The Influence of Age and Gender on Tongue Pressure and Swallowing Tongue Pressure (IOPI)

August 4, 2022 updated by: National Taiwan University Hospital
The main topic of the research is to investigate the tongue's strength when swallowing. There has been much foreign literature on tongue strength. Iowa Oral Performance Instrument also has norms for reference, but the data are all taken from non-Asian people such as Caucasians. In this case, the credibility of the norms are decreased in domestic, and we also lack norm data of tongue strength when swallowing. Through the research, we can establish normative data belonging to the domestics, provide usable data for domestic researchers and clinical staff, and explore whether there are differences in age and gender in data between Taiwanese and foreigners.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Swallowing refers to the process by which food enters the stomach from the mouth. It is the physiological mechanism by which humans take in water and nutrients. It is a vital activity for individual survival. The physiological mechanism of swallowing has four major stages, oral preparation, oral cavity, pharynx, and esophagus. Each stage has its physiological mechanism, which depends on the different nerve and muscle structures. In the oral stage, our tongue plays an important role. Whether in the formation or transition of the food bolus, it must rely on the tongue to perform its normal functions. The main topic of the research is to explore the strength of the tongue when swallowing. The purpose is to discuss the influence of gender and age on swallowing tongue pressure. We expect to recruit 80 subjects and divide them into three groups according to their age: 20 to 39 years old, 40 to 59 years old, and 60 to 79 years old, with 13 to 14 males and females in each group, using Iowa Oral Performance Instrument measures the subject's maximum tongue pressure, average swallowing tongue pressure, and the ratio of the maximum tongue pressure used when swallowing, to explore whether age and gender affect tongue strength when swallowing.

Study Type

Observational

Enrollment (Actual)

57

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, +886
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy adult.

Description

Inclusion Criteria:

  • Aged twenty and above.

Exclusion Criteria:

  • Based on self-representation, has the disease of the nervous system, included stroke, brain trauma, Parkinson's disease, dementia, etc.
  • Based on self-representation, has head and neck cancers.
  • Based on self-representation, had any history of swallowing disorders.
  • Based on self-representation, has obvious cognition impairment or language disorder that will affect measure procedure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
20-39Years-old Male
Use Iowa Oral Performance Instrument to measure tongue pressure and swallowing tongue pressure.
Behavioral: Iowa Oral Performance Instrument
Use Iowa Oral Performance Instrument to measure tongue pressure and swallowing tongue pressure
40-59Years-old Male
Use Iowa Oral Performance Instrument to measure tongue pressure and swallowing tongue pressure.
Behavioral: Iowa Oral Performance Instrument
Use Iowa Oral Performance Instrument to measure tongue pressure and swallowing tongue pressure
60-79Years-old Male
Use Iowa Oral Performance Instrument to measure tongue pressure and swallowing tongue pressure.
Behavioral: Iowa Oral Performance Instrument
Use Iowa Oral Performance Instrument to measure tongue pressure and swallowing tongue pressure
20-39Years-old Female
Use Iowa Oral Performance Instrument to measure tongue pressure and swallowing tongue pressure.
Behavioral: Iowa Oral Performance Instrument
Use Iowa Oral Performance Instrument to measure tongue pressure and swallowing tongue pressure
40-59Years-old Female
Use Iowa Oral Performance Instrument to measure tongue pressure and swallowing tongue pressure.
Behavioral: Iowa Oral Performance Instrument
Use Iowa Oral Performance Instrument to measure tongue pressure and swallowing tongue pressure
60-79Years-old Female
Use Iowa Oral Performance Instrument to measure tongue pressure and swallowing tongue pressure.
Behavioral: Iowa Oral Performance Instrument
Use Iowa Oral Performance Instrument to measure tongue pressure and swallowing tongue pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Iowa Oral Performance Instrument
Time Frame: immediately after the intervention/procedure/surgery
Use Iowa Oral Performance Instrument to measure tongue pressure and swallowing tongue pressure of subject, in order to establish Taiwan's data.
immediately after the intervention/procedure/surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Study Director: Yu-Chun Chih, Doctoral, Chung Shan Medical University, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

February 28, 2021

Study Completion (Actual)

April 30, 2021

Study Registration Dates

First Submitted

November 30, 2020

First Submitted That Met QC Criteria

December 6, 2020

First Posted (Actual)

December 8, 2020

Study Record Updates

Last Update Posted (Actual)

August 8, 2022

Last Update Submitted That Met QC Criteria

August 4, 2022

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202010017RINB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Undecided.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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