UMIN-CTR Clinical Trial

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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