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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 30, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 8, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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