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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032941
Receipt No. R000037549
Official scientific title of the study 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 2018/06/11

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Basic information
Official scientific title of the study Validation of a new tele-monitoring modality (TeleOX) in patients with
interstitial pneumonias
Title of the study (Brief title) 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 Tomohiro Handa
Organization Graduate School of Medicine, Kyoto University
Division name Department of Advanced Medicine for Respiratory Failure
Address 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL 075-366-7689
Email hanta@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person Tomohiro Handa
Organization Graduate School of Medicine, Kyoto University
Division name Department of Advanced Medicine for Respiratory Failure
Address 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL 075-366-7689
Homepage URL
Email hanta@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Advanced Medicine for Respiratory Failure, Graduate School of Medicine, Kyoto University
Institute
Department

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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 06 Month 10 Day
Anticipated trial start date
2018 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
2018 Year 06 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037549

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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