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The proposed research will investigate the most effective strategy to reduce vocal exertion reported by speakers in noisy environments. Repeated vocal exertion can lead to voice problems and therefore identifying effective strategies can lead to better prevention of acquired voice disorders. This study will compare the effects of vocal rest and controlled phonation both before and after vocal exertion. The investigators hypothesize that vocal rest and controlled phonation will mitigate the negative effects of vocal exertion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Adults | Experimental | Participants will complete vocal rest and controlled phonation |
|
| Healthy Adults reporting Vocal Fatigue | Experimental | Participants will complete vocal rest and controlled phonation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vocal rest and Controlled Phonation | Behavioral | Voice rest and semi occluded vocal tract voice exercises |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phonation Threshold Pressure | Minimum air pressure required to initiate and sustain vocal fold oscillation | 2.5 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Lung Volume Excursion | The difference between lung volume initiation and termination on connected speech | 2.5 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Preeti Sivasankar | Purdue University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Purdue University | West Lafayette | Indiana | 47906 | United States |
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Of 37 enrolled participants, 31 were assigned to study groups based on self-reported vocal fatigue level.
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Adults | Participants will complete vocal rest and controlled phonation Vocal rest and Controlled Phonation: Voice rest and semi occluded vocal tract voice exercises |
| FG001 | Healthy Adults Reporting Vocal Fatigue | Participants will complete vocal rest and controlled phonation Vocal rest and Controlled Phonation: Voice rest and semi occluded vocal tract voice exercises |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Adults | Participants will complete vocal rest and controlled phonation Vocal rest and Controlled Phonation: Voice rest and semi occluded vocal tract voice exercises |
| BG001 | Healthy Adults Reporting Vocal Fatigue |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Phonation Threshold Pressure | Minimum air pressure required to initiate and sustain vocal fold oscillation | Posted | Mean | Standard Deviation | cmH20 | 2.5 hours |
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Participants were monitored for adverse events from the time consent was obtained until approximately 24 hours following study completion.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Adults | Participants will complete vocal rest and controlled phonation Vocal rest and Controlled Phonation: Voice rest and semi occluded vocal tract voice exercises |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Preeti Sivasankar | Purdue University | 765-494-3788 | preeti@purdue.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 22, 2020 | Jun 24, 2021 | Prot_SAP_000.pdf |
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Within Subject Design
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Participants will complete vocal rest and controlled phonation
Vocal rest and Controlled Phonation: Voice rest and semi occluded vocal tract voice exercises
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Vocal Fatigue Index | The Vocal Fatigue Index measures self-reported vocal fatigue symptoms. The scale is divided into three separately scored sections (two of which were used here). Possible scores range from 0 to 44 on Part 1, and 0 - 20 on part 2. Scores >24 on part 1, or >7 on part 2 are indicative of vocal fatigue.Scores below this range are considered normal. | Median | Full Range | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Lung Volume Excursion | The difference between lung volume initiation and termination on connected speech | Posted | Mean | Standard Deviation | % Vital Capacity | 2.5 hours |
|
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Healthy Adults Reporting Vocal Fatigue | Participants will complete vocal rest and controlled phonation Vocal rest and Controlled Phonation: Voice rest and semi occluded vocal tract voice exercises | 0 | 10 | 0 | 10 | 0 | 10 |
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| Post Restoration Strategy |
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