Interaction of Caffeine and Hydration on Voice

Voice Disorders Clinical Trial

Official title:

Effects of the Interaction of Caffeine and Hydration on Voice Performance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01435837
• Other study ID #: 09433
• Status: Completed
• Phase: Phase 0
• First received: September 24, 2010
• Last updated: June 10, 2013
• Start date: October 2010
• Est. completion date: May 2013

Study information

• Verified date: June 2013
• Source: Southern Illinois University Carbondale
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Voice Disorders

Intervention

Drug:
• C2 (200mg of caffeine; 1/2 L of water)
200mg of caffeine (tablet); 1/2 of water
• C3(200mg of caffeine; 1 L of water)
Ingestion of 200 mg of caffeine and 1 Liter of water after between pretest and posttest.
• C1 (200mg of caffeine, no water)
Ingestion of 200mg of caffeine (tablet); no water ingestion.
• Placebo (no caffeine, no water).
No ingestion of caffeine; no ingestion of water between pretest and posttest.

Locations

Country	Name	City	State
United States	Southern Illinois University Carbondale	Carbondale	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Southern Illinois University Carbondale

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	1 year	No
Secondary	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.	1 year	No