UMIN-CTR Clinical Trial

Basic information
Public title	Validation of a new tele-monitoring modality (TeleOX) in patients with chronic obstructive pulmonary disease
Acronym	Validation of the performance of TeleOX
Scientific Title	Validation of a new tele-monitoring modality (TeleOX) in patients with chronic obstructive pulmonary disease
Scientific Title:Acronym	Validation of the performance of TeleOX
Region	Japan

Condition
Condition	Chronic obstructive pulmonary disease
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 chronic obstructive pulmonary disease
Basic objectives2	Others
Basic objectives -Others	To compare the respiratory rate measured by TeleOX and by polysomnography
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Correlation between the respiratory rates measured by TeleOX and those measured by polysomnography during wakefulness and sleep
Key secondary outcomes	1.Changes of respiratory rate and percutaneous carbon dioxide partial pressure by oxygen administration 2.Correlation between percutaneous oxygen saturation or percutaneous carbon dioxide partial pressure and data evaluated by transthoracic echocardiography 3.Correlation between respiratory rate and other clinical characteristics

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 chronic obstructive pulmonary disease followed at the Department of Respiratory Medicine in Kyoto University Hospital, and suspected to have 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 chronic obstructive pulmonary disease 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
Email	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
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)

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
Email	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	2018 Year 09 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	10
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	No longer recruiting
Date of protocol fixation	2018 Year 09 Month 10 Day
Date of IRB	2018 Year 12 Month 18 Day
Anticipated trial start date	2018 Year 12 Month 19 Day
Last follow-up date	2021 Year 12 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study is a prospective observational study in patients with chronic obstructive pulmonary diesase.

Management information
Registered date	2018 Year 09 Month 10 Day
Last modified on	2020 Year 09 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038847

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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