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NCT01435837 · ClinicalTrials.gov registry record · Early Phase 1

Interaction of Caffeine and Hydration on Voice

A Early Phase 1 study of Voice Disorders, sponsored by Southern Illinois University Carbondale.

Completed
Registry status
Early Phase 1
Development phase
80
Enrollment target
1
Study location

NCT01435837: Completed Early Phase 1 study of Voice Disorders, sponsored by Southern Illinois University Carbondale.

NCT01435837 is a Early Phase 1 study of Voice Disorders that has completed, run by Southern Illinois University Carbondale. The registered enrollment target is 80 participants, roughly in line with the 85-participant average among 7 other Voice Disorders trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01435837, a Early Phase 1 study of Voice Disorders, has completed, sponsored by Southern Illinois University Carbondale.

COMPLETED
Registry status
Early Phase 1
Development phase
80 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

The acoustic measurement of voice include the parameters of relative average perturbation (RAP), shimmer, and sound pressure level (SPL).

Conditions Studied

Interventions

  • 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).

Study Locations (1)

Illinois

  • Southern Illinois University Carbondale - Carbondale

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2010-10
Est. Completion 2013-05
Phase Early Phase 1

What the finished NCT01435837 record still lists

NCT01435837 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, roughly in line with the 85-participant average among 7 other Voice Disorders trials with a reported enrollment target.

The record links to 1 condition, with Voice Disorders appearing as the primary indexed condition, and to 4 interventions - of which C2 (200mg of caffeine; 1/2 L of water) is the first listed.

NCT01435837 reports a single indexed study location in Illinois.

Frequently Asked Questions

What is clinical trial NCT01435837 about?

NCT01435837 is a clinical study titled "Interaction of Caffeine and Hydration on Voice". 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 b...

What is the current status of trial NCT01435837?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 80 participants. The study started on 2010-10. Estimated completion is 2013-05.

What conditions does trial NCT01435837 study?

This clinical trial studies the following conditions: Voice Disorders.

What interventions are being tested in trial NCT01435837?

The interventions under investigation include: 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). (DRUG).

Who is sponsoring clinical trial NCT01435837?

This trial is sponsored by Southern Illinois University Carbondale, which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01435837 being conducted?

This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT01435837, the US trial registry maintained by the National Library of Medicine. NCT01435837 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.