Healthy
Conditions
Brief summary
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.
Interventions
BEHAVIORALVocal rest and Controlled Phonation
Voice rest and semi occluded vocal tract voice exercises
Sponsors
Purdue University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Within Subject Design
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* within age range
Exclusion criteria
* Voice Disorders * Strong gag reflex * Craniofacial disorders * Cognitive Impairments * Head and Neck Cancer * Hearing Difficulties * Dentition problems that prevent an oral scope being placed in mouth
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phonation Threshold Pressure | 2.5 hours | Minimum air pressure required to initiate and sustain vocal fold oscillation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lung Volume Excursion | 2.5 hours | The difference between lung volume initiation and termination on connected speech |
Countries
United States
Participant flow
Pre-assignment details
Of 37 enrolled participants, 31 were assigned to study groups based on self-reported vocal fatigue level.
Participants by arm
| Arm | Count |
|---|---|
| Healthy Adults Participants will complete vocal rest and controlled phonation
Vocal rest and Controlled Phonation: Voice rest and semi occluded vocal tract voice exercises | 21 |
| 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 | 10 |
| Total | 31 |
Baseline characteristics
| Characteristic | Healthy Adults | Total | Healthy Adults Reporting Vocal Fatigue |
|---|---|---|---|
| Age, Categorical <=18 years | 4 Participants | 8 Participants | 4 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 23 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 30 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 21 Participants | 6 Participants |
| Region of Enrollment United States | 21 participants | 31 participants | 10 participants |
| Sex: Female, Male Female | 11 Participants | 15 Participants | 4 Participants |
| Sex: Female, Male Male | 10 Participants | 16 Participants | 6 Participants |
| Vocal Fatigue Index Vocal Fatigue Index Part 1 | 4 units on a scale | 4 units on a scale | 24 units on a scale |
| Vocal Fatigue Index Vocal Fatigue Index Part 2 | 0 units on a scale | 2 units on a scale | 3.5 units on a scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 10 |
| other Total, other adverse events | 0 / 21 | 0 / 10 |
| serious Total, serious adverse events | 0 / 21 | 0 / 10 |
Outcome results
Primary
Phonation Threshold Pressure
Minimum air pressure required to initiate and sustain vocal fold oscillation
Time frame: 2.5 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Adults | Phonation Threshold Pressure | Pre-Exertion | 5.41 cmH20 | Standard Deviation 1.26 |
| Healthy Adults | Phonation Threshold Pressure | Post-Exertion | 6.39 cmH20 | Standard Deviation 1.8 |
| Healthy Adults | Phonation Threshold Pressure | Post Restoration Strategy | 5.63 cmH20 | Standard Deviation 1.32 |
| Healthy Adults Reporting Vocal Fatigue | Phonation Threshold Pressure | Pre-Exertion | 5.08 cmH20 | Standard Deviation 1.59 |
| Healthy Adults Reporting Vocal Fatigue | Phonation Threshold Pressure | Post-Exertion | 6.33 cmH20 | Standard Deviation 1.4 |
| Healthy Adults Reporting Vocal Fatigue | Phonation Threshold Pressure | Post Restoration Strategy | 5.61 cmH20 | Standard Deviation 1.59 |
p-value: <0.001Mixed Models Analysis
Secondary
Lung Volume Excursion
The difference between lung volume initiation and termination on connected speech
Time frame: 2.5 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Adults | Lung Volume Excursion | Baseline | 13.5 % Vital Capacity | Standard Deviation 7.2 |
| Healthy Adults | Lung Volume Excursion | Post Exertion | 21.6 % Vital Capacity | Standard Deviation 10.6 |
| Healthy Adults | Lung Volume Excursion | Post Restoration Strategy | 18.7 % Vital Capacity | Standard Deviation 11.5 |
| Healthy Adults Reporting Vocal Fatigue | Lung Volume Excursion | Baseline | 14.5 % Vital Capacity | Standard Deviation 6.4 |
| Healthy Adults Reporting Vocal Fatigue | Lung Volume Excursion | Post Exertion | 12.9 % Vital Capacity | Standard Deviation 6.5 |
| Healthy Adults Reporting Vocal Fatigue | Lung Volume Excursion | Post Restoration Strategy | 18.4 % Vital Capacity | Standard Deviation 7.15 |
p-value: <0.01Mixed Models Analysis