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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000012093
Receipt No. 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

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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
Email 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
Email kobayashi-n@jikei.ac.jp

Sponsor
Institute The Jikei University School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014130

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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