UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032941 |
|---|---|
| Receipt number | R000037549 |
| Scientific Title | Validation of a new tele-monitoring modality (TeleOX) in patients with interstitial pneumonias |
| Date of disclosure of the study information | 2018/06/11 |
| Last modified on | 2020/12/13 20:24:46 |
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Basic information
Public title
Validation of a new tele-monitoring modality (TeleOX) in patients with
interstitial pneumonias
Acronym
Validation of the performance of
TeleOX
Scientific Title
Validation of a new tele-monitoring modality (TeleOX) in patients with
interstitial pneumonias
Scientific Title:Acronym
Validation of the performance of
TeleOX
Region
| Japan |
Condition
Condition
Interstitial pneumonia
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the accuracy of respiratory rate measurement by TeleOX during wakefulness and sleep in patients with interstitial pneumonias
Basic objectives2
Others
Basic objectives -Others
To analyze the correlation between the respiratory rate measured by TeleOX and that measured polysomnography
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation of the respiratory rate measured by TeleOX and that measured by polysomnography during wakefulness and sleep
Key secondary outcomes
1.Prevalence and severity of sleep related breathing disorders and sleep quality evaluated by questionnaires, including Pittsburg Sleep Quality Index, Japanese version of Epworth Sleepiness Scale, and Japanese version of the Athens Insomnia Scale, in patients with interstitial pneumonias
2.Changes of respiratory rate and percutaneous carbon dioxide partial pressure by oxygen administration
3.Correlation of clinical characteristics and quality of life evaluated by questionnaires, including modified MRC dyspnea scale, Hospital Anxiety and Depression Scale, Idiopathic pulmonary fibrosis-St.Geroge's Respiratory Questionnaire, and Short-Form 36
4.Correlation of percutaneous oxygen saturation and percutaneous carbon dioxide partial pressure and pulmonary arterial pressure measured by transthoracic echocardiography
5.Correlation between clinical characteristics and physical activity evaluated by Actiwatch
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Male or female patients aged 20-85 years
2.Treatment drugs do not matter.
3.Patients with interstitial pneumonias followed at the Department of Respiratory Medicine in Kyoto University Hospital
4.Patients with suspected sleep-related breathing disorders by the examination with pulse-oximeter (PULSOX-300i) or Watch-PAT in the setting of outpatient clinic
Key exclusion criteria
1.Patients are excluded if they are in active phase of acute exacerbation of interstitial pneumonia or respiratory infections; new onset pneumothorax or exacerbation of chronic pneumothorax; or unstable state due to the worsening of other comorbidities (e.g. heart failure, bronchial asthma, and renal failure).
2.Patients are excluded if they are already treated with nasal continuous positive airway pressure therapy for obstructive sleep apnea syndrome.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Handa |
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
hanta@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Handa |
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
hanta@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Advanced Medicine for Respiratory Failure, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
TEIJIN PHARMA
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
Kyoto University Graduate School and Faculty of Medicine Kyoto University Hospital Ethics Committe
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
京都大学医学部附属病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 11 | 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
19
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
Completed
Date of protocol fixation
| 2018 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 08 | Day |
Date of closure to data entry
| 2020 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
This study is a prospective observational study in patients with interstitial pneumonia.
Management information
Registered date
| 2018 | Year | 06 | Month | 11 | Day |
Last modified on
| 2020 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037549
