UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The association among sleep disturbance focusing on sleep related breathing disorders at home, daily activity and parameters of lifestyle disease
Title of the study (Brief title)	The association among sleep disturbance focusing on sleep related breathing disorders at home, daily activity and parameters of lifestyle disease
Region	Japan

Condition
Condition	Obstructive sleep apnea (OSA)
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To explore the association and the influence to lifestyle disease between daily activity of patients suspected to have sleep related breathing disorders and sleep disturbance focusing on sleep apnea.
Basic objectives2	Others
Basic objectives -Others	To validate the measurement of sleep time by actiwatch2 compared to PSG for patients with sleep related breathing disorder.
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The association among sleep disturbance focusing on sleep related breathing disorders at home, daily activity and parameters of lifestyle disease
Key secondary outcomes	To validate the measurement of sleep duration by Actiwatch 2 compared with PSG according to severity of sleep related breathing disorders. To validate that UW-301BT can measure sleep disturbance including sleep duration and daily activity, compared with Actiwatch 2 and Lifecorder. To explore the association among following items, OSA severity, sleep duration and daily activity 1) 3%ODI measured by Pulsox and Actiwatch 2 or UW-301BT 2) Sleep disturbance and activity measured by Actiwatch 2 and UW-301BT 3) Physical activity measured by Lifecorder and UW-301BT 4) Body weight and body composition 5) Sleep quality 6) Questionaires 7) Laboratory tests and urinalysis 8) Arterial blood gases 9) Visceral fat 10) Electrocardiography 11) Lung function test 12) Chest X ray 13) Vascular endothelial function measured by Endo-PAT

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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who agree with this study
Key exclusion criteria	# Patients who are suspected to have other sleep related breathing disorders except for OSA and scheduled to undergo PSG # Patients have difficulty with wearing measuring equipment due to dementia, physically handicapped, and so on # Patients who is considered as unfit by a main researcher
Target sample size	100

Research contact person
Name of lead principal investigator	Kazuo Chin
Organization	Graduate school of medicine, Kyoto University
Division name	Department of Respiratory Care and Sleep Control Medicine
Address	54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan
TEL	075-751-3852
Email	chink@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Takuma Minami
Organization	Graduate school of medicine, Kyoto University
Division name	Respiratory medicine
Address	Shogoin Kawahara-cho 54, Sakyo-ku, Kyoto
TEL	075-751-3830
Homepage URL
Email	t.373@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Graduate school of medicine, Kyoto University
Institute
Department

Funding Source
Organization	Ministry of Health, Labor, and Welfare of Japan
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2016 Year 05 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 03 Month 29 Day
Anticipated trial start date	2016 Year 04 Month 18 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	Cross-sectional study ; descriptive epidemiology Patients suspected to have OSA equip Lifecorder, Actiwatch 2 and UW-301BT the whole day and keep a sleep diary consecutive for 7 days. They also equip Pulsox during sleep for 2 days to measure Oxygen desaturation index; ODI. If patients have the indication of polysomnography from the 3% ODI, they do one night PSG in the hospital with Actiwatch 2 and Pulsox. They have usual laboratory tests and urinalysis.

Management information
Registered date	2016 Year 04 Month 07 Day
Last modified on	2019 Year 02 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025149