UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045009 |
|---|---|
| Receipt number | R000051417 |
| Scientific Title | A study examining the relationship between sleep and vaccine acquired COVID-19 antibody titer |
| Date of disclosure of the study information | 2021/07/30 |
| Last modified on | 2024/04/23 12:16:56 |
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Basic information
Public title
A study examining the relationship between sleep and vaccine acquired COVID-19 antibody titer
Acronym
A study of sleep and COVID-19 antibody titer
Scientific Title
A study examining the relationship between sleep and vaccine acquired COVID-19 antibody titer
Scientific Title:Acronym
A study of sleep and COVID-19 antibody titer
Region
| Japan |
Condition
Condition
COVID-19, insomnia, shortage of sleep
Classification by specialty
| Infectious disease | Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is aim to develop sleep recommendation guidelines for COVID-19 vaccination by examining the relationship between subjective and objective sleep indices and antibody titers.
Basic objectives2
Others
Basic objectives -Others
The relationship between sleep and IgG antibody titer against COVID-19 spike protein and nucleotide protein after vaccination
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The relationship between objective and subjective sleep parameter and IgG antibody titer against COVID-19 spike protein and nucleotide protein two weeks after vaccination
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adults less than 60 years of age at the start of observation scheduled for COVID-19 vaccination.
Key exclusion criteria
1) Patients who cannot meet the selection criteria
2) Patients deemed inappropriate by the principal investigator
3) Patients who are abusing drugs at the start of observation
4) Patients suffering from a disease requiring drug therapy at the time of starting observation.
5) Vaccinated within one month of the start of the study
6) Has a clear history of COVID-19 (as evidenced by PCR test, etc.)
7) Satisfies the exclusion criteria for vaccination (previous allergy to vaccine, history of convulsions, possible allergy)
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Matsui |
| Middle name | |
| Last name | Kentaro |
Organization
National Institute of Mental Health, National Center of Neurology and Psychiatry
Division name
Department of Clinical Laboratory
Zip code
187-8551
Address
Ogawa higashi cho 4-1-1, Tokyo, Japan
TEL
042-341-2711
sdc.covid19.2021@gmail.com
Public contact
Name of contact person
| 1st name | Izuhara |
| Middle name | |
| Last name | Muneto |
Organization
National Institute of Mental Health, National Center of Neurology and Psychiatry
Division name
Department of Clinical Laboratory
Zip code
187-8551
Address
Ogawa higashi cho 4-1-1, Tokyo, Japan
TEL
042-341-2711
Homepage URL
sdc.covid19.2021@gmail.com
Sponsor or person
Institute
National Institute of Mental Health, National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
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
Ethics board of National Institute of Mental Health, National Center of Neurology and Psychiatry
Address
Ogawa higashi cho 4-1-1, Tokyo, Japan
Tel
0423412711
rinri-jimu@ncnp.go.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 30 | 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
50
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
| 2021 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Factors to be examined for association: To examine the association between IgG antibody titer against spike protein and nucleotide protein and objective and subjective sleep parameter 2 weeks after completion of vaccination
1) Background of the study subjects
Age, sex, region of birth and upbringing, current residence, number of compatriots, blood type, comorbidities, medical history, use of drugs and supplements, smoking, alcohol, exercise habits, height, weight, BMI, employment status, schooling status (education), income
2) Questionnaire
ESS, ISI, PSQI, DBAS, RBDSQ, IRLS, MCTQ, Stop-BANG, PHQ-9, PHQ15, GAD-7
Vaccine Adverse Reaction Health Observation Form
3) Blood collection items
COVID-19 spike-nucleotide IgG antibody titer
White blood cell count, CRP
4) Sleep parameter
Sleep diary and actigraph throughout the vaccination period
Management information
Registered date
| 2021 | Year | 07 | Month | 29 | Day |
Last modified on
| 2024 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051417
