovascular Conditioning Protocol

    Participants will be randomized to either one of the treatment arms to receive treatment for a period of 4 weeks.

  • OtherVoice Production Exercises

    Participants will be randomized to either one of the treatment arms to receive treatment for a period of 4 weeks.

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What researchers measure

Primary outcomes

  1. Changes in Physiologic Cost of Speaking

    Physiologic Cost of Speaking is measured as the rate of oxygen consumption at steady state/ rate of speech (wpm) for each of the two reading tasks

    Time frame: At baseline, at 4 weeks after treatment

  2. Changes in Oxygen Uptake Kinetics

    Oxygen Uptake Kinetics is measured as the pattern of oxygen use during each of the two reading tasks

    Time frame: At baseline, at 4 weeks after treatment

  3. Changes in Post Task Physiological Recovery

    Post Task Physiological Recovery is measured as the time, seconds, to reach baseline of oxygen consumption post task (within 0.2ml/kg/min) following each of the reading tasks

    Time frame: At baseline, at 4 weeks after treatment

  4. Changes in Excess Post Exercise Consumption (EPOC)

    EPOC is measured as the magnitude of recovery oxygen consumption, ml/kg/min for each of the reading tasks

    Time frame: At baseline, at 4 weeks after treatment

  5. Changes in Ratings of Perceived Exertion (RPE)

    Borg Scale of Ratings of Perceived Exertion (RPE)- measures the self-report of vocal effort for each of the reading tasks

    Time frame: At baseline, at 4 weeks after treatment

  6. Changes in Vocal Fatigue Index (VFI)

    Vocal Fatigue Index (VFI) is a retrospective scale that measures self-reported symptoms of vocal fatigue

    Time frame: At baseline, at 4 weeks after treatment

  7. Changes in Global Rating of Vocal Fatigue (VAS 100mm)

    Global Rating of Vocal Fatigue (VAS 100mm) measures the ability to sustain voice with no fatigue at the end of a working day

    Time frame: At baseline, at 4 weeks after treatment

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Study locations

1 site
  • East Tennessee State University
    Johnson City, Tennessee 37614, United States
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References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2020 to primary completion in Mar 2023, 37 months.

Of 30 interventional studies with no phase under Voice Disorders, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 48. This study's 37 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 20, 2020
First posted
Jul 27, 2020
StartActual
Feb 4, 2020
Primary completionActual
Mar 30, 2023
CompletionActual
Jun 6, 2023
Last update
Nov 18, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04486989
Lead sponsor
East Tennessee State University
Responsible party
Chayadevie Nanjundeswaran (Associate Professor, East Tennessee State University) — Principal investigator
First posted
Jul 27, 2020
Start date
Feb 4, 2020
Primary completion
Mar 30, 2023
Completion
Jun 6, 2023
Last update
Nov 18, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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