UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009301
Receipt number 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 15:57:39

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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

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

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 or person

Institute

Keio university school of medicine

Institute

Department

Personal name



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

Value
https://center6.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