Swallowing DisorderIOPINCT04658316
The Influence of Age and Gender on Tongue Pressure and Swallowing Tongue Pressure
An observational study of Swallowing Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Swallowing Disorder
- What is being tested?
- Iowa Oral Performance Instrument
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 57 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2020to 30 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adult.
Who may be able to join
- Aged twenty and above.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Swallowing Disorder
- Being tested
- Iowa Oral Performance Instrument
- Keywords
- Swallowing function, Age, Gender
- Medical subject headings
- Deglutition Disorders, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iowa Oral Performance InstrumentBehavioural
Use Iowa Oral Performance Instrument to measure tongue pressure and swallowing tongue pressure
| Study group | Role | What they receive |
|---|---|---|
| 20-39Years-old Male | Use Iowa Oral Performance Instrument to measure tongue pressure and swallowing tongue pressure. Receives: Behavioral: Iowa Oral Performance Instrument | |
| 40-59Years-old Male | Use Iowa Oral Performance Instrument to measure tongue pressure and swallowing tongue pressure. Receives: Behavioral: Iowa Oral Performance Instrument | |
| 60-79Years-old Male | Use Iowa Oral Performance Instrument to measure tongue pressure and swallowing tongue pressure. Receives: Behavioral: Iowa Oral Performance Instrument | |
| 20-39Years-old Female | Use Iowa Oral Performance Instrument to measure tongue pressure and swallowing tongue pressure. Receives: Behavioral: Iowa Oral Performance Instrument | |
| 40-59Years-old Female | Use Iowa Oral Performance Instrument to measure tongue pressure and swallowing tongue pressure. Receives: Behavioral: Iowa Oral Performance Instrument | |
| 60-79Years-old Female | Use Iowa Oral Performance Instrument to measure tongue pressure and swallowing tongue pressure. Receives: Behavioral: Iowa Oral Performance Instrument |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iowa Oral Performance Instrument
Use Iowa Oral Performance Instrument to measure tongue pressure and swallowing tongue pressure of subject, in order to establish Taiwan's data.
Measured: immediately after the intervention/procedure/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start1 Dec 2020
- Primary completion28 Feb 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Swallowing DisorderStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Chun Chih, Doctoral, Study director, Chung Shan Medical University, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04658316
- Sponsor's protocol ID
- 202010017RINB
- Acronym
- IOPI
- Status last verified
- Nov 2020
- First submitted
- 30 Nov 2020
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided.
Publications
張家臻, 陳惠櫻, 李蕙蓉, 林宗豪, 謝佩君, 張雁雲, & 邱麗玲. (2018). 國 際吞嚥困難飲食標準中文繁體版本. 亞東學報, (38), 1-18.
Adams V, Mathisen B, Baines S, Lazarus C, Callister R. A systematic review and meta-analysis of measurements of tongue and hand strength and endurance using the Iowa Oral Performance Instrument (IOPI). Dysphagia. 2013 Sep;28(3):350-69. doi: 10.1007/s00455-013-9451-3. Epub 2013 Mar 7.
PubMed 23468283Alsanei, W. A. S. (2015). Tongue Pressure-A Key Limiting Aspect in Bolus Swallowing (Doctoral dissertation, University of Leeds).
Crow HC, Ship JA. Tongue strength and endurance in different aged individuals. J Gerontol A Biol Sci Med Sci. 1996 Sep;51(5):M247-50. doi: 10.1093/gerona/51a.5.m247.
PubMed 8808997Logemann, J. A. (1998). Evaluation and Treatment of Swallowing Disorders (2nd ed.). Austin, TX: Pro-Ed.
Park JS, You SJ, Kim JY, Yeo SG, Lee JH. Differences in orofacial muscle strength according to age and sex in East Asian healthy adults. Am J Phys Med Rehabil. 2015 Sep;94(9):677-86. doi: 10.1097/PHM.0000000000000230.
PubMed 25415391Robinovitch SN, Hershler C, Romilly DP. A tongue force measurement system for the assessment of oral-phase swallowing disorders. Arch Phys Med Rehabil. 1991 Jan;72(1):38-42.
PubMed 1985622Robbins J, Kays SA, Gangnon RE, Hind JA, Hewitt AL, Gentry LR, Taylor AJ. The effects of lingual exercise in stroke patients with dysphagia. Arch Phys Med Rehabil. 2007 Feb;88(2):150-8. doi: 10.1016/j.apmr.2006.11.002.
PubMed 17270511Stierwalt JA, Youmans SR. Tongue measures in individuals with normal and impaired swallowing. Am J Speech Lang Pathol. 2007 May;16(2):148-56. doi: 10.1044/1058-0360(2007/019).
PubMed 17456893Vanderwegen J, Guns C, Van Nuffelen G, Elen R, De Bodt M. The influence of age, sex, bulb position, visual feedback, and the order of testing on maximum anterior and posterior tongue strength and endurance in healthy belgian adults. Dysphagia. 2013 Jun;28(2):159-66. doi: 10.1007/s00455-012-9425-x. Epub 2012 Sep 16.
PubMed 22983359Vitorino J. Effect of age on tongue strength and endurance scores of healthy Portuguese speakers. Int J Speech Lang Pathol. 2010 Jun;12(3):237-43. doi: 10.3109/17549501003746160.
PubMed 20433342Youmans SR, Youmans GL, Stierwalt JA. Differences in tongue strength across age and gender: is there a diminished strength reserve? Dysphagia. 2009 Mar;24(1):57-65. doi: 10.1007/s00455-008-9171-2. Epub 2008 Aug 9.
