DysphagiaNCT04975815
Frailty and Dysphagia in Older Adults
An observational study of Dysphagia and Frailty, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this research study is to figure out if there are physical factors such as cognition level, nutrition status, walking speed, and handgrip strength that are associated with the development of swallowing problems. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2022to 14 Mar 2025
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: 69 community-dwelling older adults (23 non-frail, 23 pre-frail, 23 frail) will be recruited from the UW Health Geriatrics clinics, Oakwood Village, a continuing care community for older adults located in Madison, WI, Pleasant View Nursing Home in Monroe, WI, and Skaalen Retirement Services in Stoughton, WI. Participants will attend two research visits. During the first study visit, a comprehensive assessment of limb function, gait, cognitive, and nutrition will be performed. Findings from this first session will allow us to calculate a Fried Frailty Index19 score for each participant and confirm their frailty status (non-frail, pre-frail, frail). During the second research visit, comprehensive swallowing assessments and saliva sample collection will occur. Given this is a cross-sectional study, enrollment will continue until the target of 69 participants (23 per group) is met.
Who may be able to join
- 65 years of age or older
- Ability to provide informed consent or the presence of a legally authorized representative (LAR) who can consent on behalf of the patient
- Post-menopausal (female participants)
- Not pregnant
Who cannot join
- Allergy to barium
- Prior surgery to the head and neck region affecting swallowing-related structures
- Prior chemotherapy or radiation treatment to the head and neck region
- Prior cerebral vascular accident with resulting persistent dysphagia
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Madison Hospital and Clinics
Madison, Wisconsin, 53703
About this study
Official title: Elucidating Factors Contributing to Dysphagia in Frail Older Adults
The purpose of this research study is to figure out if there are physical factors such as cognition level, nutrition status, walking speed, and handgrip strength that are associated with the development of swallowing problems. Investigators want to better understand how swallowing problems develop in older adults with and without frailty. Identifying factors that contribute to swallowing problems, can develop therapies in the future to improve swallowing outcomes for older adults.
This study will be done at the University of Wisconsin-Madison (UW-Madison). A total of about 69 people will participate in this study.
Read the detailed description
This study has 3 specific aims:
Aim 1 will determine the presence and severity of dysphagia in a cohort of older adults based on clinical frailty phenotype; Aim 2 will examine the effects of frailty status on physiological measures of swallowing in older adults; and Aim 3 will characterize relationships among specific functional frailty domains and dysphagia status in older adults.
This proposed research will provide a new understanding of the factors that underlie and contribute to dysphagia across clinical frailty phenotypes. Equipped with this knowledge, future treatment and management approaches can be developed to proactively identify dysphagia risk factors in pre-frail and frail individuals so dysphagia can be prevented or adequately addressed. This work is highly significant due to the large and increasing population of aging people who often suffer from debilitating swallowing impairments and may benefit from optimized treatments that can be developed using knowledge gained from this study.
Per approved protocol amendment on 3/39/2022, saliva samples will be collected to explore the composition and structure of oral microbiota via 16S rRNA gene analysis.
- Keywords
- Clinical frailty phenotype
- Medical subject headings
- Deglutition Disorders, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-frail group | Participants will be assessed using five criteria from the Fried Frailty Index. Index scores"0" will place the participants in Non-frail group. Fried Frailty Index scale determines frailty phenotypes through the assessment of five criteria including walking speed, weight loss, weakness (grip strength), and self-reports of physical activity and exhaustion. | |
| Pre-frail group | Participants will be assessed using five criteria from the Fried Frailty Index. Index scores"1-2" will place the participants in Pre-frail group. Fried Frailty Index scale determines frailty phenotypes through the assessment of five criteria including walking speed, weight loss, weakness (grip strength), and self-reports of physical activity and exhaustion. | |
| Frail group | Participants will be assessed using five criteria from the Fried Frailty Index. Index scores"3-5" will place the participants in Frail group. Fried Frailty Index scale determines frailty phenotypes through the assessment of five criteria including walking speed, weight loss, weakness (grip strength), and self-reports of physical activity and exhaustion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on Modified Barium Swallow Impairment Profile (MBSImP)
Dysphagia presence and severity will be examined using the validated Modified Barium Swallow Impairment Profile (MBSImP). Under MBSImP, swallows are assessed via 17 physiologic components pertaining to the oral and pharyngeal phases of swallowing. These individual components are scored from '0' to '5' with higher scores representing greater (worse) impairment within each component. The MBSImP yields total composite scores for the oral and pharyngeal domains as well as an overall impression score which is the worst score across all 17 components.
