UMIN-CTR Clinical Trial

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037549