UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052170 |
|---|---|
| Receipt number | R000059538 |
| Scientific Title | The Role of Sleep in Functional Recovery in Stroke Patients. |
| Date of disclosure of the study information | 2023/09/11 |
| Last modified on | 2024/09/18 10:59:49 |
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Basic information
Public title
The Role of Sleep in Functional Recovery in Stroke Patients.
Acronym
Sleep in stroke patients.
Scientific Title
The Role of Sleep in Functional Recovery in Stroke Patients.
Scientific Title:Acronym
The Role of Sleep in Functional Recovery in Stroke Patients.
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aims of this study were to examine the role of sleep for skill learning, the condition of nighttime sleep, and the effects of sleep on rehabilitation training in stroke patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Motor skill tasks, and upper extremity performance on the paralyzed side
Key secondary outcomes
Polysomnography data.
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
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Stroke patients
Hemiplegic patients with unilateral cerebral lesions
Healthy person
1. Healthy, no current medical conditions, and not taking any medication
2. No history of stroke or other neurological diseases
Key exclusion criteria
1. Those who are unable to understand the purpose of the study owing to serious aphasia, higher brain dysfunction, or cognitive dysfunction.
2. Those who are unable to obtain written consent.
3. Those who have a diagnosis or history of psychiatric disorders.
4. Those who have a history of epileptic seizures, cardiac pacemakers, artificial heart valves, heart disease, or skin diseases.
5. Those who are habitual smokers.
6. Those who are engaged in the night shift.
7. Those who have color blindness.
8. Those who have less than 0.8 of visual acuity (including corrected vision) in both eyes.
9. Those who have a habit of playing action video games or computer games.
10. Those who have a diagnosis or history of sleep disorders or sleep apnea syndrome.
11. Those who have any kind of trouble sleeping.
12. Those who take medications involved in sleep or cognition.
13. Those who do not have a regular sleep-wake routine.
14. Those who have a habit of taking naps.
15. Those who have skin sensitivity to alcohol.
16. those who cannot wear EEG caps/electrodes.
17. Contraindications to exercise therapy as follows:
(i) Serious cardiac disease: unstable angina, myocardial infarction of short duration from onset, non-compensated congestive heart failure, acute pulmonary heart, poorly controlled arrhythmia, severe aortic stenosis, active myocarditis, and endocarditis
(ii) Uncontrolled hypertension
(iii) Acute systemic illness or fever
(iv) Recent pulmonary embolism, acute pulmonary heart, severe pulmonary hypertension
(v) Complications of serious hepatic or renal dysfunction
(vi) Complication of serious orthopedic disease that interferes with movement
(vii) Complication of severe cognitive impairment or severe psychiatric disease
(viii) Other metabolic disorders
18. those who are currently pregnant.
19. those who are currently participating in other experiments.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Michiyuki |
| Middle name | |
| Last name | Kawakami |
Organization
Keio University
Division name
Department of Rehabilitation Medicine
Zip code
160-8582
Address
35 Shinanomachi, Sinjuku-ku, Tokyo
TEL
03-5843-6169
michiyukikawakami@hotmail.com
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Ito |
Organization
Keio University
Division name
Department of Rehabilitation Medicine
Zip code
160-8582
Address
35 Shinanomachi, Sinjuku-ku, Tokyo
TEL
03-5843-6169
Homepage URL
taisho8036@gmail.com
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
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
RIKEN
Name of secondary funder(s)
The Uehara Memorial Foundation.
IRB Contact (For public release)
Organization
Keio University
Address
35 Shinanomachi, Sinjuku-ku, Tokyo
Tel
03-5843-6169
med-rinri-jimu@adst.keio.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
| 2023 | Year | 09 | Month | 11 | 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
3
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
| 2023 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Stroke patients undergo a total of 4 PSG before and after hospitalization, and nighttime sleep investigations on a simple electroencephalograph during hospitalization.
Healthy subjects undergo a total of 4 PSG.
Management information
Registered date
| 2023 | Year | 09 | Month | 11 | Day |
Last modified on
| 2024 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059538
