PresbyphagiaPhase 3NCT07080996
Effect of Biofeedback Tongue Strengthening Program on Tongue Pressure and Swallowing Performance
A Phase 3 study testing Strengthening training with biofeedback and Endurance training with biofeedback in people with Presbyphagia and Abnormal Tongue Pressure, run by Mahidol University at 1 site in Thailand.
Trial summary
Aging is often accompanied by a decline in bodily functions, including the swallowing process. Tongue-strengthening exercises have been shown to improve tongue strength and thickness in healthy adults and the elderly, thereby supporting swallowing function. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Presbyphagia, Abnormal Tongue Pressure
- What is being tested?
- Strengthening training with biofeedback and Endurance training with biofeedback
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteThailand
- Study dates
- 25 Mar 2025to 24 Mar 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 60 years or older.
- No cognitive impairment, as screened by the Mini-Mental State Examination (MMSE) with a score of 24 or higher.
- Elderly with abnormal tongue pressure have an anterior maximum isometric tongue pressure (MIP) average of less than 30 kilopascals.
Who cannot join
- Diagnosed with head and neck cancers, a neurological disorder, or other conditions that affect the tongue muscle strength and training.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site
Faculty of Physical Therapy, Mahidol University
Salaya, Changwat Nakhon Pathom, 73170
About this study
Official title: Effect of Biofeedback Tongue Strengthening Program on Tongue Pressure and Swallowing Performance in Elderly With Abnormal Tongue Pressure
Aging is often accompanied by a decline in bodily functions, including the swallowing process. Tongue-strengthening exercises have been shown to improve tongue strength and thickness in healthy adults and the elderly, thereby supporting swallowing function. Consistent exercise is key to preventing muscle weakness and preserving their ability to swallow. However, there is limited research on the effects of tongue-strengthening exercises that explores varying intensities and repetitions in elderly with impaired tongue pressure. Consequently, the objective of this study is to investigate the effect of biofeedback tongue strengthening program on tongue pressure and swallowing performance in elderly with abnormal tongue pressure. The results will serve as valuable data for selecting effective interventions to improve tongue strength and swallowing.
Read the detailed description
Sample size calculation: A sample size of 52 participants was determined for this study, accounting for a 20% dropout rate. The calculation was performed using G*Power software (version 3.1.7), based on an effect size of 0.87. This value was derived from a previous study by Van den Steen et al. (21), which measured the difference in mean tongue pressure strength between training and control groups. With an effect size of 0.87, considered a large effect, a minimum of 44 participants was required to achieve 80% statistical power at a significance level of 0.05. Statistical analysis: IBM SPSS Statistics will be used for all data analysis. A chi-squared test and Mann-Whitney U test will be performed to compare the baseline characteristics of participants between the two groups. A two-way ANOVA will be used to analyze differences between the two groups (strengthening training and endurance training) across the three time points (Baseline, Post-test after one day, and Post-test after one month). Subsequently, a Wilcoxon signed-rank test will be used to identify significant changes within each group at each time point.
- Conditions
- Presbyphagia, Abnormal Tongue Pressure
- Being tested
- Strengthening training with biofeedback, Endurance training with biofeedback
- Keywords
- Elderly, Presbyphagia, Dysphagia, Tongue Pressure, Biofeedback
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strengthening training with biofeedbackCombination product
Participants in this group trained their tongue strength with the Iowa Oral Performance Instrument (IOPI), completing 3 sets of 10 repetitions at 80% of their maximum.
Endurance training with biofeedbackCombination product
Participants in this group trained their tongue endurance with the Iowa Oral Performance Instrument (IOPI), completing 3 sets of 20 repetitions at 60% of their maximum.
| Study group | Role | What they receive |
|---|---|---|
| Strengthening training group | Experimental | Participants trained their tongue strength three times a week for four weeks. Receives: Combination Product: Strengthening training with biofeedback |
| Endurance training group | Active comparator | Participants trained their tongue endurance three times a week for four weeks. Receives: Combination Product: Endurance training with biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tongue pressure
The Iowa Oral Performance Instrument (IOPI Medical LCC, Redmond, WA USA) was used to measure maximum anterior and posterior tongue pressure, as well as tongue pressure during swallowing.