Measured: 2 weeks
Secondary outcomes (42)
Number of participants with presence/absence of dysphagia based on Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) scale
Binary dysphagia status will be operationally defined as: DIGEST <1 = non-dysphagic; DIGEST ≥ 1 = dysphagic based on previous investigations.
Measured: 2 weeks
Score on Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) scale: Dysphagia severity
Dysphagia severity will be indexed by DIGEST total scores (0=normal; 1=mild dysphagia; 2=moderate dysphagia; 3=severe dysphagia; 4=life-threatening dysphagia)
Measured: 2 weeks
Swallowing reaction time (ms)
From Videofluoroscopic Swallow Studies (VFSS), the swallowing reaction time (ms) will be calculated.
Measured: 2 weeks
Hyoid burst to upper esophageal sphincter open (ms)
From VFSS, the hyoid burst to upper esophageal sphincter open (ms) will be calculated.
Measured: 2 weeks
Upper esophageal sphincter opening duration (ms)
From VFSS, the upper esophageal sphincter opening duration (ms) will be calculated.
Measured: 2 weeks
Laryngeal closure reaction time (ms)
From VFSS, the laryngeal closure reaction time (ms) will be calculated.
Measured: 2 weeks
Laryngeal closure duration (ms).
From VFSS, the laryngeal closure reaction duration (ms) will be calculated.
Measured: 2 weeks
Extent of hyoid movement (mm)
From Videofluoroscopic Swallow Studies (VFSS), the extent of hyoid movement in mm will be determined
Measured: 2 weeks
Upper esophageal sphincter (UES) opening width (mm)
From Videofluoroscopic Swallow Studies (VFSS), the width of UES opening width in mm will be determined.
Measured: 2 weeks
Pixel-based measure of pharyngeal residue (%C2-C4 squared)
The analysis of swallowing physiology will include a pixel-based measure of pharyngeal residue. Residue will be traced and compared with an anatomic reference scalar (squared length of the C2-4 cervical spine),
Measured: 2 weeks
Pharyngeal constriction ratio (PCR)
The 'Pharyngeal Constriction Ratio' (PCR), a pixel-based measure made on lateral view videofluoroscopy swallow study (VFSS) frames. The PCR is calculated by tracing the unobliterated area of the pharynx (including the bolus) at the point of maximum constriction during the swallow and then dividing that area by a corresponding area measure when the pharynx is at rest.
Measured: 2 weeks
Masticatory efficiency evaluated by Test of Masticating and Swallowing Solids (TOMASS)
The Test of Masticating and Swallowing Solids (TOMASS) was developed as a quantitative assessment of solid bolus ingestion. Participants will be instructed to eat a single portion of a cracker "as quickly as is comfortably possible and when you have finished, say your name out loud". Two independent raters will observe a lateral view of the face and count masticatory cycles by observing jaw movements. Timing of the entire task will be recorded using a stopwatch. Longer mastication times/more masticatory cycles required to eat the cracker are a worse outcomes.
Measured: 2 weeks
Number of participants assessed as pass/fail the three ounce water swallow test
Participants will be recorded as "passing" the three ounce water swallow test if they drank the water uninterrupted without coughing, choking, or without presence of a wet/gurgly voice during or immediately after drinking. If a participant stops drinking before finishing the three ounces, has coughing, choking or a wet/gurgly voice during or immediately after drinking, they will be recorded as "failing" this screen.
Measured: 2 weeks
Pharyngeal Pressure Outcome: Integral pressure (mmHg*time)
Integral pressure will be measured in velopharynx, tongue base, hypopharynx. Maximum pressure = the maximum amount of pressure generated at each of these corresponding sensors during the exam.
Duration = the amount of time pressure is generated at each sensor during the trials.
Integral pressure= a summary measure of maximum pressure x time.
Measured: 2 weeks
Pharyngeal Pressure Outcome: Pharyngeal contractile integral (PhCI)
PhCI is a measure of the "vigor" of the pharyngeal contraction, taking into consideration the pressure amplitude, duration and length of the pharyngeal contraction.
Measured: 2 weeks
Pharyngeal Pressure Outcome: Total swallow duration
Total swallow duration = the total amount of time from pressure onset to pressure offset during a manometry bolus trial.
Measured: 2 weeks
Lingual Pressure Outcome: Mean slope (kpa/seconds)
Slope (kpa/seconds) is the lingual pressure range to maximum lingual pressure over time.
