DysphagiaNIH_HVX6NCT05594173

Chewing and Oral Processing of Solid Food

An observational study of Dysphagia, run by University Health Network, Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Dysphagia
What is being tested?: Food texture modification
How many people: 20 participants
Where: 1 siteCanada
Study dates: 13 Sep 2019to 20 Dec 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Study population: Healthy adult volunteers with no history of swallowing difficulty

Who may be able to join

Healthy adults under age 60

Who cannot join

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 .

Trial locations and contacts

1 site in 1 country.

Canada1 site

Toronto Rehabilitation Institute - University Health Network
Toronto, Ontario, M5G 2A2

Other trials in Canada

About this study

Official title: Chewing and Oral Processing of Solid Food in Healthy Swallowing

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.

Read the 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.

Conditions: Dysphagia
Being tested: Food texture modification
Medical subject headings: Deglutition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Food texture modificationOther
Food prepared in three different consistencies: minced and moist, soft and bite-sized and regular, as defined by the International Dysphagia Diet Standardisation Initiative

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline (single timepoint only)
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.
Measured: Baseline (single timepoint only)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Sep 201920 Dec 2020

First posted26 Oct 2022
Study start13 Sep 2019
Primary completion20 Dec 2020
Study completion20 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DysphagiaStudies of the same condition, open and under way.
More trials run by University Health Network, TorontoThe 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: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05594173
Sponsor's protocol ID: 15-9431.10
Other IDs: R01DC011020
Acronym: NIH_HVX6
Status last verified: Oct 2022
First submitted: 21 Oct 2022
Last updated: 21 Nov 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dysphagia trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Chewing and Oral Processing of Solid Food in Healthy Swallowing
ClinicalTrials.gov ID: NCT05594173
Acronym / sponsor ID: NIH_HVX6 / 15-9431.10
Conditions: Dysphagia
Study type: Observational
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: University Health Network, TorontoUniversity, hospital or other
Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
Study start: 13 Sep 2019 (actual)
Primary completion: 20 Dec 2020 (actual)
Study completion: 20 Dec 2020 (actual)
First posted: 26 Oct 2022 (actual)
Results: Posted 21 Nov 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Aim: To explore chewing and oral processing behaviors across solid foods of different consistencies (minced and moist, soft \& bite-sized, regular).

We will measure the number of chews taken per bolus and the overall duration of chewing to understand differences across consistencies.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult
Study population: Healthy adult volunteers with no history of swallowing difficulty

Key inclusion criteria (1 listed)

Healthy adults under age 60

Key exclusion criteria (7 listed)

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

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
Food texture modificationFood prepared in three different consistencies: minced and moist, soft and bite-sized and regular, as defined by the International Dysphagia Diet Standardisation Initiative	Other	–

Primary outcome

Number of Chewing Cycles Per Bolus
Time frame: 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
Time frame: 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.

Results and safety

Results posted to the registry on 21 Nov 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy Participants	20	17

Primary outcome: Number of Chewing Cycles Per Bolus

Time frame: Baseline (single timepoint only). Mean (Standard Deviation). Unit: number of chewing cycles

Measure	Healthy Participants: Carrot n = 14	Healthy Participants: Cracker n = 14	Healthy Participants: Cracker With Barium Paste n = 14	Healthy Participants: Gummy Candy n = 14	Healthy Participants: Minced and Moist Barium Stimulus n = 14	Healthy Participants: Soft and Bite-sized Barium Stimulus n = 14
Value	22 (11)	15 (6)	15 (4)	28 (13)	6 (3)	11 (4)

Population analysed: Data for 3 additional participants could not be analyzed due to poor electromyography signal quality.

Primary outcome: Total Chewing Duration Per Bolus

Time frame: Baseline (single timepoint only). Mean (Standard Deviation). Unit: seconds

Measure	Healthy Participants: Carrot n = 14	Healthy Participants: Cracker n = 14	Healthy Participants: Cracker With Barium Paste n = 14	Healthy Participants: Gummy Candy n = 14	Healthy Participants: Minced and Moist Barium Stimulus n = 14	Healthy Participants: Soft and Bite-sized Barium Stimulus n = 14
Value	14.7 (5.4)	13 (4.3)	12.4 (2.7)	25.1 (10.5)	5.8 (2.6)	9.9 (2.3)

Population analysed: Data for 3 additional participants could not be analyzed due to poor EMG signal quality.

Adverse events

Time frame: 48 hours following data collection. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healthy Participants	0 of 18 (0%)	1 of 18 (5.6%)	0 of 18

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Dysphagia

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
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Active, not recruitingObservational study
Dexmedetomidine Nasal Spray and Postoperative Sore Throat After Bronchoscopy
Postoperative Sore Throat, Bronchoscopy
Not yet recruiting
EEG Feedback-Based Vagus Nerve Stimulation for Post-Stroke Dysphagia
Ischemic Stroke, Post-stroke Dysphagia

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.

Catriona M Steele, PhD principal investigator

University Health Network, Toronto

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 Health Network, Toronto at 1 site in Canada.

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 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 21 Nov 2022. 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 Canada. 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?

Yes. Results are posted in the registry (first posted 21 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Chewing Cycles Per Bolus (time frame: Baseline (single timepoint only)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05594173.

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 21 Nov 2022.