Dysphagia
Conditions
Brief summary
Food texture modification is commonly used as an intervention for people with dysphagia (swallowing impairment). However, the field currently lacks a proper understanding of how this intervention works. The overall goal of this project was to collect measurements of food bolus transit through the oropharynx (i.e., mouth and throat) during chewing, oral processing and swallowing.
Detailed description
Aim: To explore chewing and oral processing behaviors across solid foods of different consistencies (minced and moist, soft & bite-sized, regular). Healthy adult participants will be asked to swallow foods representative of the minced and moist, soft and bite-sized and regular consistency levels of the International Dysphagia Diet Standardisation Initiative. We will measure the number of chews taken per bolus and the overall duration of chewing to understand differences across consistencies.
Interventions
OTHERFood texture modification
Food prepared in three different consistencies: minced and moist, soft and bite-sized and regular, as defined by the International Dysphagia Diet Standardisation Initiative
Sponsors
National Institute on Deafness and Other Communication Disorders (NIDCD)
University Health Network, Toronto
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adults under age 60
Exclusion criteria
* prior history of swallowing, motor speech, gastro-esophageal or neurological difficulties, chronic sinusitis or taste disturbance. * history of surgery to the speech or swallowing apparatus (other than routine tonsillectomy or adenoidectomy) * Type 1 Diabetes * Current use of dentures * cognitive communication difficulties that may hinder comprehension of the study documents or instructions * known allergies to medical adhesive * known allergies to ingredients of the food products used in the experiment .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Chewing Cycles Per Bolus | Baseline (single timepoint only) | Using surface electromyography (sEMG) of the masseter muscle, we will count the number of muscle contraction spikes (i.e. chewing cycles) seen for chewing activity for a single comfortable bite of each bolus type. |
| Total Chewing Duration Per Bolus | Baseline (single timepoint only) | Using surface electromyography (sEMG) of the masseter muscle, we will count the total duration of chewing activity for a single comfortable bite of each bolus type. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Healthy Participants Healthy adults with no history of difficulties with chewing or swallowing. | 17 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | COVID-19 Pandemic | 2 |
Baseline characteristics
| Characteristic | Healthy Participants |
|---|---|
| Age, Continuous | 26 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment Canada | 17 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 18 |
| other Total, other adverse events | 1 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
Primary
Number of Chewing Cycles Per Bolus
Using surface electromyography (sEMG) of the masseter muscle, we will count the number of muscle contraction spikes (i.e. chewing cycles) seen for chewing activity for a single comfortable bite of each bolus type.
Time frame: Baseline (single timepoint only)
Population: Data for 3 additional participants could not be analyzed due to poor electromyography signal quality.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Participants: Carrot | Number of Chewing Cycles Per Bolus | 22 number of chewing cycles | Standard Deviation 11 |
| Healthy Participants: Cracker | Number of Chewing Cycles Per Bolus | 15 number of chewing cycles | Standard Deviation 6 |
| Healthy Participants: Cracker With Barium Paste | Number of Chewing Cycles Per Bolus | 15 number of chewing cycles | Standard Deviation 4 |
| Healthy Participants: Gummy Candy | Number of Chewing Cycles Per Bolus | 28 number of chewing cycles | Standard Deviation 13 |
| Healthy Participants: Minced and Moist Barium Stimulus | Number of Chewing Cycles Per Bolus | 6 number of chewing cycles | Standard Deviation 3 |
| Healthy Participants: Soft and Bite-sized Barium Stimulus | Number of Chewing Cycles Per Bolus | 11 number of chewing cycles | Standard Deviation 4 |
Primary
Total Chewing Duration Per Bolus
Using surface electromyography (sEMG) of the masseter muscle, we will count the total duration of chewing activity for a single comfortable bite of each bolus type.
Time frame: Baseline (single timepoint only)
Population: Data for 3 additional participants could not be analyzed due to poor EMG signal quality.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Participants: Carrot | Total Chewing Duration Per Bolus | 14.7 seconds | Standard Deviation 5.4 |
| Healthy Participants: Cracker | Total Chewing Duration Per Bolus | 13 seconds | Standard Deviation 4.3 |
| Healthy Participants: Cracker With Barium Paste | Total Chewing Duration Per Bolus | 12.4 seconds | Standard Deviation 2.7 |
| Healthy Participants: Gummy Candy | Total Chewing Duration Per Bolus | 25.1 seconds | Standard Deviation 10.5 |
| Healthy Participants: Minced and Moist Barium Stimulus | Total Chewing Duration Per Bolus | 5.8 seconds | Standard Deviation 2.6 |
| Healthy Participants: Soft and Bite-sized Barium Stimulus | Total Chewing Duration Per Bolus | 9.9 seconds | Standard Deviation 2.3 |