UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063459 |
|---|---|
| Receipt number | R000072504 |
| Scientific Title | Association between sleep fragmentation and improvement in activities of daily living in patients with spinal cord injury |
| Date of disclosure of the study information | 2026/10/29 |
| Last modified on | 2026/10/29 13:38:47 |
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Basic information
Public title
A study of how interrupted sleep affects recovery of daily activities in people with spinal cord injury
Acronym
Sleep and daily activity recovery after spinal cord injury
Scientific Title
Association between sleep fragmentation and improvement in activities of daily living in patients with spinal cord injury
Scientific Title:Acronym
Sleep fragmentation and ADL improvement in SCI
Region
| Japan |
Condition
Condition
Spinal cord injury
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To our knowledge, no study has quantitatively assessed sleep, which plays an important role in the consolidation of motor learning, using sleep electroencephalography (EEG) and examined its association with improvement in activities of daily living (ADL) in patients with spinal cord injury (SCI). This study aims to clarify the relationship between sleep variables and functional outcomes in patients with SCI admitted to a musculoskeletal disease ward, using sleep variables derived from sleep EEG and an ADL measure that accounts for ceiling effects.
Basic objectives2
Others
Basic objectives -Others
exploration of prognostic factors
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SCIM effectiveness, calculated as (SCIM score at discharge - SCIM score at admission) / (100 - SCIM score at admission).
Key secondary outcomes
A) Correlations between SCIM effectiveness and the following variables:
- Sleep variables: sleep latency, total sleep time, sleep efficiency, wake after sleep onset (WASO), arousal index (ArI), duration and percentage of each sleep stage, and REM latency
- Subjective sleep quality: Japanese version of the Pittsburgh Sleep Quality Index (PSQI) [Doi et al., 2000]
- Anxiety and depressive symptoms: Japanese version of the Hospital Anxiety and Depression Scale (HADS) [Hatta et al., 1998]
- Motor and sensory function: International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
B) Correlations among the above variables
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. Patients with a first-time spinal cord injury
2. Aged 18 years or older
3. American Spinal Injury Association Impairment Scale (AIS) grade A-D
4. Written informed consent to participate in the study
Key exclusion criteria
1. AIS grade E
2. Cauda equina syndrome, defined as a lesion confined to the conus medullaris or below with predominantly lower motor neuron 3. signs, based on a comprehensive assessment of imaging and neurological findings
4. History of central motor impairment, such as stroke
5. Apparent dementia
6. Diagnosed neurological other than spinal cord injury or psychiatric disorders
7. Serious complications during hospitalization resulting in new functional impairment
8. Spinal Cord Independence Measure III (SCIM III) score of 100 at admission
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kyohei |
| Middle name | |
| Last name | Matsuda |
Organization
National Hospital Organization Murayama Medical Center
Division name
Department of Clinical Research
Zip code
208-0011
Address
2-37-1 Gakuen, Musashimurayama-shi, Tokyo, Japan
TEL
042-561-1221
kmatsuda651522@gmail.com
Public contact
Name of contact person
| 1st name | Kyohei |
| Middle name | |
| Last name | Matsuda |
Organization
National Hospital Organization Murayama Medical Center
Division name
Department of Clinical Research
Zip code
208-0011
Address
2-37-1 Gakuen, Musashimurayama-shi, Tokyo, Japan
TEL
042-561-1221
Homepage URL
kmatsuda651522@gmail.com
Sponsor or person
Institute
National Hospital Organization Murayama Medical Center (Department of Clinical Research)
Institute
Department
Personal name
Kyohei MATSUDA
Funding Source
Organization
Japan Society for the Promotion of Science
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
Ethics Committee, National Hospital Organization Murayama Medical Center
Address
2-37-1 Gakuen, Musashimurayama-shi, Tokyo, Japan
Tel
042-561-1221
218-rinri@mail.hosp.go.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
| 2026 | Year | 10 | Month | 29 | 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
| 2026 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 29 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center prospective observational study. A total of 50 patients with spinal cord injury admitted to National Hospital Organization Murayama Medical Center will be enrolled. Sleep EEG will be recorded using a portable EEG device (InSomnograf) within 2 weeks after admission, and sleep variables will be calculated. The PSQI and HADS will be assessed during the same period. The SCIM III and ISNCSCI will be assessed at admission and discharge, and SCIM effectiveness will be calculated. The association between sleep variables and SCIM effectiveness will be examined using correlation and multivariable analyses. No intervention will be performed.
Management information
Registered date
| 2026 | Year | 10 | Month | 29 | Day |
Last modified on
| 2026 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072504
