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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028067
Receipt No. R000032135
Scientific Title Longitudinl association between sleep disordered breathing and metabolic risk factors
Date of disclosure of the study information 2017/07/05
Last modified on 2017/07/04

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Basic information
Public title Longitudinl association between sleep disordered breathing and metabolic risk factors
Acronym sleep apnea and metabolic risk factors
Scientific Title Longitudinl association between sleep disordered breathing and metabolic risk factors
Scientific Title:Acronym sleep apnea and metabolic risk factors
Region
Japan

Condition
Condition Obesity diabetes hypertension
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify whether the presence of sleep disordered-breathing associates with incidental hypertension and diabetes independently of BMI
Basic objectives2 Others
Basic objectives -Others To clarify the deterioration of sleep disorderd breathing in subjects with AHI 5-20.
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of diabetes, hypertension, and the progression of sleep-apnea
Key secondary outcomes

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
30 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria middle-aged Japanese men and women who voluntarily received a test for polysomnography at health check-ups.
Key exclusion criteria those who had measurements on polysomnography less than 5 hours.
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Oka Rie
Organization Kanazawa University Hospital
Division name Cardiovascular and Internal Medicine
Zip code
Address 13-1 Takara-machi, Kanazawa
TEL 076-265-2264
Email ririoka@goo.jp

Public contact
Name of contact person
1st name
Middle name
Last name Oka Rie
Organization Kanazawa University Hospital
Division name Cardiovascular and Internal Medicine
Zip code
Address 13-1 Takara-machi, Kanazawa
TEL 076-265-2264
Homepage URL
Email ririoka@goo.jp

Sponsor
Institute Hokuriku Central Hospital
Institute
Department

Funding Source
Organization Hokuriku CentrlHhospital
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
2017 Year 07 Month 05 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 Enrolling by invitation
Date of protocol fixation
2015 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Historical cohort study using data of medical health check-ups

Management information
Registered date
2017 Year 07 Month 04 Day
Last modified on
2017 Year 07 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032135

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2018/01/20 fanal1173data.xlsx


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