StrokeNCT00780364
Sour Taste and Cold Temperature in Dysphagia
An observational study of Stroke, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
Trial summary
The objective is to establish the effect of sour taste and cold temperature on the pharyngeal swallowing transit time after ischemic hemisphere stroke. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Stroke
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2008to Feb 2011
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients in hospital
Who may be able to join
- Clinical diagnosis of stroke
Who cannot join
- instability clinic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sour Taste and Cold Temperature Effects on Pharyngeal Transit Time After Ischemic Stroke:Anatomic and Functional Bases.
The objective is to establish the effect of sour taste and cold temperature on the pharyngeal swallowing transit time after ischemic hemisphere stroke.
Read the detailed description
Over the past decade there were many studies over normal and pathological swallowing that discuss the influence of taste and temperature. Nevertheless there were many questions on the issue that remains to be solved, including the hemispheric lateralization of lesions dysphagic patients remains also to be fully understood.Swallowing disorder is defined as oropharyngeal dysphagia in presence of alterations in any phase of the complex swallowing dynamics. It could be congenital or acquired, affecting nutritional aspects, hydration, lung function and the individual's social integration [1]. Stroke, has a high incidence among neurological diseases, and cause disturbs on swallowing dynamics presenting signs of dysphagia in at least 50% of cases.A study that analyzed swallowing dynamics by videofluoroscopy in individuals with history of one or more stroke episodes with oropharyngeal dysphagia shows shorter pharyngeal and oropharyngeal transit times with cold stimulus than without them. Other study of heterogeneous neurological diseases such as cerebral palsy, brain trauma, stroke, and Alzheimer's disease, concluded that sour taste improved swallowing, minimizing laryngotracheal penetration and aspiration in individuals with neurological damaged. Chen et al. in an analysis of 42 healthy individuals with several taste bolus found that awareness and arousal could also influence the swallowing function.
- Conditions
- Stroke
- Keywords
- stroke; sour taste; cold temperature; pharyngeal swallowing
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Sour Taste and Cold Temperature in Dysphagia
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- UPECLIN HC FM Botucatu Unesp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paula Cristina Cola, UPECLIN HC FM Botucatu Unesp
- Investigators
- Paula C Cola, master, Principal investigator, São Paulo State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00780364
- Sponsor's protocol ID
- upeclin/HC/FMB-Unesp-18
- Status last verified
- Jun 2012
- First submitted
- 24 Oct 2008
- Last updated
- 1 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sour Taste and Cold Temperature Effects on Pharyngeal Transit Time After Ischemic Stroke:Anatomic and Functional Bases.
- ClinicalTrials.gov ID
- NCT00780364
- Acronym / sponsor ID
- upeclin/HC/FMB-Unesp-18
- Conditions
- Stroke
- Keywords
- stroke; sour taste; cold temperature; pharyngeal swallowing
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 30 participants (actual)
- Lead sponsor
- UPECLIN HC FM Botucatu UnespUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 27 Oct 2008 (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 objective is to establish the effect of sour taste and cold temperature on the pharyngeal swallowing transit time after ischemic hemisphere stroke.
Detailed description
Over the past decade there were many studies over normal and pathological swallowing that discuss the influence of taste and temperature. Nevertheless there were many questions on the issue that remains to be solved, including the hemispheric lateralization of lesions dysphagic patients remains also to be fully understood.Swallowing disorder is defined as oropharyngeal dysphagia in presence of alterations in any phase of the complex swallowing dynamics. It could be congenital or acquired, affecting nutritional aspects, hydration, lung function and the individual's social integration [1]. Stroke, has a high incidence among neurological diseases, and cause disturbs on swallowing dynamics presenting signs of dysphagia in at least 50% of cases.A study that analyzed swallowing dynamics by videofluoroscopy in individuals with history of one or more stroke episodes with oropharyngeal dysphagia shows shorter pharyngeal and oropharyngeal transit times with cold stimulus than without them. Other study of heterogeneous neurological diseases such as cerebral palsy, brain trauma, stroke, and Alzheimer's disease, concluded that sour taste improved swallowing, minimizing laryngotracheal penetration and aspiration in individuals with neurological damaged. Chen et al. in an analysis of 42 healthy individuals with several taste bolus found that awareness and arousal could also influence the swallowing function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients in hospital
Key inclusion criteria (1 listed)
- Clinical diagnosis of stroke
Key exclusion criteria (1 listed)
- instability clinic
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
Sour Taste and Cold Temperature in Dysphagia
Time frame: 24 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2015.
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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.
Paula C Cola, master principal investigator
São Paulo State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
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: stopped early, as of the sponsor's last update on 1 Jun 2015. 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 Brazil. 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. 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 was stopped early. Results are not available in the source record.
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?
Sour Taste and Cold Temperature in Dysphagia (time frame: 24 months). 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 1 Jun 2015.