UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053635 |
|---|---|
| Receipt number | R000061214 |
| Scientific Title | Objective effects of a program to improve insomnia in hospitalized stroke patients: a pilot RCT |
| Date of disclosure of the study information | 2024/02/17 |
| Last modified on | 2025/02/17 09:09:12 |
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Basic information
Public title
Objective effects of a program to improve insomnia in hospitalized stroke patients: a pilot RCT
Acronym
Objective effects of a program to improve insomnia in hospitalized stroke patients: a pilot RCT
Scientific Title
Objective effects of a program to improve insomnia in hospitalized stroke patients: a pilot RCT
Scientific Title:Acronym
Objective effects of a program to improve insomnia in hospitalized stroke patients: a pilot RCT
Region
| Japan |
Condition
Condition
Stroke (cerebral infarction, cerebral hemorrhage)
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A program developed for hospitalized recovering stroke patients will be used to investigate the impact of the program on objective sleep assessment. The intervention group will receive the program for 14 days, and the control group will receive usual care. Sleep status (objective sleep assessment) for 7 days before and after the program will be investigated.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The amount of pre- and post-intervention change in the 7-day averages of objective sleep assessments: sleep latency, sleep efficiency, total sleep time, time of mid-wake, and number of mid-wake
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Undergo a 2-week program to improve insomnia (sleep hygiene education, relaxation methods)
Interventions/Control_2
Receive usual care (care provided in the hospital ward)
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Diagnosis name is cerebral infarction or cerebral hemorrhage
Those who have had a stroke within 1 month of onset of stroke
Persons with insomnia
Key exclusion criteria
Persons with severe complications or physical symptoms that prevent the program from being implemented
Persons with sleep disorders other than insomnia
Persons taking regular oral sleeping pills
Persons with dementia
Persons with a diagnosis of depression or mental illness
Those with physical illnesses (chronic obstructive pulmonary disease, bronchial asthma, heart failure, renal dialysis, rheumatic diseases, fibromyalgia, atopic dermatitis) that accompany sleep disorders
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yamamoto |
| Middle name | |
| Last name | Yoshiaki |
Organization
Toyohashi Sozo University
Division name
Department of Nursing, Faculty of Health Sciences
Zip code
4408511
Address
20-1 Matsushita, Ushikawa-cho, Toyohashi-shi, Aichi, Japan
TEL
0532549511
y-yamamoto@sozo.ac.jp
Public contact
Name of contact person
| 1st name | Yamamoto |
| Middle name | |
| Last name | Yoshiaki |
Organization
Toyohashi Sozo University
Division name
Department of Nursing, Faculty of Health Sciences
Zip code
4408511
Address
20-1 Matsushita, Ushikawa-cho, Toyohashi-shi, Aichi, Japan
TEL
0532549511
Homepage URL
y-yamamoto@sozo.ac.jp
Sponsor or person
Institute
Toyohashi Sozo University
Institute
Department
Personal name
Y-y-4419
Funding Source
Organization
Toyohashi Sozo 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
Toyohashi Sozo University
Address
20-1 Matsushita, Ushikawa-cho, Toyohashi-shi, Aichi, Japan
Tel
0532542111
y-yamamoto@sozo.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
| 2024 | Year | 02 | Month | 17 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 02 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 23 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 16 | Day |
Last modified on
| 2025 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061214
