UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012093 |
|---|---|
| Receipt number | R000014130 |
| Scientific Title | Investigation of biomarkers of fatigue for sleep disorders |
| Date of disclosure of the study information | 2013/10/21 |
| Last modified on | 2019/04/25 11:54:56 |
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Basic information
Public title
Investigation of biomarkers of fatigue for sleep disorders
Acronym
Investigation of biomarkers of fatigue for sleep disorders
Scientific Title
Investigation of biomarkers of fatigue for sleep disorders
Scientific Title:Acronym
Investigation of biomarkers of fatigue for sleep disorders
Region
| Japan |
Condition
Condition
Obstructive sleep apnea syndrome
Classification by specialty
| Psychiatry | Laboratory medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate correlations of fatigue related factors in blood and saliva with severity of obstructive sleep apnea syndrome.
Basic objectives2
Others
Basic objectives -Others
Clinical characteristics
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessments of severity of obstructive sleep apnea syndrome and fatigue related factors in blood and saliva samples.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Drawing blood, questionnaires and medical interview
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing overnight polysomnography at the Jikei University School of Medicine on suspicion of obstructive sleep apnea syndrome.
Key exclusion criteria
Lack of ability to consent, people judged not suitable by doctor.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Kondo |
Organization
The Jikei University School of Medicine
Division name
Department of Virology
Zip code
105-8461
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo 105-8461, Japan
TEL
03-3433-1111
kkondo@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Kobayashi |
Organization
The Jikei University School of Medicine
Division name
Department of Psychiatry
Zip code
105-8461
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo 105-8461, Japan
TEL
03-3433-1111
Homepage URL
kobayashi-n@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
Japan Tobacco Inc.
IRB Contact (For public release)
Organization
the Ethics Committees of the Jikei University School of Medicine
Address
3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo 105-8461, Japan
Tel
03-3433-1111
rinri@jikei.ac.jp
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
東京慈恵会医科大学附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 21 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S0006291X16311251?via%3Dihub
Publication of results
Partially published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S0006291X16311251?via%3Dihub
Number of participants that the trial has enrolled
62
Results
As compared to the normal controls (NCs), no significant change in salivary human herpesvirus (HHV-) 6 DNA copy numbers was observed in the obstructive sleep apnea syndrome (OSAS) groups. Copy numbers of HHV-7 DNA were lower in the OSAS groups than in NCs.
No significant correlations were observed between HHV-6 and HHV-7 DNA copy numbers and apnea-hypopnea index (AHI) in the OSAS groups.
Results date posted
| 2019 | Year | 04 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2016 | Year | 09 | Month | 09 | Day |
Baseline Characteristics
6 females, 36 males
age 49.8 +- 1.7 [mean +- s.e.m.]
Participant flow
We enrolled patients participants at the Jikei University Hospital.
Written informed consent was obtained from each subject.
Adverse events
None
Outcome measures
Salivary human herpesvirus (HHV-) 6 DNA quantities, Salivary HHV-7 DNA quantities and apnea-hypopnea index (AHI).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2013 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2013 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study was approved again by the Ethics Committees of the Jikei University School of Medicine on 14 November 2017.
Management information
Registered date
| 2013 | Year | 10 | Month | 21 | Day |
Last modified on
| 2019 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014130
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| Registered date | File name |
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