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Search / Trial NCT07080996

Effect of Biofeedback Tongue Strengthening Program on Tongue Pressure and Swallowing Performance

Launched by MAHIDOL UNIVERSITY · Jul 15, 2025

Trial Information

Current as of September 30, 2025

Enrolling by invitation

Keywords

Elderly Presbyphagia Dysphagia Tongue Pressure Biofeedback

ClinConnect Summary

This study is testing whether a tongue-strengthening program with real-time feedback can improve tongue strength and swallowing in older adults who have weaker tongue muscles. People aged 60 and older with abnormal tongue pressure (anterior maximum tongue pressure averaging less than 30 kPa) are eligible. Participants are randomly assigned to either a strengthening training group or an endurance training group, both using biofeedback and conducted three times a week for four weeks. The trial is double-blind, so neither participants nor the people assessing the results know which training group each person is in. Exclusion criteria include head or neck cancer, certain neurological conditions, or other issues that could affect tongue strength. The study is at Mahidol University in Salaya, Thailand, and plans to enroll about 52 participants.

Participants will have tongue strength and swallowing tests at baseline, after one day of training, and after one month. They will use the Iowa Oral Performance Instrument (IOPI) to measure tongue pressure, and complete several swallowing-related measures: EAT-10 (a symptom questionnaire), FOIS (how well they can eat and drink), MASA (a swallowing assessment), and a water swallowing test. Results are not yet available, and the study is currently enrolling with an estimated completion around March 2026. IPD sharing is undecided.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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.
  • Exclusion Criteria:
  • Diagnosed with head and neck cancers, a neurological disorder, or other conditions that affect the tongue muscle strength and training.

About Mahidol University

Mahidol University, a premier institution in Thailand, is dedicated to advancing healthcare through innovative research and education. As a leading sponsor of clinical trials, the university leverages its extensive expertise in medical and health sciences to facilitate rigorous scientific investigations aimed at improving patient care and public health outcomes. With a commitment to ethical practices and collaboration, Mahidol University fosters multidisciplinary approaches, engaging a diverse array of researchers and healthcare professionals to drive meaningful advancements in clinical research.

Locations

Salaya, Nakhon Pathom, Thailand

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported