UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023012 |
|---|---|
| Receipt number | R000026526 |
| Scientific Title | The prognosis in the patients with sleep disordered breathing |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2018/01/04 23:12:21 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The prognosis in the patients with sleep disordered breathing
Acronym
Prognosis in sleep apnea patients
Scientific Title
The prognosis in the patients with sleep disordered breathing
Scientific Title:Acronym
Prognosis in sleep apnea patients
Region
| Japan |
Condition
Condition
sleep disordered breathing
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation for the prognosis in sleep disordered breathing patients.
Basic objectives2
Others
Basic objectives -Others
Observational study in SDB patients and investigation of prognositif factors, comorbidity.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, unknown type of stoke, miyocardial infarction,angina pectoris, heart failure, aortic diseases and sudden death.Time to caridiac events from diagnosis of SDB.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who visited the Sleep Apnea
Syndrome Outpatient Department of the St. Marianna University School of Medicine Hospital.
Key exclusion criteria
The patients were lost to follow-up.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | HIROMITSU SEKIZUKA |
Organization
St. Marianna University School of Medicine
Division name
Division of Cardiology, Department of Internal Medicine
Zip code
Address
2-16-1, Sugao Miyamae-ku, Kawasaki-city, Kanagawa, 216-8511, Japan.
TEL
044-977-8111
sekimal@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | HIROMITSU SEKIZUKA |
Organization
St. Marianna University School of Medicine
Division name
Division of Cardiology, Department of Internal Medicine
Zip code
Address
2-16-1, Sugao Miyamae-ku, Kawasaki-city, Kanagawa, 216-8511, Japan.
TEL
044-977-8111
Homepage URL
sekimal@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
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 | 09 | 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 | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | 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
None
Management information
Registered date
| 2016 | Year | 07 | Month | 04 | Day |
Last modified on
| 2018 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026526
