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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036113
Receipt No. R000032462
Scientific Title The relationship between thyrotoxicosis and sleep disorder
Date of disclosure of the study information 2019/03/07
Last modified on 2019/03/07

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Basic information
Public title The relationship between thyrotoxicosis and sleep disorder
Acronym between thyroid hormone and sleep disorder
Scientific Title The relationship between thyrotoxicosis and sleep disorder
Scientific Title:Acronym between thyroid hormone and sleep disorder
Region
Japan

Condition
Condition Thyrotoxicosis
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate the relationship between thyroid function and disease activity and sleep disorder in patients with thyrotoxicosis
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change rate of total score of Pittsburgh Sleep Questionnaire (PSQI) before and 12,26 and 52 weeks after treatment in patients with thyrotoxicosis
Key secondary outcomes Sleep quality, sleeping time, sleeping time, sleep efficiency, difficulty sleeping, use of sleeping agents, difficulty during daytime awakening, change rate of SF - 36

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

Not applicable
Gender Male and Female
Key inclusion criteria 1.Uncontrolled Grave's disease
Male and female aged 20 years or older at the time of consent acquisition
Those who have been diagnosed as Graves' disease, subacute thyroiditis, or painless thyroiditis according to guidelines from the Japanese Thyroid Association

2.euthyroid patients
Men and women aged 20 years or older at the time of consent acquisition
Those with TSH and Free T4 within the reference range by treatment of Graves' disease, indolent thyroiditis, subacute thyroiditis


3. Normal control
Men and women aged 20 years or older at the time of consent acquisition
Those who have no history of thyroid disease
TSH and Free T4 are within the reference range
TRAb negative person
Key exclusion criteria Patient diagnosed as sleep apnea with simple PSG
Pregnant or lactating women
Patients with respiratory disease
Patients with heart disease
Patients with cerebrovascular disease, dementia
Patients with mental illness
Others who judged that the research director is inappropriate as a patient
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shoichiro Izawa
Organization Tottori university Hospital
Division name Division of Molecular Medicine and Therapeutics
Zip code
Address 36-1, Nishi, Yonago-shi, Tottori,Japan
TEL 0859-38-6517
Email k-matsumoto@tottori-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhisa Matsumoto
Organization Tottori university Hospital
Division name Division of Molecular Medicine and Therapeutics
Zip code
Address 36-1, Nishi, Yonago-shi, Tottori,Japan
TEL 0859-38-6517
Homepage URL
Email k-matsumoto@tottori-u.ac.jp

Sponsor
Institute Tottori university Hospital
Institute
Department

Funding Source
Organization Tottori university Hospital
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
Email

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
2019 Year 03 Month 07 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 Enrolling by invitation
Date of protocol fixation
2017 Year 08 Month 25 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Unpublished

Management information
Registered date
2019 Year 03 Month 06 Day
Last modified on
2019 Year 03 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032462

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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