DysphagiaNCT03349125
Study: C-Collar and Dysphagia
An observational study of Dysphagia, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this study is to characterize oral-pharyngeal swallow function with the guidance of videofluoroscopy under two conditions, with and without cervical bracing, in patients determined to have dysphagia. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dysphagia
- What is being tested?
- Collar On and Collar Off
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2013to 5 Apr 2018
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inpatients with dysphagia in a cervical brace.
Who may be able to join
- Inpatients receiving treatment for a spine injury
- Treating physician's approval that cervical cervical spinal column injury is stable
- Approval for collar removal by treating physician during VFSS
- Adults 60 and over.
- All races.
- Males and females.
- Glasgow coma scale of 13 or greater.
Who cannot join
- History of oral-pharyngeal dysphagia.
- Neurologic disorders associated with dysphagia including dementia, Parkinson's disease, multiple sclerosis, stroke, and ALS.
- Pharyngeal/laryngeal surgery or head/neck radiation treatment.
- Glasgow coma scale of less than 13 at time of evaluation.
- Patient's with a tracheotomy.
- Barium intolerance.
- Patients who lack the capacity to consent on their own behalf
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin - Madison
Madison, Wisconsin, 53792
About this study
Official title: Effects of Cervical Bracing on Elderly Patients With Dysphagia
The purpose of this study is to characterize oral-pharyngeal swallow function with the guidance of videofluoroscopy under two conditions, with and without cervical bracing, in patients determined to have dysphagia.
Read the detailed description
According to the National Cervical Spinal Cord Injury Statistical Center, 12,000 patients experience acute spinal cord injury (SCI) in the United States annually. It is reported that 16% to 55% of patients with a cervical spinal cord injury (SCI) present with dysphagia which compromises their ability to eat and drink safely as well as their quality of life. Based on previous research, Dysphagia can also result in respiratory complications, particularly pneumonia, which is the most common cause of death in cervical SCI patients. The contribution of swallowing impairment, and associated aspiration risks, to respiratory illnesses and mortality in patients with SCI are unknown. As a first step, the investigators will identify the nature (type of swallowing impairment such as swallow delay, pharyngeal residue, penetration or aspiration) and frequency of occurrence of swallowing impairments in elderly patients with injury to the cervical spinal region. Further, the investigators will determine the effects of standard medical care, specifically, surgical bracing, on swallow function in patients post-cervical SCI.
Patients with SCI present with a range of impairments in the oral and pharyngeal phases of the swallow. These result both from the effects of trauma and medical/surgical management of injury on anatomy and physiology of the swallow mechanism. Earlier studies postulate that Acute SCI can result in reduced base of tongue movement, delayed pharyngeal swallow response, decreased hyolaryngeal excursion with subsequent decrease in cricopharyngeal opening, and pharyngeal wall dysfunction. These swallowing impairments are particularly devastating in older patients who lack the functional reserve to overcome these neuroanatomical insults. Consequently, there is an increased prevalence of dysphagia in the elderly patients with SCI.
Medical and surgical management of SCI can also negatively impact swallow function. Many patients will require neck immobilization following injury. Neck extension, chin or head retraction secondary to cervical bracing may increase the risk or severity of dysphagia by changing the mechanics of swallowing. In addition, fixation at a ninety-degree angle limits the natural flexion or range of movement a patient employs during deglutition. Studies have found that cervical orthoses impacts swallowing physiology in healthy adults. An earlier study reported changes in point of initiation of the swallow, laryngeal penetration, pharyngeal residue and hyoid bone movement. One would expect changes to be more significant in patients with dysphagia, and likely more remarkable in the elderly population who unfortunately, have the highest incidence of cervical SCI. Given the risk factors for dysphagia and pulmonary complications in this population, it is imperative that thorough evaluation of oral-pharyngeal swallow function be completed. However, there is little research addressing the impact of cervical bracing on patients with dysphagia at any age. The study team here aims to determine if cervical bracing contributes to severity of dysphagia.
- Conditions
- Dysphagia
- Being tested
- Collar On, Collar Off
- Keywords
- Cervical Brace, Elderly, Dysphagia, VFSS, Videoflouroscopy, Swallow Problems
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collar OnBehavioural
Collar OffBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Collar On | Individuals who have been referred for videoflouroscopic swallow study (VFSS) as per standard of care, with a stable cervical injury, will have trials of liquids and solids with the Cervical Brace (Collar) on. Receives: Behavioral: Collar On | |
| Collar Off | Individuals who have been referred for videoflouroscopic swallow study (VFSS) as per standard of care, with a stable cervical injury, will have trials of liquids and solids with the Cervical Brace (Collar) off. Receives: Behavioral: Collar Off |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify aspiration between study conditions (with and without a collar).
Measures of dysphagia aspiration (Y/N) and will be obtained in subjects both with and without a collar during the swallow evaluation.
