UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of factors contributing to the impairment of sleep quality in chronic respiratory disease.
Title of the study (Brief title)	Sleep quality in respiratory disease.
Region	Japan

Condition
Condition	Chronic respiratory disease showing respiratory dysfunction
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The first purpose in this study is to clarify whether the quality of sleep is deteriorated or not in chronic respiratory disease showing respiratory dysfunction.
Basic objectives2	Others
Basic objectives -Others	The second purpose in this study is to analyze the factors contributing to the deterioration in chronic respiratory disease showing dysfunction.
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Sleep fragmentation
Key secondary outcomes	Stability of parasympathetic nerve function.

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	45 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with chronic respiratory disease such as chronic obstructive pulmonary disease, pulmonary fibrosis, pulmonary tuberculosis sequelae, bronchiectasis, chronic bronchitis, having respiratory dysfunction of obstructive ventilatory dysfunction or constrictive ventilatory dysfunction, and healthy control subjects without chronic respiratory disease, respiratory dysfunction, and sleep disturbance.
Key exclusion criteria	The patients who had moderate to severe arrhythmia, atrial fibrillation, peripheral circulatory failure, conspicuous heart failure, renal failure, impaired cognitive function or those who had suffered from respiratory tract infection or exacerbation of COPD during the preceding three months, and those who had been treated with narcotic agents due to insomnia are excluded.
Target sample size	100

Research contact person
Name of lead principal investigator	Keisaku Fujimoto
Organization	Shinshu University school of Health Sciences
Division name	Department of Clinical Laboratory Sciences
Address	3-1-1, Asahi, Matsumoto, Nagano, 390-8621, Japan
TEL	0263-37-2393
Email	keisaku@shinshu-u.ac.jp

Public contact
Name of contact person	Keisaku Fujimoto
Organization	Shinshu University school of Health Sciences
Division name	Department of Clinical Laboratory Sciences
Address	3-1-1, Asahi, Matsumoto, Nagano, 390-8621, Japan
TEL	0263-37-2393
Homepage URL
Email	keisaku@shinshu-u.ac.jp

Sponsor
Institute	Shinshu University School of Health Sciences
Institute
Department

Funding Source
Organization	Shinshu University School of Health Sciences
Organization
Division
Category of Funding Organization	Self funding
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

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 30 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2017 Year 08 Month 08 Day
Anticipated trial start date	2017 Year 08 Month 30 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	Partially published
URL releasing results
Results
Other related information	none

Management information
Registered date	2017 Year 08 Month 30 Day
Last modified on	2017 Year 08 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033079