Measured: Day 0
Lingual Pressure Outcome: Maximum lingual pressure
The maximum lingual pressure is also referred to as maximum anterior isometric lingual pressure (MAIP) and it is the highest lingual pressure recorded during the trial.
Measured: Day 0
Lingual Pressure Outcome: Saliva swallow pressure
Saliva swallow pressure is the highest saliva swallowing pressure taken during a saliva pressure trial. Investigators will be taking an average of these 3 values to get the mean.
Measured: Day 0
Lingual Pressure Outcome: Cyclic spatiotemporal index (CSTI)
Cyclic spatiotemporal index represents a measure of pattern variability across repeated trials. Peaks and valleys in each task repetition are amplitude- and time-normalized and aligned with each other. An inbuilt algorithm within the MATLAB program then calculate standard deviations (SDs) across these peak and valley segments at successive 2% intervals, across 50 values per task repetition. The CSTI is then defined as the sum of these SDs with higher CSTI values representing greater pattern variability across the three MAIP trials. Mean CSTI was used in data analysis.
Measured: Day 0
Lingual Pressure Outcome: Cycle duration
Cycle duration is the total time of the lingual pressure trial from pressure onset to pressure offset.
Measured: Day 0
Respiratory Measurement: Maximum expiratory pressure(MEP)
MEP (maximum expiratory pressure): the maximum amount of air the patient breathes out during a trial.
The highest MEP across trials will be recorded for each participant.
Measured: Day 0
Respiratory Measurement: Maximum inspiratory pressure (MIP)
MIP (maximum inspiratory pressure): the maximum amount of air the patient breathes in during a trial. The highest MIP across trials will be recorded for each participant.
Measured: Day 0
Respiratory Measurement: Maximum Forced vital capacity (FVC)
FVC (forced vital capacity): a surrogate measure of lung volume; maximum amount of air a person can breathe out following a maximum inhalation.
The highest FVC across trials will be recorded for each participant.
Measured: Day 0
Respiratory Measurement: Forced Expiratory Volume in 1 second (FEV1)
The FEV1 associated with the highest FVC will be reported.
Measured: Day 0
Respiratory Measurement: FEV1/FVC Ratio
FEV1/FVC ratio associated with the highest FVC will be reported.
Measured: Day 0
Respiratory Measurement: Peak Expiratory Flow (PEF)
The PEF associated with the highest FVC will be reported.
Measured: Day 0
Salivary flow rate (grams/minute)
Salivary flow rate will be determined by the change in collection vial weight over 5 minutes for both unstimulated and stimulated conditions (grams/minute).
Measured: 2 weeks
Extensional viscosity of saliva
Compositional analyses will measure apparent extensional viscosity (ηapp(ɛ))^33 of saliva.
Measured: 2 weeks
Time to break up saliva(ms)
Measured: 2 weeks
Salivary pH
Salivary pH will be measured using a digital pH meter.
Measured: 2 weeks
Mini Nutritional Assessment Score
Nutritional status will be determined for each participant in accordance with scoring guidelines for the Mini Nutritional Assessment. The scale yields a total score out of 30 with higher scores representing more intact/healthy nutritional status. A total score of 24-30 is considered normal nutritional status, scores of 17-23.5 represent risk of malnutrition, and scores <17 indicate malnutrition.
Measured: Day 0
Body Mass Index (BMI)
Participant's weight and height will be combined to calculate BMI in kg/m^2. Participants will be categorized into the following standardized categories: 1) <18.5kg/m^2: underweight; 2) 18.5-24.9kg/m^2: normal/healthy weight; 3) 25-29.9kg/m^2: overweight; 4) ≥30kg/m^2: obese.
Measured: Day 0
Limb function outcome: average handgrip strength
The average handgrip strength across the three trials for each participant will be recorded and utilized in subsequent data analysis.
Measured: Day 0
Gate analysis: cadence (steps per minute)
Measured: Day 0
Gate analysis: normalized walking velocity
Measured: Day 0
Gate analysis: normalized base of support
Measured: Day 0
Gate analysis: step extremity ratio
Measured: Day 0
Gate analysis: percentage of the gait cycle spent in double support time
Measured: Day 0
Presence/absence of exhaustion
Exhaustion will be considered present if a participant answers "a moderate amount of the time" or "most of the time" to this question: "How often in the last week did you feel this way?".
Measured: Day 0
Total physical activity measured as kilocalories expended per week
A weighted estimate of total physical activity (MET-minutes per week) from all reported activities per week will be obtained through the sum of the duration of the activity × frequency per week × MET intensity of each activity domain included in the questionnaire, which will then be converted to kilocalories expended per week.
