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Completed

NCT Number: NCT05132452

The Test of Mastication and Swallowing Solids and the Timed Water Swallow Test

This study aimed to gather more information regarding two clinically relevant tests: The Test of Mastication and Swallowing Solids (TOMASS) and the Timed Water Swallow Test (TWST). Both tests can be used clinically as part of swallowing disorders evaluation.

The aims of the study were to assess the reliability of the two tests, to document the effects of age and gender on the outcome measures of the TOMASS and TWST and to explore the relationship between participants' function in the two tests. To do that, 298 healthy participants were included. All of them did not have dysphagia. Most of them were elderly.

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Key information

Conditions

Healthy Aging Behavior Coitus Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Gender Otorhinolaryngologic Diseases Pharyngeal Diseases Sexual Behavior Swallowing Disorder

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Background: Quantitative measures of swallowing function can increase accuracy, reliability, and improve clinical decision making. The Test of Mastication and Swallowing Solids (TOMASS) and the Timed Water Swallow Test (TWST) are functional tests of swallowing that provide quantitative results.

Objectives: To explore the relationship between TOMASS and TWST; evaluate test-retest and interrater reliability; explore age and gender effects; and to gather normative data.

Methods: Healthy community dwelling participants (n = 298, ≥20 years old) were recruited. Of those, 126 were included in the reliability study. Participants completed the TWST and TOMASS.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all participants were eligible to participate if they were over 20 years of age, with no known medical history of dysphagia, had an SDQ score of less than 11, indicating no suspicion for dysphagia, were able to give a written informed consent, and could follow simple verbal instructions. In addition, all participants indicated that they do not avoid eating crackers due to swallowing disorders or allergies.

Exclusion criteria

  • SDQ over 11 or medically reported dysphagia not eating crackers due to swallowing difficulty allergy to gluten

Treatment and study plan

The Test of Mastication and Swallowing Solids (TOMASS) and the Timed Water Swallow Test (TWST)

Diagnostic Test

Participants swallowed one cracker for the TOMASS. They swallowed 150 mL of water for the TWST.

Primary outcomes

  1. duration

    Time frame: one-off assessment

    length of time required to complete the task

  2. swallows

    Time frame: one-off assessment

    number of swallows required to complete the task

  3. bites

    Time frame: one-off assessment

    number of bites required to eat the cracker

  4. masticatory cycles

    Time frame: one-off assessment

    number of masticatory cycles required to eat the cracker

  5. volume

    Time frame: one-off assessment

    the amount of water swallowed

Sponsors and collaborators

Lead sponsor

University of Haifa

Other

Registry information

Official study title

The Test of Mastication and Swallowing Solids and the Timed Water Swallow Test: Reliability, Associations, Age and Gender Effects, and Normative Data

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 24, 2021
Registry last updated
Nov 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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