Measured: Baseline, Post-test after one day of training, Post-test after one month of training
Eating Assessment Tool-10 (EAT-10) score
The EAT-10 is used to assess swallowing difficulties. The 10 items are scored from 0 to 4, with higher scores indicating more severe dysphagia.
Measured: Baseline, Post-test after one day of training, Post-test after one month of training
Functional Oral Intake Scale (FOIS)
The FOIS is a 7-point ordinal scale describing the functional level of oral intake of food and liquids.
Measured: Baseline, Post-test after one day of training, Post-test after one month of training
Mann Assessment of Swallowing Ability (MASA) score
The MASA is a standardized clinical swallowing examination, specifically developed as a diagnostic test for the presence of oropharyngeal dysphagia. The total score of the MASA is 200 points and the cutoff value is 177 points. The results of the MASA are interpreted as no abnormality (≥178), mild dysphagia (168-177), moderate dysphagia (139-167), and severe dysphagia (≤138).
Measured: Baseline, Post-test after one day of training, Post-test after one month of training
Water swallowing test
The Water Swallow Test is a clinical instrument designed to assess swallowing function. A participant is seated and provided with a cup containing 150 mL of water at a standard temperature. The total time required to ingest the liquid is then recorded.
Measured: Baseline, Post-test after one day of training, Post-test after one month of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start25 Mar 2025
- Primary completion24 Feb 2026 (estimated)
- Study completion24 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for PresbyphagiaStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All participants are randomly assigned to either the strengthening training or endurance training group using a computer.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Surachart Thongchoomsin, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07080996
- Sponsor's protocol ID
- MU-CIRB 2025/037.2201
- Status last verified
- Jul 2025
- First submitted
- 15 Jul 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will share IPD when we receive the consent from participants.
Publications
Nakao Y, Yamashita T, Honda K, Katsuura T, Hama Y, Nakamura Y, Ando K, Ishikura R, Kodama N, Uchiyama Y, Domen K. Association Among Age-Related Tongue Muscle Abnormality, Tongue Pressure, and Presbyphagia: A 3D MRI Study. Dysphagia. 2021 Jun;36(3):483-491. doi: 10.1007/s00455-020-10165-4. Epub 2020 Aug 2.
PubMed 32743742Hsiao HL, Lou JH, Wang CC, Lai YJ, Wu SJ, Hwu YJ. Effects of Tongue-Strengthening Exercise on Tongue Strength Reserve and Detraining Effects among Healthy Adults: A Randomized Controlled Trial. Int J Environ Res Public Health. 2022 Jun 4;19(11):6878. doi: 10.3390/ijerph19116878.
PubMed 35682461Feng HY, Zhang PP, Wang XW. Presbyphagia: Dysphagia in the elderly. World J Clin Cases. 2023 Apr 16;11(11):2363-2373. doi: 10.12998/wjcc.v11.i11.2363.
PubMed 37123321Sarve 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.
PubMed 33708040Park HJ, Jung EH, Kim SM, Park SC, Jo MJ, Lee YS, Kim SH, Han SY. Assessment of oral hypofunction and its association with age among Korean community-dwelling older adults. BMC Oral Health. 2024 Apr 10;24(1):441. doi: 10.1186/s12903-024-04180-2.
PubMed 38600517Yano J, Nagami S, Yokoyama T, Nakamura K, Kobayashi M, Odan Y, Hikasa M, Hanayama K, Fukunaga S. Effects of Tongue-Strengthening Self-Exercises in Healthy Older Adults: A Non-Randomized Controlled Trial. Dysphagia. 2021 Oct;36(5):925-935. doi: 10.1007/s00455-020-10216-w. Epub 2020 Nov 19.
PubMed 33215265Sakamoto Y, Oyama G, Umeda M, Funahara M, Soutome S, Nakamura W, Kojima Y, Iwai H. Effect of decreased tongue pressure on dysphagia and survival rate in elderly people requiring long-term care. J Dent Sci. 2022 Apr;17(2):856-862. doi: 10.1016/j.jds.2021.09.031. Epub 2021 Oct 7.
