臨床研究等提出・公開システム

Exploratory Clinical Trial: Low Frequency Therapy for Interstitial Pneumonia

Exploratory Clinical Trial: Low Frequency Therapy for Interstitial Pneumonia

Konno satoshi

Hokkaido University Hospital

Kita14, Nishi5, Kita-Ku, Sapporo Hokkaido

satkonno@pop.med.hokudai.ac.jp

Yuichi Kojima

Hokkaido University Hospital

Kita14, Nishi5, Kita-Ku, Sapporo Hokkaido

+81-11-706-5911

yu1.kojima@pop.med.hokudai.ac.jp

Recruiting

July. 29, 2023

Interventional

single arm study

open(masking not used)

historical control

single assignment

treatment purpose

Patients with interstitial pneumonia who are attending or being admitted to Hokkaido University Hospital (Respiratory Medicine) between the date of approval for implementation and January 31, 2028.
Patients who meet all of the following criteria are eligible.
(i) Patients who are 18 years of age or older at the time of informed consent.
(ii) Patients who have been clinically diagnosed as having interstitial pneumonia by chest imaging or respiratory function tests, whose arterial partial pressure of oxygen at rest is less than 70 Torr or less than 80 Torr, and whose SpO2 drops to less than 90% in a 6-minute walk test.
(iii) Subjects with subjective symptoms such as shortness of breath or dyspnea.
(iv) After receiving a thorough explanation of their participation in this study, participants must be able to actively understand the consent document and give written consent of their own free will.

Patients with any one of the following conditions shall be excluded
(i) Patients who have had acute heart failure, myocardial infarction, pulmonary edema, or acute exacerbation of interstitial pneumonia within the past 3 months
(ii) Patients with a history of progressive brain lesions
(iii) Patients receiving concomitant vagus nerve stimulation therapy
(iv) Patients with a history of epilepsy
(5) Patients with a history of severe cardiovascular disease
(vi) Patients with pneumothorax
(vii) Patients with uncontrolled infection
(viii) Pregnant or lactating
(ix) Patients with skin hypersensitivity and a history of skin symptoms caused by metal or other substances
(x) Those who have difficulty in oral intake
(xi) Patients with severe renal dysfunction (estimated glomerular filtration rate (eGFR) less than 30 ml/min)
(xii) Patients with a cardiac pacemaker or an implantable cardioverter-defibrillator
(xiii) Other subjects who are deemed inappropriate as research subjects by the principal investigator or research coordinator.

Translated with www.DeepL.com/Translator (free version)

interstitial pneumonia

Stimulation/treatment with low-frequency therapy equipment

Progression of respiratory insufficiency, as assessed by respiratory function tests, following low-frequency therapy. Progression of respiratory failure is defined as a decrease in effort lung capacity of 5% or more, taking into consideration the PF-ILD criteria.

(i) Improvement rate of exercise tolerance as assessed by MRC breathlessness scale, modified Borg scale, 6-minute walk test, and arterial blood gas analysis during the observation period.
(ii) Safety of infrasound therapy and occurrence of adverse events.
(iii) Change in QOL before and after infrasound therapy (based on K-BILD)
(iv) Acute exacerbation during infrasound therapy

+81-11-706-7636

Aug. 16, 2023

Yes

none