UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040532 |
|---|---|
| Receipt number | R000046268 |
| Scientific Title | A study of sleep-wake determination accuracy by actigraphic measurement with automatic algorithms compared to polysomnography |
| Date of disclosure of the study information | 2020/05/27 |
| Last modified on | 2021/03/23 11:10:29 |
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Basic information
Public title
A study of sleep-wake determination accuracy by actigraphic measurement with automatic algorithms compared to polysomnography
Acronym
A study of sleep-wake determination accuracy by actigraphic measurement with automatic algorithms compared to polysomnography
Scientific Title
A study of sleep-wake determination accuracy by actigraphic measurement with automatic algorithms compared to polysomnography
Scientific Title:Acronym
A study of sleep-wake determination accuracy by actigraphic measurement with automatic algorithms compared to polysomnography
Region
| Japan |
Condition
Condition
Sleep disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
An examination of sleep-wake determination accuracy by actigraphy with automatic algorithms
Basic objectives2
Others
Basic objectives -Others
Validity
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Consistency and correlation of sleep onset, sleep offset, and sleep time between polysomnography and automatic actigraphic determination
Key secondary outcomes
Consistency of sleep-wake by epoch between polysomnography and automatic actigraphic determination
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients visiting sleep clinic in Fujita Health University Hospital, department of psychiatry, who undergo polysomnography in sleep-lab in Fujita Health University Hospital for examination of their sleep disorders
Patients who have received sufficient explanation and who have given their written consent based on their own free will
Patients aged 20 to under 75
Key exclusion criteria
Patients who are examined for abnormal nighttime behaviors
Other patients who are judged inappropriate by the researcher or research director
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Nakao |
| Middle name | |
| Last name | Iwata |
Organization
Fujita Health University School of Medicine
Division name
Department of Psychiatry
Zip code
470-1192
Address
1-98 Dengakugakubo,Kutsukakecho,Toyoake,Aichi,Japan
TEL
0562-93-2170
nakao@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Kitajima |
Organization
Fujita Health University School of Medicine
Division name
Department of Psychiatry
Zip code
470-1192
Address
1-98 Dengakugakubo,Kutsukakecho,Toyoake,Aichi,Japan
TEL
0562-93-2170
Homepage URL
tsuyoshi@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
The ethics committee of Fujita Health University
Address
1-98 Dengakugakubo,Kutsukakecho,Toyoake,Aichi,Japan
Tel
0562-93-2865
f-irb@fujita-hu.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
| 2020 | Year | 05 | Month | 27 | 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
22
Results
The accordance as to the sleep/wake judgment per epoch was 87.4% between the newly developed algorithm and PSG, which was equal to previous reports. There were no systematic and significant differences as to the sleep onset, sleep offset, and total sleep time between either two algorithm and PSG. There was significant difference as to the wake after sleep onset with shorter estimation by actigraphic two algorithms, and the total sleep time with longer estimation by them, comparing to PSG.
Results date posted
| 2021 | Year | 03 | Month | 23 | Day |
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
| 2020 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 27 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, existing actigraph will be used, and sleep-wake will be analyzed by both of existing and newly developed algorithms.
Management information
Registered date
| 2020 | Year | 05 | Month | 26 | Day |
Last modified on
| 2021 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046268
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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