Interaction of Caffeine and Hydration on Voice

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Southern Illinois University Carbondale
ClinicalTrials.gov Identifier:
NCT01435837
First received: September 24, 2010
Last updated: June 10, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Voice Disorders
Drug: C2 (200mg of caffeine; 1/2 L of water)
Drug: C3(200mg of caffeine; 1 L of water)
Drug: C1 (200mg of caffeine, no water)
Drug: Placebo (no caffeine, no water).
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Effects of the Interaction of Caffeine and Hydration on Voice Performance

Resource links provided by NLM:


Further study details as provided by Southern Illinois University Carbondale:

Primary Outcome Measures:
  • Effect of caffeine and hydration on acoustic measures of voice. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Enrollment: 80
Study Start Date: October 2010
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Caffeine and hydration.

200 mg of caffeine (over the counter caffeine tablet)

1 liter of water

Drug: C2 (200mg of caffeine; 1/2 L of water)
200mg of caffeine (tablet); 1/2 of water
Other Name: Caffeine and water 2.
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.
Other Name: Caffeine and water 3.
Drug: C1 (200mg of caffeine, no water)
Ingestion of 200mg of caffeine (tablet); no water ingestion.
Other Name: Caffeine
Drug: Placebo (no caffeine, no water).
No ingestion of caffeine; no ingestion of water between pretest and posttest.
Other Name: Control.
Placebo Comparator: No caffeine, no hydration. Drug: C2 (200mg of caffeine; 1/2 L of water)
200mg of caffeine (tablet); 1/2 of water
Other Name: Caffeine and water 2.
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.
Other Name: Caffeine and water 3.
Drug: C1 (200mg of caffeine, no water)
Ingestion of 200mg of caffeine (tablet); no water ingestion.
Other Name: Caffeine
Drug: Placebo (no caffeine, no water).
No ingestion of caffeine; no ingestion of water between pretest and posttest.
Other Name: Control.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01435837

Locations
United States, Illinois
Southern Illinois University Carbondale
Carbondale, Illinois, United States, 62901
Sponsors and Collaborators
Southern Illinois University Carbondale
Investigators
Principal Investigator: Maria Claudia Franca, Ph.D. Southern Illinois University Carbondale
  More Information

No publications provided

Responsible Party: Southern Illinois University Carbondale
ClinicalTrials.gov Identifier: NCT01435837     History of Changes
Other Study ID Numbers: 09433
Study First Received: September 24, 2010
Last Updated: June 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Southern Illinois University Carbondale:
Voice
aerodynamics
acoustics

Additional relevant MeSH terms:
Voice Disorders
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on April 14, 2014