Measured: Day 0
Montreal Cognitive Assessment (MoCA) score
Cognitive status will be determined by total MoCA scores. A total MoCA score of 26-30 is considered normal (no impairment); scores of 18-25 represent a mild cognitive impairment; scores of 10-17 represent a moderate cognitive impairment; and scores <10 a severe.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start6 Apr 2022
- Primary completion14 Mar 2025
- Study completion14 Mar 2025
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.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Nicole M Rogus-Pulia, PhD, CCC-SLP, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04975815
- Sponsor's protocol ID
- 2021-0536
- Other IDs
- A534255, SMPH/MEDICINE/GER-AD DEV, 1K76AG068590-01, Protocol Amend 11/7/2023, 8K00AG076123-03
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2021
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elucidating Factors Contributing to Dysphagia in Frail Older Adults
- ClinicalTrials.gov ID
- NCT04975815
- Acronym / sponsor ID
- 2021-0536
- Keywords
- Clinical frailty phenotype
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 6 Apr 2022 (actual)
- Primary completion
- 14 Mar 2025 (actual)
- Study completion
- 14 Mar 2025 (actual)
- First posted
- 23 Jul 2021 (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 research study is to figure out if there are physical factors such as cognition level, nutrition status, walking speed, and handgrip strength that are associated with the development of swallowing problems. Investigators want to better understand how swallowing problems develop in older adults with and without frailty. Identifying factors that contribute to swallowing problems, can develop therapies in the future to improve swallowing outcomes for older adults.
This study will be done at the University of Wisconsin-Madison (UW-Madison). A total of about 69 people will participate in this study.
Detailed description
This study has 3 specific aims:
Aim 1 will determine the presence and severity of dysphagia in a cohort of older adults based on clinical frailty phenotype; Aim 2 will examine the effects of frailty status on physiological measures of swallowing in older adults; and Aim 3 will characterize relationships among specific functional frailty domains and dysphagia status in older adults.
This proposed research will provide a new understanding of the factors that underlie and contribute to dysphagia across clinical frailty phenotypes. Equipped with this knowledge, future treatment and management approaches can be developed to proactively identify dysphagia risk factors in pre-frail and frail individuals so dysphagia can be prevented or adequately addressed. This work is highly significant due to the large and increasing population of aging people who often suffer from debilitating swallowing impairments and may benefit from optimized treatments that can be developed using knowledge gained from this study.
Per approved protocol amendment on 3/39/2022, saliva samples will be collected to explore the composition and structure of oral microbiota via 16S rRNA gene analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-frail group | – | –Participants will be assessed using five criteria from the Fried Frailty Index. Index scores"0" will place the participants in Non-frail group. Fried Frailty Index scale determines frailty phenotypes through the assessment of five criteria including walking speed, weight loss, weakness (grip strength), and self-reports of physical activity and exhaustion. |
| Pre-frail group | – | –Participants will be assessed using five criteria from the Fried Frailty Index. Index scores"1-2" will place the participants in Pre-frail group. Fried Frailty Index scale determines frailty phenotypes through the assessment of five criteria including walking speed, weight loss, weakness (grip strength), and self-reports of physical activity and exhaustion. |
| Frail group | – | –Participants will be assessed using five criteria from the Fried Frailty Index. Index scores"3-5" will place the participants in Frail group. Fried Frailty Index scale determines frailty phenotypes through the assessment of five criteria including walking speed, weight loss, weakness (grip strength), and self-reports of physical activity and exhaustion. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- 69 community-dwelling older adults (23 non-frail, 23 pre-frail, 23 frail) will be recruited from the UW Health Geriatrics clinics, Oakwood Village, a continuing care community for older adults located in Madison, WI, Pleasant View Nursing Home in Monroe, WI, and Skaalen Retirement Services in Stoughton, WI. Participants will attend two research visits. During the first study visit, a comprehensive assessment of limb function, gait, cognitive, and nutrition will be performed. Findings from this first session will allow us to calculate a Fried Frailty Index19 score for each participant and confirm their frailty status (non-frail, pre-frail, frail). During the second research visit, comprehensive swallowing assessments and saliva sample collection will occur. Given this is a cross-sectional study, enrollment will continue until the target of 69 participants (23 per group) is met.
