Voice DisordersEarly Phase 1NCT01435837
Interaction of Caffeine and Hydration on Voice
A Early Phase 1 study testing C2 (200mg of caffeine; 1/2 L of water), C3(200mg of caffeine; 1 L of water) and C1 (200mg of caffeine, no water) in people with Voice Disorders, run by Southern Illinois University Carbondale at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Voice Disorders
- What is being tested?
- C2 (200mg of caffeine; 1/2 L of water), C3(200mg of caffeine; 1 L of water) and C1 (200mg of caffeine, no water)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to May 2013
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals, ranging from 18 to 35 years of age.
Who cannot join
- History of voice disorders, history of coronary disease, history of high blood pressure.
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern Illinois University Carbondale
Carbondale, Illinois, 62901
About this study
Official title: Effects of the Interaction of Caffeine and Hydration on Voice Performance
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.
Read the 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
- Being tested
- C2 (200mg of caffeine; 1/2 L of water), C3(200mg of caffeine; 1 L of water), C1 (200mg of caffeine, no water), Placebo (no caffeine, no water).
- Keywords
- Voice, aerodynamics, acoustics
- Medical subject headings
- Voice Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C2 (200mg of caffeine; 1/2 L of water)Drug
Also called Caffeine and water 2.
200mg of caffeine (tablet); 1/2 of water
C3(200mg of caffeine; 1 L of water)Drug
Also called Caffeine and water 3.
Ingestion of 200 mg of caffeine and 1 Liter of water after between pretest and posttest.
C1 (200mg of caffeine, no water)Drug
Also called Caffeine
Ingestion of 200mg of caffeine (tablet); no water ingestion.
Placebo (no caffeine, no water).Drug
Also called Control.
No ingestion of caffeine; no ingestion of water between pretest and posttest.
| Study group | Role | What they receive |
|---|---|---|
| Caffeine and hydration. | Experimental | 200 mg of caffeine (over the counter caffeine tablet)
1 liter of water Receives: 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 | Not described Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2011 (estimated)
- Study startOct 2010
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Voice DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern Illinois University Carbondale
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Claudia Franca, Ph.D., Principal investigator, Southern Illinois University Carbondale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01435837
- Sponsor's protocol ID
- 09433
- Status last verified
- Jun 2013
- First submitted
- 24 Sep 2010
- Last updated
- 11 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Interaction of Caffeine and Hydration on Voice Performance
- ClinicalTrials.gov ID
- NCT01435837
- Acronym / sponsor ID
- 09433
- Conditions
- Voice Disorders
- Keywords
- Voice, aerodynamics, acoustics
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Southern Illinois University CarbondaleUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 19 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caffeine and hydration. | Experimental | 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).200 mg of caffeine (over the counter caffeine tablet) 1 liter of 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). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy individuals, ranging from 18 to 35 years of age.
Key exclusion criteria (1 listed)
- History of voice disorders, history of coronary disease, history of high blood pressure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C2 (200mg of caffeine; 1/2 L of water)Also: Caffeine and water 2.200mg of caffeine (tablet); 1/2 of water | Drug | Caffeine and hydration., No caffeine, no hydration. |
| C3(200mg of caffeine; 1 L of water)Also: Caffeine and water 3.Ingestion of 200 mg of caffeine and 1 Liter of water after between pretest and posttest. | Drug | Caffeine and hydration., No caffeine, no hydration. |
| C1 (200mg of caffeine, no water)Also: CaffeineIngestion of 200mg of caffeine (tablet); no water ingestion. | Drug | Caffeine and hydration., No caffeine, no hydration. |
| Placebo (no caffeine, no water).Also: Control.No ingestion of caffeine; no ingestion of water between pretest and posttest. | Drug | Caffeine and hydration., No caffeine, no hydration. |
Primary outcome
Effect of caffeine and hydration on acoustic measures of voice.
Time frame: 1 year
The acoustic measurement of voice include the parameters of relative average perturbation (RAP), shimmer, and sound pressure level (SPL).
1 secondary outcome
Effect of caffeine and hydration on aerodynamic measures of voice. Effect of caffeine and hydration on aerodynamic measures of voice.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2013.
Related trials for Voice Disorders
Not yet recruiting
Starry-Sky Projection and Maternal Voice for Sleep After Pediatric Cardiac Surgery
Congenital Heart Disease (CHD), Postoperative Sleep
Not yet recruiting
Endotracheal Tube Versus Transcartilage Needle Electrodes for Nerve Monitoring in Thyroid Surgery
Thyroid Diseases, Recurrent Laryngeal Nerve Injury
Not yet recruiting
GOT VOICE Feasibility With In-Person Group Singing
Elderly, Coronary Arterial Disease (CAD)
RecruitingObservational study
Collection of Clinical Data and Specimens for Research in Hearing, Balance, Taste, Smell, Voice, Speech, and Language Disorders.
Hearing Loss, Deafness
RecruitingObservational study
Voice-based Outcome Identification and Clinical Evaluation in Heart Failure
Heart Failure, Chronic Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Claudia Franca, Ph.D. principal investigator
Southern Illinois University Carbondale
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing C2 (200mg of caffeine; 1/2 L of water), C3(200mg of caffeine; 1 L of water) and C1 (200mg of caffeine, no water) in people with Voice Disorders, run by Southern Illinois University Carbondale at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of caffeine and hydration on acoustic measures of voice. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2013.