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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009301
Receipt No. R000010916
Scientific Title Association between sleep apnea syndrome and hypertension/endocrine disorders
Date of disclosure of the study information 2012/11/11
Last modified on 2012/11/09

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Basic information
Public title Association between sleep apnea syndrome and hypertension/endocrine disorders
Acronym SAS-HTN/Endo study
Scientific Title Association between sleep apnea syndrome and hypertension/endocrine disorders
Scientific Title:Acronym SAS-HTN/Endo study
Region
Japan

Condition
Condition sleep apnea syndrome, hypertension, metabolic syndrome
Classification by specialty
Medicine in general Pneumology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the association between sleep apnea syndrome and hypertension, and to elucidate common causative endocrine factors for two diseases.
Basic objectives2 Others
Basic objectives -Others To identify factors, especially endocrine factors, which underlie two mutually-related diseases, sleep apnea syndrome and hypertension.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes blood pressure after therapy for sleep apnea syndrome (nCPAP)
Key secondary outcomes Parameters for sleep disorders including AHI, parameters for metabolic disorders including BMI, plasma glucose, and continuous glucose monitoring, parameters for endocrine disorders including plasma/urinary aldosterone and catecholamines etc.

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients with insomnia, apnea, hypertension, or obesity-related diseases etc.
Key exclusion criteria patients with renal dysfunction (Cr>or=3.0)
Target sample size 100

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Koichi Fukunaga
Organization Keio university school of medicine
Division name internal medicine (respiratory)
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-5363-3793
Email

Public contact
1st name of contact person
1st name
Middle name
Last name
Organization Keio university school of medicine
Division name internal medicine (respiratory)
Zip code
Address
TEL 03-5363-3793
Homepage URL
Email

Sponsor
Institute Keio university school of medicine
Institute
Department

Funding Source
Organization Keio university school of medicine
Organization
Division
Category of Funding Organization Self funding
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
2012 Year 11 Month 11 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
2012 Year 07 Month 25 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We obseave parameters related sleep apnea, hypertension, and endocrine disorders in diagnosis and treatment process. We subsequently analyse them.

Management information
Registered date
2012 Year 11 Month 09 Day
Last modified on
2012 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010916

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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