Key inclusion criteria (4 listed)
- 65 years of age or older
- Ability to provide informed consent or the presence of a legally authorized representative (LAR) who can consent on behalf of the patient
- Post-menopausal (female participants)
- Not pregnant
Key exclusion criteria (5 listed)
- Allergy to barium
- Prior surgery to the head and neck region affecting swallowing-related structures
- Prior chemotherapy or radiation treatment to the head and neck region
- Prior cerebral vascular accident with resulting persistent dysphagia
- Non-English speaking
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
Score on Modified Barium Swallow Impairment Profile (MBSImP)
Time frame: 2 weeks
Dysphagia presence and severity will be examined using the validated Modified Barium Swallow Impairment Profile (MBSImP). Under MBSImP, swallows are assessed via 17 physiologic components pertaining to the oral and pharyngeal phases of swallowing. These individual components are scored from '0' to '5' with higher scores representing greater (worse) impairment within each component. The MBSImP yields total composite scores for the oral and pharyngeal domains as well as an overall impression score which is the worst score across all 17 components.
42 secondary outcomes
Number of participants with presence/absence of dysphagia based on Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) scale
Time frame: 2 weeks
Score on Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) scale: Dysphagia severity
Time frame: 2 weeks
Swallowing reaction time (ms)
Time frame: 2 weeks
Hyoid burst to upper esophageal sphincter open (ms)
Time frame: 2 weeks
Upper esophageal sphincter opening duration (ms)
Time frame: 2 weeks
Laryngeal closure reaction time (ms)
Time frame: 2 weeks
Laryngeal closure duration (ms).
Time frame: 2 weeks
Extent of hyoid movement (mm)
Time frame: 2 weeks
Upper esophageal sphincter (UES) opening width (mm)
Time frame: 2 weeks
Pixel-based measure of pharyngeal residue (%C2-C4 squared)
Time frame: 2 weeks
Pharyngeal constriction ratio (PCR)
Time frame: 2 weeks
Masticatory efficiency evaluated by Test of Masticating and Swallowing Solids (TOMASS)
Time frame: 2 weeks
Number of participants assessed as pass/fail the three ounce water swallow test
Time frame: 2 weeks
Pharyngeal Pressure Outcome: Integral pressure (mmHg*time)
Time frame: 2 weeks
Pharyngeal Pressure Outcome: Pharyngeal contractile integral (PhCI)
Time frame: 2 weeks
Pharyngeal Pressure Outcome: Total swallow duration
Time frame: 2 weeks
Lingual Pressure Outcome: Mean slope (kpa/seconds)
Time frame: Day 0
Lingual Pressure Outcome: Maximum lingual pressure
Time frame: Day 0
Lingual Pressure Outcome: Saliva swallow pressure
Time frame: Day 0
Lingual Pressure Outcome: Cyclic spatiotemporal index (CSTI)
Time frame: Day 0
Lingual Pressure Outcome: Cycle duration
Time frame: Day 0
Respiratory Measurement: Maximum expiratory pressure(MEP)
Time frame: Day 0
Respiratory Measurement: Maximum inspiratory pressure (MIP)
Time frame: Day 0
Respiratory Measurement: Maximum Forced vital capacity (FVC)
Time frame: Day 0
Respiratory Measurement: Forced Expiratory Volume in 1 second (FEV1)
Time frame: Day 0
Respiratory Measurement: FEV1/FVC Ratio
Time frame: Day 0
Respiratory Measurement: Peak Expiratory Flow (PEF)
Time frame: Day 0
Salivary flow rate (grams/minute)
Time frame: 2 weeks
Extensional viscosity of saliva
Time frame: 2 weeks
Time to break up saliva(ms)
Time frame: 2 weeks
Salivary pH
Time frame: 2 weeks
Mini Nutritional Assessment Score
Time frame: Day 0
Body Mass Index (BMI)
Time frame: Day 0
Limb function outcome: average handgrip strength
Time frame: Day 0
Gate analysis: cadence (steps per minute)
Time frame: Day 0
Gate analysis: normalized walking velocity
Time frame: Day 0
Gate analysis: normalized base of support
Time frame: Day 0
Gate analysis: step extremity ratio
Time frame: Day 0
Gate analysis: percentage of the gait cycle spent in double support time
Time frame: Day 0
Presence/absence of exhaustion
Time frame: Day 0
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 9 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Dysphagia
RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Recruiting
taVNS in Infants Severe Dysphagia
Dysphagia, Swallowing Disorders
Not yet recruitingPhase 2
Early Feeding TL Trial
Total Laryngectomy
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
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.
Nicole M Rogus-Pulia, PhD, CCC-SLP 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 and Frailty, 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 4 inclusion and 5 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 9 Jul 2026. 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?
Score on Modified Barium Swallow Impairment Profile (MBSImP) (time frame: 2 weeks). 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 9 Jul 2026.