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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016150
Receipt No. R000018745
Scientific Title The follow-up evaluation of physical function and complication in obstructive sleep apnea patients
Date of disclosure of the study information 2015/01/07
Last modified on 2018/01/23

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Basic information
Public title The follow-up evaluation of physical function and complication in obstructive sleep apnea patients
Acronym The follow-up evaluation of physical function and complication in obstructive sleep apnea patients
Scientific Title The follow-up evaluation of physical function and complication in obstructive sleep apnea patients
Scientific Title:Acronym The follow-up evaluation of physical function and complication in obstructive sleep apnea patients
Region
Japan

Condition
Condition obstructive sleep apnea
Classification by specialty
Medicine in general Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the changes of the muscle strength, muscle mass, physical performance, autonomic function and arterial sclerosis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1)polysomnography
2)muscle strength, muscle mass, physical performance
3)comprehensive geriatric assessment
4)autonomic function
Key secondary outcomes 1)pulse wave velocity
2)blood pressure variability, pulse wave variability
3)index of oxidative stress
4)plasma IGF-1, IL-6

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

Not applicable
Gender Male and Female
Key inclusion criteria The patients with obstructive sleep apnea
Key exclusion criteria The subjects found offensove by attending physicians for this research
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norihisa Ito
Organization Osaka university graduate school of medicine
Division name The department of geriatric medicine and nephrology
Zip code
Address 2-2, Yamadaoka, Suita. Osaka, Japan
TEL 06-6879-3852
Email itoh@geriat.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Norihisa Ito
Organization Osaka university graduate school of medicine
Division name The department of geriatric medicine and nephrology
Zip code
Address 2-2, Yamadaoka, Suita. Osaka, Japan
TEL 06-6879-3852
Homepage URL
Email itoh@geriat.med.osaka-u.ac.jp

Sponsor
Institute Osaka university graduate school of medicine
The department of geriatric medicine and nephrology
Institute
Department

Funding Source
Organization Osaka university graduate school of medicine
The department of geriatric medicine and nephrology
Organization
Division
Category of Funding Organization Other
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
2015 Year 01 Month 07 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 Open public recruiting
Date of protocol fixation
2015 Year 01 Month 07 Day
Date of IRB
Anticipated trial start date
2015 Year 01 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective cohort study to assess the changes of the muscle strength, muscle mass, physical performance, activities of daily living, cognitive function, autonomic function and arterial sclerosis in random sample

Management information
Registered date
2015 Year 01 Month 07 Day
Last modified on
2018 Year 01 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018745

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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