PubMed 35756815Fei T, Polacco RC, Hori SE, Molfenter SM, Peladeau-Pigeon M, Tsang C, Steele CM. Age-related differences in tongue-palate pressures for strength and swallowing tasks. Dysphagia. 2013 Dec;28(4):575-81. doi: 10.1007/s00455-013-9469-6. Epub 2013 May 16.
PubMed 23677389Matsuo K, Palmer JB. Coordination of Mastication, Swallowing and Breathing. Jpn Dent Sci Rev. 2009 May 1;45(1):31-40. doi: 10.1016/j.jdsr.2009.03.004.
PubMed 20161022Kamarunas E, Murray K, Drulia T, Szynkiewicz S, Griffin L, Mulheren R. Biofeedback and Exercise Load Affect Accuracy of Tongue Strength Exercise Performance. Dysphagia. 2025 Apr;40(2):489-500. doi: 10.1007/s00455-024-10751-w. Epub 2024 Aug 18.
PubMed 39154305Silva JO, Giglio LD, Trawitzki LVV. Effects of tongue strengthening exercises in healthy adults and elderly: an integrative literature review. Codas. 2023 Jun 5;35(3):e20210213. doi: 10.1590/2317-1782/20232021213pt. eCollection 2023.
PubMed 37283365Smaoui S, Langridge A, Steele CM. The Effect of Lingual Resistance Training Interventions on Adult Swallow Function: A Systematic Review. Dysphagia. 2020 Oct;35(5):745-761. doi: 10.1007/s00455-019-10066-1. Epub 2019 Oct 14.
PubMed 31612288Takahashi C, Iwasaki M, Motokawa K, Watanabe Y, Hayakawa M, Mikami Y, Shirobe M, Inagaki H, Edahiro A, Ohara Y, Hirano H, Shinkai S, Awata S. Factors Predicting Tongue Pressure Decline among Community-Dwelling Older Adults: The Takashimadaira Study. Int J Environ Res Public Health. 2022 Jun 26;19(13):7850. doi: 10.3390/ijerph19137850.
PubMed 35805508Yoshikawa M, Fukuoka T, Mori T, Hiraoka A, Higa C, Kuroki A, Takeda C, Maruyama M, Yoshida M, Tsuga K. Comparison of the Iowa Oral Performance Instrument and JMS tongue pressure measurement device. J Dent Sci. 2021 Jan;16(1):214-219. doi: 10.1016/j.jds.2020.06.005. Epub 2020 Jun 10.
PubMed 33384800McKenna VS, Zhang B, Haines MB, Kelchner LN. A Systematic Review of Isometric Lingual Strength-Training Programs in Adults With and Without Dysphagia. Am J Speech Lang Pathol. 2017 May 17;26(2):524-539. doi: 10.1044/2016_AJSLP-15-0051.
PubMed 28282484
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Biofeedback Tongue Strengthening Program on Tongue Pressure and Swallowing Performance in Elderly With Abnormal Tongue Pressure
- ClinicalTrials.gov ID
- NCT07080996
- Acronym / sponsor ID
- MU-CIRB 2025/037.2201
- Conditions
- Presbyphagia, Abnormal Tongue Pressure
- Keywords
- Elderly, Presbyphagia, Dysphagia, Tongue Pressure, Biofeedback
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 24 Feb 2026 (estimated)
- Study completion
- 24 Mar 2026 (estimated)
- First posted
- 23 Jul 2025 (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.
Aging is often accompanied by a decline in bodily functions, including the swallowing process. Tongue-strengthening exercises have been shown to improve tongue strength and thickness in healthy adults and the elderly, thereby supporting swallowing function. Consistent exercise is key to preventing muscle weakness and preserving their ability to swallow. However, there is limited research on the effects of tongue-strengthening exercises that explores varying intensities and repetitions in elderly with impaired tongue pressure. Consequently, the objective of this study is to investigate the effect of biofeedback tongue strengthening program on tongue pressure and swallowing performance in elderly with abnormal tongue pressure. The results will serve as valuable data for selecting effective interventions to improve tongue strength and swallowing.
