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

NCT ID: NCT05132452

Last Updated: 2021-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

298 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-01

Study Completion Date

2018-12-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Aging Gender Swallowing Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

adults living in the community

Healthy community dwelling participants, aged 20 year old and above, without dysphagia.

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

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Haifa

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Oshrat Sella

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

oshrat sella, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Haifa

References

Explore related publications, articles, or registry entries linked to this study.

Sarve AR, Krishnamurthy R, Balasubramanium RK. The timed water test of swallowing: Reliability, validity, and normative data from Indian population. Int J Health Sci (Qassim). 2021 Mar-Apr;15(2):14-20.

Reference Type RESULT
PMID: 33708040 (View on PubMed)

Athukorala RP, Jones RD, Sella O, Huckabee ML. Skill training for swallowing rehabilitation in patients with Parkinson's disease. Arch Phys Med Rehabil. 2014 Jul;95(7):1374-82. doi: 10.1016/j.apmr.2014.03.001. Epub 2014 May 9.

Reference Type RESULT
PMID: 24816250 (View on PubMed)

Huckabee ML, McIntosh T, Fuller L, Curry M, Thomas P, Walshe M, McCague E, Battel I, Nogueira D, Frank U, van den Engel-Hoek L, Sella-Weiss O. The Test of Masticating and Swallowing Solids (TOMASS): reliability, validity and international normative data. Int J Lang Commun Disord. 2018 Jan;53(1):144-156. doi: 10.1111/1460-6984.12332. Epub 2017 Jul 5.

Reference Type RESULT
PMID: 28677236 (View on PubMed)

Krishnamurthy R, Kothari S, Balasubramanium RK, Huckabee ML. The Test of Masticating and Swallowing Solids (TOMASS): Normative data for the adult Indian population. Data Brief. 2021 Mar 18;35:106958. doi: 10.1016/j.dib.2021.106958. eCollection 2021 Apr.

Reference Type RESULT
PMID: 33850987 (View on PubMed)

Hughes TA, Wiles CM. Clinical measurement of swallowing in health and in neurogenic dysphagia. QJM. 1996 Feb;89(2):109-16. doi: 10.1093/qjmed/89.2.109.

Reference Type RESULT
PMID: 8729551 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1012

Identifier Type: -

Identifier Source: org_study_id