NCT01435837

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Oct 2010

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2010

Completed
7 days until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
12 months until next milestone

First Posted

Study publicly available on registry

September 19, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

June 11, 2013

Status Verified

June 1, 2013

Enrollment Period

2.6 years

First QC Date

September 24, 2010

Last Update Submit

June 10, 2013

Conditions

Voice Disorders

Keywords

Voiceaerodynamicsacoustics

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Effect of caffeine and hydration on aerodynamic measures of voice. Effect of caffeine and hydration on aerodynamic measures of voice.

    1 year

Study Arms (2)

Caffeine and hydration.

EXPERIMENTAL

200 mg of caffeine (over the counter caffeine tablet) 1 liter of water

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).

No caffeine, no hydration.

PLACEBO COMPARATOR
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).

Interventions

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

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

Also known as: Caffeine and water 2.
Caffeine and hydration.No caffeine, no hydration.
C3(200mg of caffeine; 1 L of water)DRUG

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

Also known as: Caffeine and water 3.
Caffeine and hydration.No caffeine, no hydration.
C1 (200mg of caffeine, no water)DRUG

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

Also known as: Caffeine
Caffeine and hydration.No caffeine, no hydration.
Placebo (no caffeine, no water).DRUG

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

Also known as: Control.
Caffeine and hydration.No caffeine, no hydration.

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy individuals, ranging from 18 to 35 years of age.

You may not qualify if:

  • History of voice disorders, history of coronary disease, history of high blood pressure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southern Illinois University Carbondale

Carbondale, Illinois, 62901, United States

Location

MeSH Terms

Conditions

Voice Disorders

Interventions

CaffeineWater

Condition Hierarchy (Ancestors)

Laryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Maria Claudia Franca, Ph.D.

    Southern Illinois University Carbondale

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2010

First Posted

September 19, 2011

Study Start

October 1, 2010

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

June 11, 2013

Record last verified: 2013-06

Locations

US(1)