Status:
UNKNOWN
The Study for Evaluating the Clinical Effectiveness and Safety of Respiratory Rehabilitation Software 'Redpill Breath'(COPD, Asthma, Lung Cancer, Etc.)
Lead Sponsor:
Lifesemantics Corp.
Collaborating Sponsors:
Asan Medical Center
KangWon National University Hospital
Conditions:
Respiratory System Disease
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
19-80 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to prove the clinical superiority of respiratory rehabilitation software "Redpill Breath" and evaluate the clinical improvement effect by 6-minute walk test of the software...
Eligibility Criteria
Inclusion
- 19 to 80 years-old
- Subject who has difficulty in respiratory symptoms and routine with the criteria as below 1) mMRC(modified Medical Research Council Dyspnea Scale) 1 point at least 2) In accordance with Pulmonary function test(PFT/LET/EEG) examined, if there is in one of the following cases as below \[a lung cancer patient\] (FVC or FEV1 \< 80%), \[No lung cancer patient\] (Post-bronchodilator FEV1/FVC \< 0.7) and (Post-bronchodilator FEV1 \< 80%)
- Subject with an Android smartphone (OS 8.0 or higher, internal memory (HDD) of 32GB or higher) or iPhone (iOS 13.0 or higher, internal memory (HDD of 32GB or higher)
- Subject who can use effectively smartphone and mobile software
- Subject who brings their smartphone for a walking test during 12 weeks of the clinical trial.
- Subject who makes the decision voluntarily for participating in the clinical trial and to write their signature to the consent of subject's explanation.
- Subject who complies with the clinical protocol
Exclusion
- Subject who has respiratory distress syndrome, caused by a kind of Neuromuscular disease, Spinal cord injury, Thoracic deformation, etc.
- Subject who participate in respiratory rehabilitation treatment within 6 months of the screening date
- Subject who undergoes respiratory-related symptoms deteriorate within 2 weeks of the screening date to the point where they need additional antibiotics or steroids
- Subject who has an unstable cardiovascular disease (unstable angina pectoris, Acute myocardial infarction, severe coarctation of aorta, etc.)
- a pulmonary arterial hypertension subject
- Subject prescribed physical(e.g. lower-leg joint surgery, neurological limitation) or cognitive factors(e.g. psychical disorder)
- Pregnant or lactating women
- Subject who is unable to read text and tough to communicate
- Subject who has participated in other clinical trials within 90 days of the screening date or participating in other clinical trials.
- Subject who is determined to inappropriate to perform this study according to clinical research associate's opinion(e.g if someone has a bearing on the result of the clinical trial ethically or clinically)
Key Trial Info
Start Date :
January 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05299385
Start Date
January 13 2022
End Date
June 30 2022
Last Update
March 29 2022
Active Locations (3)
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1
Kangwon National University Hospital
Chuncheon, South Korea
2
Asan Medical Center
Seoul, South Korea
3
Kangwon National University Hospital
Seoul, South Korea