UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049739 |
|---|---|
| Receipt number | R000056340 |
| Scientific Title | Relationship between sleep assessment index using sleep electroencephalogram and functional outcome in patients with cerebral infarction in the recovery phase |
| Date of disclosure of the study information | 2022/12/15 |
| Last modified on | 2023/04/20 13:02:46 |
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Basic information
Public title
Is Sleep Quality as Observed by Sleep Electroencephalography Related to Functional Recovery in Patients with Stroke?
Acronym
Sleep Quality and Functional Recovery in cerebral infarction patients
Scientific Title
Relationship between sleep assessment index using sleep electroencephalogram and functional outcome in patients with cerebral infarction in the recovery phase
Scientific Title:Acronym
Relationship between sleep and functional outcome in cerebral infarction patients
Region
| Japan |
Condition
Condition
cerebral infarction
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarify the relationship between sleep variables and functional outcomes in cerebral infarction patients admitted to a convalescent ward using an ADL assessment index that excludes sleep variables and ceiling effects from sleep EEG measurements.
Basic objectives2
Others
Basic objectives -Others
Clarify the relationship between FIM and sleep variables
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Partial correlation between Arousal Index and Functional Independence Measure (FIM) effectiveness, excluding the effect of age and depression using Hospital Anxiety and Depression Scale (HADS)
Key secondary outcomes
A) Correlation between the following items and FIM effectiveness
i) Sleep variables:
Sleep latency, total sleep time, sleep efficiency, Wake-time After Sleep Onset (WASO), arousal index, duration and incidence of each sleep stage, REM latency
ii) Subjective Sleep Quality:
Japanese version of the Pittsburgh Sleep Quality Index (PSQI) [Doi et al., 2000].
iii) Anxiety and depressive symptoms:
Japanese version of Hospital Anxiety and Depression Scale (HADS) [Hatta et al., 1998].
iv) Motor function:
Japanese version of the Fugl-Meyer assessment (FMA) [Amano et al, 2018; Nakazono et al, 2020].
v) Cognitive function:
japanese version of the Mini Mental State Examination (MMSE-J) [Sugishita, 2006], Japanese version of Raven's Colored Progressive Materices (RCPM) [Sugishita, 1993].
B) Correlations among the above items
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) First ischemic stroke
2) 18 years of age or older
Key exclusion criteria
1) Those with cerebellum lesion
2) Those with other neuropsychiatric disorders
3) Those with a history of sleep disorders prior to the onset of ischemic stroke
4) Those with dementia or aphasia to the extent that they are unable to answer the questionnaire
5) Those with new functional impairment due to complications during hospitalization.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Kyohei |
| Middle name | |
| Last name | Matsuda |
Organization
Faculty of Medicine, Kyorin University
Division name
Department of Rehabilitation Medicine
Zip code
1810004
Address
6-20-2, Shinkawa, Mitaka, Tokyo
TEL
0422-47-5511
k.matsuda@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Kyohei |
| Middle name | |
| Last name | Matsuda |
Organization
Faculty of Medicine, Kyorin University
Division name
Department of Rehabilitation Medicine
Zip code
1810004
Address
6-20-2, Shinkawa, Mitaka, Tokyo
TEL
0422-47-5511
Homepage URL
k.matsuda@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Tokyo angel hospital
Institute
Department
Personal name
Funding Source
Organization
Kyorin University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo angel hospital
Address
50-1, Kami-ichibukata-machi, Hachioji, Tokyo
Tel
042-651-5331
k.matsuda@ks.kyorin-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
| 2022 | Year | 12 | Month | 15 | 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
| 2022 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2022 | Year | 12 | Month | 09 | Day |
Last modified on
| 2023 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056340