Detailed description
Sample size calculation: A sample size of 52 participants was determined for this study, accounting for a 20% dropout rate. The calculation was performed using G*Power software (version 3.1.7), based on an effect size of 0.87. This value was derived from a previous study by Van den Steen et al. (21), which measured the difference in mean tongue pressure strength between training and control groups. With an effect size of 0.87, considered a large effect, a minimum of 44 participants was required to achieve 80% statistical power at a significance level of 0.05. Statistical analysis: IBM SPSS Statistics will be used for all data analysis. A chi-squared test and Mann-Whitney U test will be performed to compare the baseline characteristics of participants between the two groups. A two-way ANOVA will be used to analyze differences between the two groups (strengthening training and endurance training) across the three time points (Baseline, Post-test after one day, and Post-test after one month). Subsequently, a Wilcoxon signed-rank test will be used to identify significant changes within each group at each time point.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- All participants are randomly assigned to either the strengthening training or endurance training group using a computer.
| Arm | Type | Receives |
|---|---|---|
| Strengthening training group | Experimental | Combination Product: Strengthening training with biofeedbackParticipants trained their tongue strength three times a week for four weeks. |
| Endurance training group | Active comparator | Combination Product: Endurance training with biofeedbackParticipants trained their tongue endurance three times a week for four weeks. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 60 years or older.
- No cognitive impairment, as screened by the Mini-Mental State Examination (MMSE) with a score of 24 or higher.
- Elderly with abnormal tongue pressure have an anterior maximum isometric tongue pressure (MIP) average of less than 30 kilopascals.
Key exclusion criteria (1 listed)
- Diagnosed with head and neck cancers, a neurological disorder, or other conditions that affect the tongue muscle strength and training.
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 |
|---|---|---|
| Strengthening training with biofeedbackParticipants in this group trained their tongue strength with the Iowa Oral Performance Instrument (IOPI), completing 3 sets of 10 repetitions at 80% of their maximum. | Combination product | Strengthening training group |
| Endurance training with biofeedbackParticipants in this group trained their tongue endurance with the Iowa Oral Performance Instrument (IOPI), completing 3 sets of 20 repetitions at 60% of their maximum. | Combination product | Endurance training group |
Primary outcome
Tongue pressure
Time frame: Baseline, Post-test after one day of training, Post-test after one month of training
The Iowa Oral Performance Instrument (IOPI Medical LCC, Redmond, WA USA) was used to measure maximum anterior and posterior tongue pressure, as well as tongue pressure during swallowing.
Eating Assessment Tool-10 (EAT-10) score
Time frame: Baseline, Post-test after one day of training, Post-test after one month of training
The EAT-10 is used to assess swallowing difficulties. The 10 items are scored from 0 to 4, with higher scores indicating more severe dysphagia.
Functional Oral Intake Scale (FOIS)
Time frame: Baseline, Post-test after one day of training, Post-test after one month of training
The FOIS is a 7-point ordinal scale describing the functional level of oral intake of food and liquids.
Mann Assessment of Swallowing Ability (MASA) score
Time frame: Baseline, Post-test after one day of training, Post-test after one month of training
The MASA is a standardized clinical swallowing examination, specifically developed as a diagnostic test for the presence of oropharyngeal dysphagia. The total score of the MASA is 200 points and the cutoff value is 177 points. The results of the MASA are interpreted as no abnormality (≥178), mild dysphagia (168-177), moderate dysphagia (139-167), and severe dysphagia (≤138).
Water swallowing test
Time frame: Baseline, Post-test after one day of training, Post-test after one month of training
The Water Swallow Test is a clinical instrument designed to assess swallowing function. A participant is seated and provided with a cup containing 150 mL of water at a standard temperature. The total time required to ingest the liquid is then recorded.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Background: PubMed 32743742Nakao Y, Yamashita T, Honda K, Katsuura T, Hama Y, Nakamura Y, Ando K, Ishikura R, Kodama N, Uchiyama Y, Domen K. Association Among Age-Related Tongue Muscle Abnormality, Tongue Pressure, and Presbyphagia: A 3D MRI Study. Dysphagia. 2021 Jun;36(3):483-491. doi: 10.1007/s00455-020-10165-4. Epub 2020 Aug 2.
