UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052421 |
|---|---|
| Receipt number | R000059835 |
| Scientific Title | Observational study on dyspnea associated with mask-wearing and the effect of mask-wearing on respiratory function |
| Date of disclosure of the study information | 2023/10/05 |
| Last modified on | 2024/04/05 10:03:36 |
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Basic information
Public title
Research on the effect of wearing a mask on dyspnea on exertion
Acronym
Research on the effect of wearing a mask on dyspnea on exertion
Scientific Title
Observational study on dyspnea associated with mask-wearing and the effect of mask-wearing on respiratory function
Scientific Title:Acronym
Observational study on dyspnea associated with mask-wearing and the effect of mask-wearing on respiratory function
Region
| Japan |
Condition
Condition
chronic respiratory diseases
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To quantify the dyspnea associated with wearing masks in patients with chronic respiratory conditions by utilizing an established questionnaire and to analyze how the intensity of dyspnea correlates with the patients' respiratory function
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dyspnea evaluated with Multidimensional Dyspnea Profile
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
The Multidimensional Dyspnea Profile is first evaluated about the dyspnea while walking with a mask on and then about the dyspnea while without a mask.
Interventions/Control_2
The Multidimensional Dyspnea Profile is first evaluated about the dyspnea while walking without a mask and then about the dyspnea while with a mask on.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with respiratory disease attending the outpatient department of respiratory medicine at Kyoto University Hospital
Key exclusion criteria
Patients unable to complete a written medical questionnaire or give informed consent
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Isao |
| Middle name | |
| Last name | Ito |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Respiratory Medicine
Zip code
606-8507
Address
54 Shogoin-Kawaharacho, Sakyo, Kyoto, 606-8507, Japan
TEL
075-751-3830
konai@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Isao |
| Middle name | |
| Last name | Ito |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Respiratory Medicine
Zip code
606-8507
Address
54 Shogoin-Kawaharacho, Sakyo, Kyoto, 606-8507, Japan
TEL
075-751-3830
Homepage URL
konai@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
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 606-8501, JAPAN
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
| 2023 | Year | 10 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.rmed.2023.107453
Number of participants that the trial has enrolled
35
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
Main results already published
Date of protocol fixation
| 2021 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 05 | Day |
Last modified on
| 2024 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059835
