UMIN-CTR Clinical Trial

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
Email	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
Email	tsuyoshi@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046268