UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060425 |
|---|---|
| Receipt number | R000068497 |
| Scientific Title | Effects of differences in response speed of breath-synchronized function of HiSanso Portable alfa II on improving oxygenation during six-minute walk test: Crossover trial |
| Date of disclosure of the study information | 2026/01/21 |
| Last modified on | 2026/01/21 16:14:20 |
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Basic information
Public title
Effects of differences in response speed of breath-synchronized function of HiSanso Portable alfa II on improving oxygenation during six-minute walk test
Acronym
Effects of differences in response speed of breath-synchronized function of HiSanso Portable alfa II on improving oxygenation during six-minute walk test
Scientific Title
Effects of differences in response speed of breath-synchronized function of HiSanso Portable alfa II on improving oxygenation during six-minute walk test: Crossover trial
Scientific Title:Acronym
Effects of differences in response speed of breath-synchronized function of HiSanso Portable alfa II on improving oxygenation during six-minute walk test: Crossover trial
Region
| Japan |
Condition
Condition
interstitial lung disease and chronic obstructive pulmonary disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether improving the response speed of the respiratory synchronization function in the respiratory synchronizer of HiSanso Portable alfa II contributes to improving oxygenation during six-minute walk test
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Difference in the change from pre-test SpO2 to post-test minimum SpO2 between the standard and modified versions of the respiratory synchronization function during the six-minute walk test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
A modified version of the respiratory synchronizer with improved response speed for its respiratory synchronization function is used.
Interventions/Control_2
A respiratory synchronizer with standard respiratory synchronization functionality is used.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Drug therapy is not restricted.
2. Cases with interstitial lung disease or chronic obstructive pulmonary disease.
3. Cases using home oxygen therapy during exertion or with a minimum SpO2 below 90% during six-minute walk test performed in room air.
Key exclusion criteria
1. Cases with acute exacerbation or respiratory tract infection within the past four weeks, resulting in instability.
2. Cases with new pneumothorax within the past four weeks, resulting in instability.
3. Cases with unstable angina or myocardial infarction within the past four weeks.
4. Cases with chronic pneumothorax.
5. Cases with worsening of complications such as heart failure, bronchial asthma, or renal failure, resulting in instability.
6. Cases unable to perform the six-minute walk test due to dyspnea or similar reasons.
7. Cases requiring nasal oxygen flow exceeding 5 L/min during exertion.
8. Cases with peripheral circulatory disorders making SpO2 measurement difficult.
9. Other cases deemed inappropriate by the study investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Toyohiro |
| Middle name | |
| Last name | Hirai |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Respiratory Medicine
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3830
t_hirai@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Hamada |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Advanced Medicine for Respiratory Failure
Zip code
606-8507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-366-7689
Homepage URL
sh1124@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Toyohiro Hirai
Funding Source
Organization
Teijin Pharma Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Ayabe City Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 19 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 21 | Day |
Last modified on
| 2026 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068497
