YoungVFD-IPPNCT01120587
Videofluoroscopic of Deglutition Study of the Initiation of Pharyngeal Phase in Young Adults
An observational study of Young and Healthy, run by Fortaleza University.
Trial summary
This study has as objective to characterize the start of pharyngeal phase of swallowing, in the various food consistencies and volumes, with and without the influence of verbal orders, observed on videofluoroscopy of deglutition. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to May 2010
- Phase
- Observational
- 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 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 40 Young adults and healthy, individuals with ages ranging between 20 and 30 years without, mean age 23.5 years, ranging between 20 and 30 years 87.5% (35/40) female 12.5% (5/40) male.
Who may be able to join
- Individuals with ages ranging between 20 and 30 years
- Without complaint of deglutition
- Not submitted to surgeries and/or other treatments in the region of head and neck, with the exception of dental equipment.
Who cannot join
- Individuals submitted to cardiac surgeries, chest and/or abdominal prior
- Patients with diabetes mellitus and/or neurological diseases beyond craniofacial abnormalities.
About this study
Official title: The Start of Pharyngeal Phase of Swallowing in Healthy Individuals
This study has as objective to characterize the start of pharyngeal phase of swallowing, in the various food consistencies and volumes, with and without the influence of verbal orders, observed on videofluoroscopy of deglutition.
Read the detailed description
Quantitative study, transverse and observational study, in the period January to March 2010, in the Center Advanced Diagnosis and Treatment Trajan Almeida, in the city of Fortaleza, Ceará. The sample was composed by 40 individuals, with mean age 23.5 years, 35 (87.5 %) female and five (12.5%) male gender. was carried out an assessment videofluoroscopy swallowing in net consistencies (15 ml of water added to 15 ml of barium net), liquid paste (25ml of barium net), paste (two spoons of 5ml of thickening for 30ml of barium net) and solid (1/2 cracker waffer immersed the barium net), where the individuals remained seated and the images were carried out in the lateral position. From the beginning of the rapid movement of hyoid bone, verified the beginning of pharyngeal phase of swallowing in each consistency.
- Keywords
- Deglutition, Fluoroscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2010 (estimated)
- Study startJan 2010
- Primary completionMar 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for YoungStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fortaleza University
- Sponsor type
- University, hospital or other
- Investigators
- Rita de Cássia A Almeida, Graduate, Principal investigator, Fortaleza UniversityIzabella SN Andrade, Master, Study chair, University FortalezaRenata CB Haguette, Master, Study chair, University Fortaleza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01120587
- Sponsor's protocol ID
- 193/2006
- Acronym
- VFD-IPP
- Status last verified
- Jan 2010
- First submitted
- 10 May 2010
- Last updated
- 11 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Start of Pharyngeal Phase of Swallowing in Healthy Individuals
- ClinicalTrials.gov ID
- NCT01120587
- Acronym / sponsor ID
- VFD-IPP / 193/2006
- Keywords
- Deglutition, Fluoroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fortaleza UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Mar 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 11 May 2010 (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.
This study has as objective to characterize the start of pharyngeal phase of swallowing, in the various food consistencies and volumes, with and without the influence of verbal orders, observed on videofluoroscopy of deglutition.
Detailed description
Quantitative study, transverse and observational study, in the period January to March 2010, in the Center Advanced Diagnosis and Treatment Trajan Almeida, in the city of Fortaleza, Ceará. The sample was composed by 40 individuals, with mean age 23.5 years, 35 (87.5 %) female and five (12.5%) male gender. was carried out an assessment videofluoroscopy swallowing in net consistencies (15 ml of water added to 15 ml of barium net), liquid paste (25ml of barium net), paste (two spoons of 5ml of thickening for 30ml of barium net) and solid (1/2 cracker waffer immersed the barium net), where the individuals remained seated and the images were carried out in the lateral position. From the beginning of the rapid movement of hyoid bone, verified the beginning of pharyngeal phase of swallowing in each consistency.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 40 Young adults and healthy, individuals with ages ranging between 20 and 30 years without, mean age 23.5 years, ranging between 20 and 30 years 87.5% (35/40) female 12.5% (5/40) male.
Key inclusion criteria (3 listed)
- Individuals with ages ranging between 20 and 30 years
- Without complaint of deglutition
- Not submitted to surgeries and/or other treatments in the region of head and neck, with the exception of dental equipment.
Key exclusion criteria (2 listed)
- Individuals submitted to cardiac surgeries, chest and/or abdominal prior
- Patients with diabetes mellitus and/or neurological diseases beyond craniofacial abnormalities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 May 2010.
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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.
Rita de Cássia A Almeida, Graduate principal investigator
Fortaleza University
Izabella SN Andrade, Master study chair
University Fortaleza
Renata CB Haguette, Master study chair
University Fortaleza
Questions about this trial
What is this clinical trial studying?
An observational study of Young and Healthy, run by Fortaleza University.
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 3 inclusion and 2 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 May 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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.
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 May 2010.