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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | Thyrotoxicosis | ||
Classification by specialty |
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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 | |
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Interventions/Control_7 | |
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Interventions/Control_9 | |
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 90 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
k-matsumoto@tottori-u.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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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 |
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Last modified on |
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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 |