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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000021825
Receipt No. R000025149
Scientific Title The association among sleep disturbance focusing on sleep related breathing disorders at home, daily activity and parameters of lifestyle disease
Date of disclosure of the study information 2016/05/01
Last modified on 2019/02/27

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Basic information
Public title The association among sleep disturbance focusing on sleep related breathing disorders at home, daily activity and parameters of lifestyle disease
Acronym The association among sleep disturbance focusing on sleep related breathing disorders at home, daily activity and parameters of lifestyle disease
Scientific Title The association among sleep disturbance focusing on sleep related breathing disorders at home, daily activity and parameters of lifestyle disease
Scientific Title:Acronym 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
1st name
Middle name
Last name Kazuo Chin
Organization Graduate school of medicine, Kyoto University
Division name Department of Respiratory Care and Sleep Control Medicine
Zip code
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
1st name
Middle name
Last name Takuma Minami
Organization Graduate school of medicine, Kyoto University
Division name Respiratory medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Terminated
Date of protocol fixation
2016 Year 03 Month 29 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000025149

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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