UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036113 |
|---|---|
| Receipt number | R000032462 |
| Scientific Title | The relationship between thyrotoxicosis and sleep disorder |
| Date of disclosure of the study information | 2019/03/07 |
| Last modified on | 2023/04/04 16:58:47 |
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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-equivalence
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 | Shoichiro |
| Middle name | |
| Last name | Izawa |
Organization
Tottori university Hospital
Division name
Division of Molecular Medicine and Therapeutics
Zip code
683-8504
Address
36-1, Nishi, Yonago-shi, Tottori,Japan
TEL
0859-38-6517
kazu.matsumoto@tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhisa |
| Middle name | |
| Last name | Matsumoto |
Organization
Tottori university Hospital
Division name
Division of Molecular Medicine and Therapeutics
Zip code
683-8504
Address
36-1, Nishi, Yonago-shi, Tottori,Japan
TEL
0859-38-6517
Homepage URL
kazu.matsumoto@tottori-u.ac.jp
Sponsor or person
Institute
Tottori university Hospital
Institute
Department
Personal name
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
Tottori university Hospital
Address
36-1, Nishi, Yonago-shi, Tottori,Japan
Tel
0859-38-6517
kazu.matsumoto@tottori-u.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
76
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
| 2017 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2019 | Year | 03 | Month | 06 | Day |
Last modified on
| 2023 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032462
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