- Background: PubMed 35682461Hsiao HL, Lou JH, Wang CC, Lai YJ, Wu SJ, Hwu YJ. Effects of Tongue-Strengthening Exercise on Tongue Strength Reserve and Detraining Effects among Healthy Adults: A Randomized Controlled Trial. Int J Environ Res Public Health. 2022 Jun 4;19(11):6878. doi: 10.3390/ijerph19116878.
- Background: PubMed 37123321Feng HY, Zhang PP, Wang XW. Presbyphagia: Dysphagia in the elderly. World J Clin Cases. 2023 Apr 16;11(11):2363-2373. doi: 10.12998/wjcc.v11.i11.2363.
- Background: PubMed 33708040Sarve 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.
- Background: PubMed 38600517Park HJ, Jung EH, Kim SM, Park SC, Jo MJ, Lee YS, Kim SH, Han SY. Assessment of oral hypofunction and its association with age among Korean community-dwelling older adults. BMC Oral Health. 2024 Apr 10;24(1):441. doi: 10.1186/s12903-024-04180-2.
- Background: PubMed 33215265Yano J, Nagami S, Yokoyama T, Nakamura K, Kobayashi M, Odan Y, Hikasa M, Hanayama K, Fukunaga S. Effects of Tongue-Strengthening Self-Exercises in Healthy Older Adults: A Non-Randomized Controlled Trial. Dysphagia. 2021 Oct;36(5):925-935. doi: 10.1007/s00455-020-10216-w. Epub 2020 Nov 19.
- Background: PubMed 35756815Sakamoto Y, Oyama G, Umeda M, Funahara M, Soutome S, Nakamura W, Kojima Y, Iwai H. Effect of decreased tongue pressure on dysphagia and survival rate in elderly people requiring long-term care. J Dent Sci. 2022 Apr;17(2):856-862. doi: 10.1016/j.jds.2021.09.031. Epub 2021 Oct 7.
- Background: PubMed 23677389Fei T, Polacco RC, Hori SE, Molfenter SM, Peladeau-Pigeon M, Tsang C, Steele CM. Age-related differences in tongue-palate pressures for strength and swallowing tasks. Dysphagia. 2013 Dec;28(4):575-81. doi: 10.1007/s00455-013-9469-6. Epub 2013 May 16.
- Background: PubMed 20161022Matsuo K, Palmer JB. Coordination of Mastication, Swallowing and Breathing. Jpn Dent Sci Rev. 2009 May 1;45(1):31-40. doi: 10.1016/j.jdsr.2009.03.004.
- Background: PubMed 39154305Kamarunas E, Murray K, Drulia T, Szynkiewicz S, Griffin L, Mulheren R. Biofeedback and Exercise Load Affect Accuracy of Tongue Strength Exercise Performance. Dysphagia. 2025 Apr;40(2):489-500. doi: 10.1007/s00455-024-10751-w. Epub 2024 Aug 18.
- Background: PubMed 37283365Silva JO, Giglio LD, Trawitzki LVV. Effects of tongue strengthening exercises in healthy adults and elderly: an integrative literature review. Codas. 2023 Jun 5;35(3):e20210213. doi: 10.1590/2317-1782/20232021213pt. eCollection 2023.
- Background: PubMed 31612288Smaoui S, Langridge A, Steele CM. The Effect of Lingual Resistance Training Interventions on Adult Swallow Function: A Systematic Review. Dysphagia. 2020 Oct;35(5):745-761. doi: 10.1007/s00455-019-10066-1. Epub 2019 Oct 14.
- Individual participant dataSharing planned: Undecided. We will share IPD when we receive the consent from participants.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Strengthening training with biofeedback and Endurance training with biofeedback in people with Presbyphagia and Abnormal Tongue Pressure, run by Mahidol University at 1 site in Thailand.
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 3 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 28 Jul 2025. 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 Thailand. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Tongue pressure (time frame: Baseline, Post-test after one day of training, Post-test after one month of training). The study lists 5 primary outcomes in all. 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 NCT07080996, which also lists 34 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 28 Jul 2025.