- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01435837
Interaction of Caffeine and Hydration on Voice
June 10, 2013 updated by: Southern Illinois University Carbondale
Effects of the Interaction of Caffeine and Hydration on Voice Performance
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Carbondale, Illinois, United States, 62901
- Southern Illinois University Carbondale
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Caffeine and hydration.
200 mg of caffeine (over the counter caffeine tablet) 1 liter of water |
200mg of caffeine (tablet); 1/2 of water
Other Names:
Ingestion of 200 mg of caffeine and 1 Liter of water after between pretest and posttest.
Other Names:
Ingestion of 200mg of caffeine (tablet); no water ingestion.
Other Names:
No ingestion of caffeine; no ingestion of water between pretest and posttest.
Other Names:
|
PLACEBO_COMPARATOR: No caffeine, no hydration.
|
200mg of caffeine (tablet); 1/2 of water
Other Names:
Ingestion of 200 mg of caffeine and 1 Liter of water after between pretest and posttest.
Other Names:
Ingestion of 200mg of caffeine (tablet); no water ingestion.
Other Names:
No ingestion of caffeine; no ingestion of water between pretest and posttest.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of caffeine and hydration on acoustic measures of voice.
Time Frame: 1 year
|
The acoustic measurement of voice include the parameters of relative average perturbation (RAP), shimmer, and sound pressure level (SPL).
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of caffeine and hydration on aerodynamic measures of voice. Effect of caffeine and hydration on aerodynamic measures of voice.
Time Frame: 1 year
|
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.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (ACTUAL)
May 1, 2013
Study Completion (ACTUAL)
May 1, 2013
Study Registration Dates
First Submitted
September 24, 2010
First Submitted That Met QC Criteria
September 16, 2011
First Posted (ESTIMATE)
September 19, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
June 11, 2013
Last Update Submitted That Met QC Criteria
June 10, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Respiratory Tract Diseases
- Neurologic Manifestations
- Otorhinolaryngologic Diseases
- Laryngeal Diseases
- Voice Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Purinergic Antagonists
- Purinergic Agents
- Phosphodiesterase Inhibitors
- Purinergic P1 Receptor Antagonists
- Central Nervous System Stimulants
- Caffeine
Other Study ID Numbers
- 09433
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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