Interaction of Caffeine and Hydration on Voice

NCT ID: NCT01435837

Last Updated: 2013-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2013-05-31

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.

Conditions

Voice Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Caffeine and hydration.

200 mg of caffeine (over the counter caffeine tablet)

1 liter of water

Group Type: EXPERIMENTAL

C2 (200mg of caffeine; 1/2 L of water)

Intervention Type: DRUG

200mg of caffeine (tablet); 1/2 of water

C3(200mg of caffeine; 1 L of water)

Intervention Type: DRUG

Ingestion of 200 mg of caffeine and 1 Liter of water after between pretest and posttest.

C1 (200mg of caffeine, no water)

Intervention Type: DRUG

Ingestion of 200mg of caffeine (tablet); no water ingestion.

Placebo (no caffeine, no water).

Intervention Type: DRUG

No ingestion of caffeine; no ingestion of water between pretest and posttest.

No caffeine, no hydration.

Group Type: PLACEBO_COMPARATOR

C2 (200mg of caffeine; 1/2 L of water)

Intervention Type: DRUG

200mg of caffeine (tablet); 1/2 of water

C3(200mg of caffeine; 1 L of water)

Intervention Type: DRUG

Ingestion of 200 mg of caffeine and 1 Liter of water after between pretest and posttest.

C1 (200mg of caffeine, no water)

Intervention Type: DRUG

Ingestion of 200mg of caffeine (tablet); no water ingestion.

Placebo (no caffeine, no water).

Intervention Type: DRUG

No ingestion of caffeine; no ingestion of water between pretest and posttest.

Interventions

C2 (200mg of caffeine; 1/2 L of water)

200mg of caffeine (tablet); 1/2 of water

Intervention Type: DRUG

C3(200mg of caffeine; 1 L of water)

Ingestion of 200 mg of caffeine and 1 Liter of water after between pretest and posttest.

Intervention Type: DRUG

C1 (200mg of caffeine, no water)

Ingestion of 200mg of caffeine (tablet); no water ingestion.

Intervention Type: DRUG

Placebo (no caffeine, no water).

No ingestion of caffeine; no ingestion of water between pretest and posttest.

Intervention Type: DRUG

Other Intervention Names

Caffeine and water 2.; Caffeine and water 3.; Caffeine; Control.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Southern Illinois University Carbondale

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Claudia Franca, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Southern Illinois University Carbondale

Locations

Southern Illinois University Carbondale

Carbondale, Illinois, United States

Countries

United States

Other Identifiers

09433

Identifier Type: -

Identifier Source: org_study_id