UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047098 |
|---|---|
| Receipt number | R000053726 |
| Scientific Title | Assessment of pulmonary function by time-of-flight sensor in patients with respiratory disease |
| Date of disclosure of the study information | 2022/03/07 |
| Last modified on | 2025/05/22 22:35:10 |
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Basic information
Public title
Assessment of pulmonary function by time-of-flight sensor in patients with respiratory disease
Acronym
Time-of-flight sensor for respiratory disease
Scientific Title
Assessment of pulmonary function by time-of-flight sensor in patients with respiratory disease
Scientific Title:Acronym
Time-of-flight sensor for respiratory disease
Region
| Japan |
Condition
Condition
Airway stenosis, BA, Chronic obstructive pulmonary disease (COPD), sleep apnea syndrome (SAS) and mechanical ventilation for respiratory failure, interstitial pneumonia, relapsing polychondritis
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of a time-of-flight sensor in patents with respiratory disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The correlation between percent predicted forced expiratory volume in one second by spirometer and the motion of the thorax in 1 second by time-of-flight sensor.
Key secondary outcomes
Assessment of ventilation distribution by measuring the motion of the thorax divided into six regions, the left upper, left middle, left lower, right upper, right middle and right lower.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Assessment of percent predicted forced expiratory volume in one second using a time-of-flight sensor
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
1. Men and women over 20 years old.
2. Outpatients or hospitalized patients with chronic obstructive pulmonary disease (COPD), bronchial asthma, sleep apnea syndrome (SAS), mechanical ventilation for respiratory failure and a control of healthy multidisciplinary healthcare workers with no history of respiratory diseases.
3. All subjects agreed to participate in this study and gave written informed consent.
Key exclusion criteria
1. Subjects who are or suspected to be pregnant.
2. Patients with fever and with worsening respiratory symptoms within 2 weeks.
3. Any other cases regarded as inadequate for study enrollment by the investigators.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Masamichi |
| Middle name | |
| Last name | Mineshita |
Organization
St. Marianna University School of
Medicine
Division name
Division of Respiratory Medicine, Department of Internal Medicine
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Japan
TEL
044-977-8111
m-mine@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Nishine |
Organization
St. Marianna University School of Medicine
Division name
Division of Respiratory Medicine, Department of Internal Medicine
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Japan
TEL
044-977-8111
Homepage URL
h2nishine@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo Metropolitan University
University of Electro-Communications
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Marianna University School of Medicine, Division of Graduate Student Affairs and Research Promotion
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Japan 216-8511
Tel
044-977-8111
k-sienbu.mail@marianna-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
| 2022 | Year | 03 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 02 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 10 | 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
| 2022 | Year | 03 | Month | 07 | Day |
Last modified on
| 2025 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053726
