UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014932 |
|---|---|
| Receipt number | R000017375 |
| Scientific Title | Sleep Disordered Breathing and Depression in Patients with Cardiovascular Diseases |
| Date of disclosure of the study information | 2014/09/01 |
| Last modified on | 2016/08/24 12:40:33 |
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Basic information
Public title
Sleep Disordered Breathing and Depression in Patients with Cardiovascular Diseases
Acronym
Sleep Disordered Breathing and Depression in Patients with Cardiovascular Diseases
Scientific Title
Sleep Disordered Breathing and Depression in Patients with Cardiovascular Diseases
Scientific Title:Acronym
Sleep Disordered Breathing and Depression in Patients with Cardiovascular Diseases
Region
| Japan |
Condition
Condition
cardiovascular disease (CVD)
Depression
sleep disordered breathing (SDB)
sleep disorder
Classification by specialty
| Cardiology | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine prevalence of sleep disordered breathing and depression in patients with cardiovascular diseases
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
prevalence of sleep disordered breathing and depression in patients with cardiovascular diseases
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients who consecutively admitted in the department of cardiology of a university hospital
2) Patients with informed concent
Key exclusion criteria
1) Patients with dementia/mental retardation
2) Patients in a state of shock
3) Patients with disturbance of consciousness
4) Patients on a ventilator
5) Patients who are considerded unsuitable for the trial by attending physician
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nozomu Kotorii |
Organization
Kurume University school of medicine
Division name
Department of Neuropsychiatry
Zip code
Address
67 Asahi-machi, Kurume, Fukuoka, Japan
TEL
+81-942-31-7564
kotorii_nozomu@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nozomu Kotorii |
Organization
Kurume University school of medicine
Division name
Department of Neuropsychiatry
Zip code
Address
67 Asahi-machi, Kurume, Fukuoka, Japan
TEL
+81-942-31-7564
Homepage URL
kotorii_nozomu@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University school of medicine, Department of Neuropsychiatry
Institute
Department
Personal name
Funding Source
Organization
Health, Labour and Welfare Ministry
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2014 | 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
Completed
Date of protocol fixation
| 2010 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2015 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
All patients routinely completed a comprehensive questionnaires that included question about QOL (EQ-5D), sleep habits (PSQI), subjective sleepiness (Epworth Sleepiness Scale), and depression (Patient Health Questionnaire-9). All patients were evaluated for SDB using pulse oximeter (PULSOX-Me300, Japan, Osaka) and were performed echocardiography. Furthermore, full polysomnography are performed simultaneously with pulse oximetry measurement to patients that an agreement is provided.
Management information
Registered date
| 2014 | Year | 08 | Month | 23 | Day |
Last modified on
| 2016 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017375
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
