UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060124 |
|---|---|
| Receipt number | R000068761 |
| Scientific Title | Detection of Hypoxemia Using Continuous Home SpO2 Monitoring in Patients with Interstitial Lung Disease |
| Date of disclosure of the study information | 2026/01/01 |
| Last modified on | 2025/12/18 18:02:17 |
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Basic information
Public title
Detection of Hypoxemia Using Continuous Home SpO2 Monitoring in Patients with Interstitial Lung Disease
Acronym
ILD-HomeSpO2 Study
Scientific Title
Detection of Hypoxemia Using Continuous Home SpO2 Monitoring in Patients with Interstitial Lung Disease
Scientific Title:Acronym
ILD-HomeSpO2 Study
Region
| Japan |
Condition
Condition
Interstitial Lung Disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the sensitivity of continuous home SpO2 monitoring for detecting hypoxemia indicative of eligibility for home oxygen therapy, compared with the 6-minute walk test.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Sensitivity of continuous home SpO2 monitoring for detecting SpO2 <85%, compared with the 6-minute walk test.
Key secondary outcomes
To examine the association between hypoxemia detected by home SpO2 monitoring and pulmonary function decline or echocardiographic findings suggestive of pulmonary hypertension.
To compare the detection sensitivity of SpO2 <90% between home SpO2 monitoring and the 6-minute walk test.
To assess correlations between home SpO2 monitoring data and patient activity or clinical parameters.
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 aged 20 years or older
Outpatients diagnosed with fibrotic interstitial lung disease and followed at the Department of Respiratory Medicine, Institute of Science Tokyo Hospital
Patients judged by the attending physician to be at potential risk of future disease progression
Patients who do not meet the criteria for initiation of home oxygen therapy at the time of enrollment
Patients who have provided written informed consent to participate in this study
Key exclusion criteria
Patients diagnosed with pulmonary hypertension
Patients whose SpO2 falls below 85% during the 6-minute walk test at the time of enrollment
Patients judged by the attending physician to have a poor prognosis that would preclude completion of the study period
Patients who have difficulty attending regular outpatient visits
Patients deemed unsuitable for participation in the study by the principal investigator or sub-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 | Tomoya |
| Middle name | |
| Last name | Tateishi |
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
tateishi.pulm@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 | 01 | Month | 01 | 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
| 2025 | Year | 12 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2027 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an exploratory prospective observational study using a clinically approved home SpO2 monitoring device for diagnostic support only. No therapeutic intervention is involved, and initiation of home oxygen therapy is determined as part of standard clinical care.
Management information
Registered date
| 2025 | Year | 12 | Month | 18 | Day |
Last modified on
| 2025 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068761
