臨床研究等提出・公開システム

Development of a New Swallowing Maneuver and Assessment of Its Effects Using High-Resolution Manometry

Development and Evaluation of a New Swallowing Exercise

Yoichiro Aoyagi

1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan

y.aoyagi@nms.ac.jp

Miho Ohashi

Nippon Medical School Hospital

1-1-5 Sendagi, Bunkyo-ku, Tokyo, Japan

+81-3-3822-2131

m-ohashi@nms.ac.jp

Recruiting

April. 25, 2024

Interventional

single arm study

open(masking not used)

no treatment control/standard of care control

parallel assignment

treatment purpose

Healthy subjects with normal swallowing function
Individuals aged 20 years or older with normal swallowing function who have provided informed consent after receiving an explanation of this study using the explanatory document.

Patients with dysphagia
Patients with dysphagia aged 20 years or older who meet the following criteria:
1. Stable general condition.
2. Are inpatients or outpatients in the Department of Rehabilitation at Nippon Medical School Hospital, OR patients visiting the Department of Swallowing and Dysphagia Rehabilitation at Tokyo Medical and Dental University Hospital.
3. Have provided informed consent after receiving an explanation of this study using the explanatory document.

Healthy subjects with normal swallowing function (Exclusion Criteria) Individuals who meet any of the following criteria:
1. Individuals with a history of stroke, neuromuscular diseases (e.g., Parkinson disease, spinocerebellar degeneration, amyotrophic lateral sclerosis, Guillain-Barre syndrome, muscular dystrophy), organic pharyngolaryngeal diseases (diseases causing abnormalities in the throat due to inflammation, cancer, etc.), respiratory diseases, or upper gastrointestinal (esophagus or stomach) diseases.
2, Individuals with subjective symptoms suggestive of dysphagia, such as discomfort during swallowing.
3. Individuals otherwise judged inappropriate for participation in this study by the principal investigator or sub-investigator.

Patients with dysphagia (Exclusion Criteria) Patients who meet any of the following criteria:
1. Patients whose general condition is unstable.
2. Patients who have difficulty understanding instructions.
3. Patients judged to have severe dysphagia preventing oral intake (Clinical Severity Scale for Dysphagia: Grade 2 (Food aspiration) or below).
4. Patients otherwise judged inappropriate for participation in this study by the principal investigator or sub-investigator.

Both

Patients with swallowing functional impairments and normal subjects

With a high-resolution manometry (HRM) catheter inserted transnasally into the esophagus, participants will swallow thickened water in designated postures (a total of 22 swallows). This procedure will be used to evaluate how pharyngeal and esophageal motility changes in each posture.

Pharyngeal and esophageal contraction and relaxation pressure

Swallowing Risk Index

+81-3-3822-2131

April. 25, 2024

No

none