Measured: Comparing aspiration presence between two study conditions (with and without a cervical collar). Data will be reported at the end of study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study start17 Sep 2013
- Primary completion17 May 2017
- Study completion5 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies 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
- Cross-sectional
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jodi Hernandez, MS, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03349125
- Sponsor's protocol ID
- 2017-0222
- Other IDs
- A539772, SMPH/SURGERY/SURGERY*SP
- Status last verified
- Oct 2019
- First submitted
- 25 Oct 2017
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cervical Bracing on Elderly Patients With Dysphagia
- ClinicalTrials.gov ID
- NCT03349125
- Acronym / sponsor ID
- 2017-0222
- Conditions
- Dysphagia
- Keywords
- Cervical Brace, Elderly, Dysphagia, VFSS, Videoflouroscopy, Swallow Problems
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 17 Sep 2013 (actual)
- Primary completion
- 17 May 2017 (actual)
- Study completion
- 5 Apr 2018 (actual)
- First posted
- 21 Nov 2017 (actual)
- 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 this study is to characterize oral-pharyngeal swallow function with the guidance of videofluoroscopy under two conditions, with and without cervical bracing, in patients determined to have dysphagia.
Detailed description
According to the National Cervical Spinal Cord Injury Statistical Center, 12,000 patients experience acute spinal cord injury (SCI) in the United States annually. It is reported that 16% to 55% of patients with a cervical spinal cord injury (SCI) present with dysphagia which compromises their ability to eat and drink safely as well as their quality of life. Based on previous research, Dysphagia can also result in respiratory complications, particularly pneumonia, which is the most common cause of death in cervical SCI patients. The contribution of swallowing impairment, and associated aspiration risks, to respiratory illnesses and mortality in patients with SCI are unknown. As a first step, the investigators will identify the nature (type of swallowing impairment such as swallow delay, pharyngeal residue, penetration or aspiration) and frequency of occurrence of swallowing impairments in elderly patients with injury to the cervical spinal region. Further, the investigators will determine the effects of standard medical care, specifically, surgical bracing, on swallow function in patients post-cervical SCI.
Patients with SCI present with a range of impairments in the oral and pharyngeal phases of the swallow. These result both from the effects of trauma and medical/surgical management of injury on anatomy and physiology of the swallow mechanism. Earlier studies postulate that Acute SCI can result in reduced base of tongue movement, delayed pharyngeal swallow response, decreased hyolaryngeal excursion with subsequent decrease in cricopharyngeal opening, and pharyngeal wall dysfunction. These swallowing impairments are particularly devastating in older patients who lack the functional reserve to overcome these neuroanatomical insults. Consequently, there is an increased prevalence of dysphagia in the elderly patients with SCI.
Medical and surgical management of SCI can also negatively impact swallow function. Many patients will require neck immobilization following injury. Neck extension, chin or head retraction secondary to cervical bracing may increase the risk or severity of dysphagia by changing the mechanics of swallowing. In addition, fixation at a ninety-degree angle limits the natural flexion or range of movement a patient employs during deglutition. Studies have found that cervical orthoses impacts swallowing physiology in healthy adults. An earlier study reported changes in point of initiation of the swallow, laryngeal penetration, pharyngeal residue and hyoid bone movement. One would expect changes to be more significant in patients with dysphagia, and likely more remarkable in the elderly population who unfortunately, have the highest incidence of cervical SCI. Given the risk factors for dysphagia and pulmonary complications in this population, it is imperative that thorough evaluation of oral-pharyngeal swallow function be completed. However, there is little research addressing the impact of cervical bracing on patients with dysphagia at any age. The study team here aims to determine if cervical bracing contributes to severity of dysphagia.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collar On | – | Behavioral: Collar OnIndividuals who have been referred for videoflouroscopic swallow study (VFSS) as per standard of care, with a stable cervical injury, will have trials of liquids and solids with the Cervical Brace (Collar) on. |
| Collar Off | – | Behavioral: Collar OffIndividuals who have been referred for videoflouroscopic swallow study (VFSS) as per standard of care, with a stable cervical injury, will have trials of liquids and solids with the Cervical Brace (Collar) off. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients with dysphagia in a cervical brace.
Key inclusion criteria (7 listed)
- Inpatients receiving treatment for a spine injury
- Treating physician's approval that cervical cervical spinal column injury is stable
- Approval for collar removal by treating physician during VFSS
- Adults 60 and over.
- All races.
Key exclusion criteria (7 listed)
- History of oral-pharyngeal dysphagia.
- Neurologic disorders associated with dysphagia including dementia, Parkinson's disease, multiple sclerosis, stroke, and ALS.
- Pharyngeal/laryngeal surgery or head/neck radiation treatment.
- Glasgow coma scale of less than 13 at time of evaluation.
- Patient's with a tracheotomy.
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 |
|---|---|---|
| Collar On | Behavioural | Collar On |
| Collar Off | Behavioural | Collar Off |
Primary outcome
To identify aspiration between study conditions (with and without a collar).
Time frame: Comparing aspiration presence between two study conditions (with and without a cervical collar). Data will be reported at the end of study completion, an average of 1 year.
Measures of dysphagia aspiration (Y/N) and will be obtained in subjects both with and without a collar during the swallow evaluation.
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 2 Oct 2019.
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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.
Jodi Hernandez, MS principal investigator
University of Wisconsin, Madison
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 Dysphagia, run by University of Wisconsin, Madison 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 7 inclusion and 7 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 2 Oct 2019. 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. 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.
What does the primary outcome measure?
To identify aspiration between study conditions (with and without a collar). (time frame: Comparing aspiration presence between two study conditions (with and without a cervical collar). Data will be reported at the end of study completion, an average of 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 2 Oct 2019.