PubMed 18690406
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Age and Gender on Tongue Pressure and Swallowing Tongue Pressure
- ClinicalTrials.gov ID
- NCT04658316
- Acronym / sponsor ID
- IOPI / 202010017RINB
- Conditions
- Swallowing Disorder
- Keywords
- Swallowing function, Age, Gender
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 8 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 20-39Years-old Male | – | Behavioral: Iowa Oral Performance InstrumentUse Iowa Oral Performance Instrument to measure tongue pressure and swallowing tongue pressure. |
| 40-59Years-old Male | – | Behavioral: Iowa Oral Performance InstrumentUse Iowa Oral Performance Instrument to measure tongue pressure and swallowing tongue pressure. |
| 60-79Years-old Male | – | Behavioral: Iowa Oral Performance InstrumentUse Iowa Oral Performance Instrument to measure tongue pressure and swallowing tongue pressure. |
| 20-39Years-old Female | – | Behavioral: Iowa Oral Performance InstrumentUse Iowa Oral Performance Instrument to measure tongue pressure and swallowing tongue pressure. |
| 40-59Years-old Female | – | Behavioral: Iowa Oral Performance InstrumentUse Iowa Oral Performance Instrument to measure tongue pressure and swallowing tongue pressure. |
| 60-79Years-old Female | – | Behavioral: Iowa Oral Performance InstrumentUse Iowa Oral Performance Instrument to measure tongue pressure and swallowing tongue pressure. |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adult.
Key inclusion criteria (1 listed)
- Aged twenty and above.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Iowa Oral Performance InstrumentUse Iowa Oral Performance Instrument to measure tongue pressure and swallowing tongue pressure | Behavioural | 20-39Years-old Female, 20-39Years-old Male, 40-59Years-old Female, 40-59Years-old Male, 60-79Years-old Female, 60-79Years-old Male |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
- Background張家臻, 陳惠櫻, 李蕙蓉, 林宗豪, 謝佩君, 張雁雲, & 邱麗玲. (2018). 國 際吞嚥困難飲食標準中文繁體版本. 亞東學報, (38), 1-18.
- Background: PubMed 23468283Adams V, Mathisen B, Baines S, Lazarus C, Callister R. A systematic review and meta-analysis of measurements of tongue and hand strength and endurance using the Iowa Oral Performance Instrument (IOPI). Dysphagia. 2013 Sep;28(3):350-69. doi: 10.1007/s00455-013-9451-3. Epub 2013 Mar 7.
- BackgroundAlsanei, W. A. S. (2015). Tongue Pressure-A Key Limiting Aspect in Bolus Swallowing (Doctoral dissertation, University of Leeds).
- Background: PubMed 8808997Crow HC, Ship JA. Tongue strength and endurance in different aged individuals. J Gerontol A Biol Sci Med Sci. 1996 Sep;51(5):M247-50. doi: 10.1093/gerona/51a.5.m247.
- BackgroundLogemann, J. A. (1998). Evaluation and Treatment of Swallowing Disorders (2nd ed.). Austin, TX: Pro-Ed.
- Background: PubMed 25415391Park JS, You SJ, Kim JY, Yeo SG, Lee JH. Differences in orofacial muscle strength according to age and sex in East Asian healthy adults. Am J Phys Med Rehabil. 2015 Sep;94(9):677-86. doi: 10.1097/PHM.0000000000000230.
- Background: PubMed 1985622Robinovitch SN, Hershler C, Romilly DP. A tongue force measurement system for the assessment of oral-phase swallowing disorders. Arch Phys Med Rehabil. 1991 Jan;72(1):38-42.
- Background: PubMed 17270511Robbins J, Kays SA, Gangnon RE, Hind JA, Hewitt AL, Gentry LR, Taylor AJ. The effects of lingual exercise in stroke patients with dysphagia. Arch Phys Med Rehabil. 2007 Feb;88(2):150-8. doi: 10.1016/j.apmr.2006.11.002.
- Background: PubMed 17456893Stierwalt JA, Youmans SR. Tongue measures in individuals with normal and impaired swallowing. Am J Speech Lang Pathol. 2007 May;16(2):148-56. doi: 10.1044/1058-0360(2007/019).
- Background: PubMed 22983359Vanderwegen J, Guns C, Van Nuffelen G, Elen R, De Bodt M. The influence of age, sex, bulb position, visual feedback, and the order of testing on maximum anterior and posterior tongue strength and endurance in healthy belgian adults. Dysphagia. 2013 Jun;28(2):159-66. doi: 10.1007/s00455-012-9425-x. Epub 2012 Sep 16.
- Background: PubMed 20433342Vitorino J. Effect of age on tongue strength and endurance scores of healthy Portuguese speakers. Int J Speech Lang Pathol. 2010 Jun;12(3):237-43. doi: 10.3109/17549501003746160.
- Background: PubMed 18690406Youmans SR, Youmans GL, Stierwalt JA. Differences in tongue strength across age and gender: is there a diminished strength reserve? Dysphagia. 2009 Mar;24(1):57-65. doi: 10.1007/s00455-008-9171-2. Epub 2008 Aug 9.
- Individual participant dataSharing planned: Undecided. Undecided.
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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.
Yu-Chun Chih, Doctoral study director
Chung Shan Medical University, Taiwan
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 Swallowing Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
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 4 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 8 Aug 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Iowa Oral Performance Instrument (time frame: immediately after the intervention/procedure/surgery). 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 NCT04658316, which also lists 12 linked publications.
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 8 Aug 2022.