Exploratory Clinical Trial: Low Frequency Therapy for Interstitial Pneumonia

Phase 2

Recruiting

• Conditions: interstitial pneumonia

• Registration Number: JPRN-jRCT1012230026
• Lead Sponsor: Konno satoshi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-07-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

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.

Exclusion Criteria

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.

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Study & Design

• Study Type: Interventional
• Study Design: Not specified