筋萎縮性側索硬化症における肺吸気能訓練と呼吸機能

基本情報

NCT ID

NCT07257302

ステータス

募集中

試験のフェーズ

該当なし

試験タイプ

介入

目標被験者数

15

治験依頼者名

National Center of Neurology and Psychiatry, Japan

概要

The goal of this clinical trial is to learn whether lung insufflation capacity (LIC) training can help maintain respiratory function and prolong survival in people with amyotrophic lateral sclerosis (ALS). The main questions it aims to answer are: * Does early and continuous LIC training slow the decline in forced vital capacity (FVC)? * Does LIC training delay the need for tracheostomy or noninvasive ventilation (NIV)? This single-center study at the National Center of Neurology and Psychiatry (NCNP) in Japan will enroll 15 adults with ALS, diagnosed according to the El Escorial or Awaji criteria. Participants will: * Use the LIC Trainer device to perform lung insufflation training twice daily at home * Visit the clinic every 3 months for respiratory and functional assessments * Have lung tests, including FVC, LIC, maximum insufflation capacity (MIC), cough peak flow (CPF), and complete the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) There is no control group within this trial; researchers will compare results with matched historical controls from the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) database.

対象疾患

介入

依頼者（Sponsor）

実施施設 (1)