UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061618 |
|---|---|
| Receipt number | R000070496 |
| Scientific Title | Exploring the Impact of a Usage Monitoring System Integrated into Home Oxigen Therapy on Pulmonary Hypertension Management in Patients with Interstitial Lung Disease |
| Date of disclosure of the study information | 2026/05/18 |
| Last modified on | 2026/05/18 18:11:31 |
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Basic information
Public title
Exploring the Impact of a Usage Monitoring System Integrated into Home Oxigen Therapy on Pulmonary Hypertension Management in Patients with Interstitial Lung Disease
Acronym
HOME-PH in ILD
Scientific Title
Exploring the Impact of a Usage Monitoring System Integrated into Home Oxigen Therapy on Pulmonary Hypertension Management in Patients with Interstitial Lung Disease
Scientific Title:Acronym
HOME-PH in ILD
Region
| Japan |
Condition
Condition
Interstitial Lung Disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the association between HOT adherence and the clinical course of pulmonary hypertension using objective assessments obtained from wearable devices, and to evaluate the utility of a web-based treatment monitoring system for preventive and therapeutic interventions in Group 3 pulmonary hypertension.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Improvement in subjective symptoms
Improvement in exercise capacity assessed using wearable devices
Improvement in BNP levels
Improvement in HOT usage status
Comparison between usage duration during the initial assessment period and subsequent periods
Comparison with activity duration measured by wearable devices
Comparison with pre-study data collected retrospectively
In patients using the DB-400 device, oxygen-related data will also be referenced
Improvement in spirometric parameters
Improvement in nocturnal SpO2
Improvement in inflammatory cytokine profiles
Suppression of worsening TRPG assessed by echocardiography
Improvement in the 6-minute walk test (6MWT)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with interstitial lung disease who are receiving outpatient care at the Department of Respiratory Medicine, Institute of Science Tokyo (including the former Tokyo Medical and Dental University)
Patients who have undergone or are scheduled to undergo echocardiographic examination
Patients who will initiate use of a home oxygen monitoring tool during the study period, or patients already using a home oxygen monitoring tool but who have not previously received physician guidance based on monitoring data and will begin such guidance during the study period
Key exclusion criteria
Patients diagnosed with pulmonary hypertension other than Group 3 (Groups 1, 2, 4, or 5)
Patients strongly suspected of having pulmonary hypertension other than Group 3 (Groups 1, 2, 4, or 5)
Patients who do not provide informed consent for participation in the study
Patients judged by the attending physician to have a prognosis unlikely to allow completion of the study period
Patients unable to attend regular outpatient visits
Patients considered inappropriate for participation by the principal investigator or co-investigators
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tomoya |
| Middle name | |
| Last name | Tateishi |
Organization
Institute of Science Tokyo Hospital
Division name
Department of Respiratory Medicine
Zip code
1130034
Address
Yushima 1-5-45. Bunkyo-ku, Tokyo, Japan
TEL
0358035954
tateishi.pulm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Shiro |
| Middle name | |
| Last name | Sonoda |
Organization
Institute of Science Tokyo Hospital
Division name
Department of Respiratory Medicine
Zip code
113-0034
Address
Yushima 1-5-45. Bunkyo-ku, Tokyo, Japan
TEL
0358035954
Homepage URL
sonoda.shiro@tmd.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
Teijin Pharma Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institute of Science Tokyo Hospital Institutional Review Board
Address
Yushima 1-5-45. Bunkyo-ku, Tokyo, Japan
Tel
0358034575
syomu22.adm@tmd.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 | 05 | Month | 18 | 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 | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a single-center prospective observational study.
In patients with interstitial lung disease, information obtained longitudinally from a home oxygen therapy (HOT) usage monitoring system and wearable devices will be collected to investigate their association with the clinical course of pulmonary hypertension.
Study-specific procedures include wearable device monitoring, questionnaire assessments, and additional blood sampling, while all other examinations and medical management will be performed within the scope of routine clinical practice.
No active therapeutic intervention based on the study protocol will be performed; however, feedback from monitoring data may influence routine clinical counseling and HOT management.
Management information
Registered date
| 2026 | Year | 05 | Month | 18 | Day |
Last modified on
| 2026 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070496
