Interaction of Caffeine and Hydration on Voice
Primary Purpose
Voice Disorders
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
C2 (200mg of caffeine; 1/2 L of water)
C3(200mg of caffeine; 1 L of water)
C1 (200mg of caffeine, no water)
Placebo (no caffeine, no water).
Sponsored by
About this trial
This is an interventional basic science trial for Voice Disorders focused on measuring Voice, aerodynamics, acoustics
Eligibility Criteria
Inclusion Criteria:
- Healthy individuals, ranging from 18 to 35 years of age.
Exclusion Criteria:
- History of voice disorders, history of coronary disease, history of high blood pressure.
Sites / Locations
- Southern Illinois University Carbondale
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Caffeine and hydration.
No caffeine, no hydration.
Arm Description
200 mg of caffeine (over the counter caffeine tablet) 1 liter of water
Outcomes
Primary Outcome Measures
Effect of caffeine and hydration on acoustic measures of voice.
The acoustic measurement of voice include the parameters of relative average perturbation (RAP), shimmer, and sound pressure level (SPL).
Secondary Outcome Measures
Effect of caffeine and hydration on aerodynamic measures of voice. Effect of caffeine and hydration on aerodynamic measures of voice.
The aerodynamic measurement of voice includes the parameter of airflow. Airflow measurements refer to the amount of air passing through the region of the vocal folds decibels.
Full Information
NCT ID
NCT01435837
First Posted
September 24, 2010
Last Updated
June 10, 2013
Sponsor
Southern Illinois University Carbondale
1. Study Identification
Unique Protocol Identification Number
NCT01435837
Brief Title
Interaction of Caffeine and Hydration on Voice
Official Title
Effects of the Interaction of Caffeine and Hydration on Voice Performance
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Southern Illinois University Carbondale
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study, Effects of Interaction of Caffeine and Hydration on Voice Performance, is to gather information about the effects of caffeine and hydration upon voice performance. The research question involves whether systemic hydration may reduce degradation on voice performance caused by caffeine ingestion. It is hypothesized that the hydration conditions will result in a less degraded vocal performance as compared with the nonhydration condition.The investigation involves abstention from any caffeine ingestion for 24 hours - from 8pm the day before testing to 8am the morning of testing. In addition, preparation for participation involves abstaining from ingesting any foods and liquids for 12 hours - from 8pm to 8am of the following morning. Each test will take about 10 minutes.
Detailed Description
The objective of this investigation is to explore the interaction of water and caffeine on voice performance through (a) acoustic measures of voice, and (b) aerodynamic measurements (minimum lung pressure required to initiate phonation. The acoustic and aerodynamic measurements were selected for this study in an effort to demonstrate the effects of four levels of hydration and caffeine status on voice quality: 1) caffeine and water1 (i.e.., Experimental Group 1 - ingestion of 200 mg of caffeine in conjunction with 500 ml of water), 2) caffeine and water2 (i.e., Experimental Group 2 - ingestion of 200 mg of caffeine in conjunction with 1.0 liter of water), 3)caffeine only (i.e., Experimental Group 3: ingestion of 200 mg of caffeine and no water), and 4) control (i.e. no ingestion of caffeine or water). The research question involves whether systemic hydration may reduce degradation on voice performance caused by caffeine ingestion. It is hypothesized that the hydration conditions will result in a less degraded vocal performance as compared with the nonhydration condition. Additionally, it is hypothesized that ingestion of 1.0 liter of water will have a greater effect on voice performance than ingestion of 500 ml of water. An additional objective of this study is to increase scientific knowledge of voice functioning by providing further data about the effect of the interaction of water and caffeine on voice performance. The results of this project may be a valuable addition to the scientific literature in vocology, and may also contribute to prevention plans for minimizing vocal disturbances. Therefore, vocational programs may include vocal prevention directions based on this study. In addition, knowledge about prevention of voice disorders may be included in the academic curriculum of students enrolled in training programs for professions involving substantial voice use.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Voice Disorders
Keywords
Voice, aerodynamics, acoustics
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Caffeine and hydration.
Arm Type
Experimental
Arm Description
200 mg of caffeine (over the counter caffeine tablet)
1 liter of water
Arm Title
No caffeine, no hydration.
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
C2 (200mg of caffeine; 1/2 L of water)
Other Intervention Name(s)
Caffeine and water 2.
Intervention Description
200mg of caffeine (tablet); 1/2 of water
Intervention Type
Drug
Intervention Name(s)
C3(200mg of caffeine; 1 L of water)
Other Intervention Name(s)
Caffeine and water 3.
Intervention Description
Ingestion of 200 mg of caffeine and 1 Liter of water after between pretest and posttest.
Intervention Type
Drug
Intervention Name(s)
C1 (200mg of caffeine, no water)
Other Intervention Name(s)
Caffeine
Intervention Description
Ingestion of 200mg of caffeine (tablet); no water ingestion.
Intervention Type
Drug
Intervention Name(s)
Placebo (no caffeine, no water).
Other Intervention Name(s)
Control.
Intervention Description
No ingestion of caffeine; no ingestion of water between pretest and posttest.
Primary Outcome Measure Information:
Title
Effect of caffeine and hydration on acoustic measures of voice.
Description
The acoustic measurement of voice include the parameters of relative average perturbation (RAP), shimmer, and sound pressure level (SPL).
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Effect of caffeine and hydration on aerodynamic measures of voice. Effect of caffeine and hydration on aerodynamic measures of voice.
Description
The aerodynamic measurement of voice includes the parameter of airflow. Airflow measurements refer to the amount of air passing through the region of the vocal folds decibels.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy individuals, ranging from 18 to 35 years of age.
Exclusion Criteria:
History of voice disorders, history of coronary disease, history of high blood pressure.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Claudia Franca, Ph.D.
Organizational Affiliation
Southern Illinois University Carbondale
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern Illinois University Carbondale
City
Carbondale
State/Province
Illinois
ZIP/Postal Code
62901
Country
United States
12. IPD Sharing Statement
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Interaction of Caffeine and Hydration on Voice
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