UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000041541 |
|---|---|
| Receipt number | R000046664 |
| Scientific Title | The effects of a subjective sleep improvement program on convalescent stroke patients with insomnia during hospitalization: a randomized controlled trial |
| Date of disclosure of the study information | 2022/09/30 |
| Last modified on | 2024/04/10 11:16:03 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The effects of a subjective sleep improvement program on convalescent stroke patients with insomnia during hospitalization: a randomized controlled trial
Acronym
The effects of a subjective sleep improvement program on convalescent stroke patients with insomnia during hospitalization: a randomized controlled trial
Scientific Title
The effects of a subjective sleep improvement program on convalescent stroke patients with insomnia during hospitalization: a randomized controlled trial
Scientific Title:Acronym
The effects of a subjective sleep improvement program on convalescent stroke patients with insomnia during hospitalization: a randomized controlled trial
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Neurology | Neurosurgery | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of the subjective sleep feeling improvement program for convalescent stroke patients with insomnia who are admitted to convalescent rehabilitation hospital.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The MA version of the OSA Sleep Questionnaire calculates the average pre- and post-program 7-day scores for the five subscales, and the amount of pre- and post-program change for each subscale
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
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Two weeks subjective sleep improvement program
sleep hygiene education and relaxation
Interventions/Control_2
Receive normal care as usual
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
| 50 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The diagnosis is cerebral infarction or cerebral hemorrhage
One month has passed since the stroke
Key exclusion criteria
Those who have serious complications or physical symptoms that cannot implement the program contents
Sleep disorders other than insomnia
Those who have no sleep above the cutoff value using the Athens Insomnia Scale
Those who take regular sleeping pills
Person with dementia
Those with a diagnosis of depression or mental illness
Persons with physical disorders accompanied by sleep disorders
Stroke patients undergoing medical treatment in a private room
Target sample size
82
Research contact person
Name of lead principal investigator
| 1st name | yoshiaki |
| Middle name | |
| Last name | Y-y-4419 |
Organization
Toyohashi Sozo University
Division name
Department of Nursing, Faculty of Health Sciences
Zip code
4408511
Address
20-1 Matsushita Ushikawacho, Toyohashi-shi, Aichi-ken
TEL
0532542111
y-yamamoto@sozo.ac.jp
Public contact
Name of contact person
| 1st name | yoshiaki |
| Middle name | |
| Last name | Y-y-4419 |
Organization
Toyohashi Sozo University
Division name
Department of Nursing, Faculty of Health Sciences
Zip code
4408511
Address
20-1 Matsushita Ushikawacho, Toyohashi-shi, Aichi-ken
TEL
0532542111
Homepage URL
y-yamamoto@sozo.ac.jp
Sponsor or person
Institute
Toyohashi Sozo University
Institute
Department
Personal name
Funding Source
Organization
Absent
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 Ushikawacho, Toyohashi-shi, Aichi-ken
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
| 2022 | Year | 09 | Month | 30 | Day |
Related information
URL releasing protocol
2023/3/31
Publication of results
Published
Result
URL related to results and publications
2023/3/31
Number of participants that the trial has enrolled
82
Results
Following the intervention, the OSA-MA sleep inventory score was significantly higher in the intervention group than in the control group for factor 1, sleepiness on rising (p = .010), factor 4, refreshing (p = .004) and factor 5, sleep length (p = .001).
Results date posted
| 2024 | Year | 04 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The age of the participants was 67.4 years, and 35 (42.7%) were female. The time from stroke onset to enrolment was 39.5 days, 56 patients had cerebral infarction, and 26 had cerebral hemorrhage. The FIM was 78.9. There were 37 (45.1%) participants whose sleep status before stroke onset included insomnia symptoms, and the Athens Insomnia Scale score was 9.2. A comparison of basic attributes and the OSA-MA sleep inventory between the intervention and control groups prior to implementing the program showed no significant differences in any items.
Participant flow
From the study site, 137 patients were referred, of which 108 did not meet any exclusion criteria and consented to participate in the study. These patients were screened for insomnia, and 82 were enrolled. These 82 participants were randomized to an intervention group and a control group, with 41 in each group. Of these, 37 intervention group participants and 38 control group participants completed the program, and 4 intervention group participants and 3 control group participants dropped out (drop-out rate 8.5%).
Adverse events
NONE
Outcome measures
For the OSA-MA sleep inventory, the mean scores of the five subscales for the seven days before and after the program were calculated, and the amount of change in each subscale after the program was analyzed using a t-test, with a significance level of 5%.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 08 | Month | 13 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 09 | Month | 15 | Day |
Date trial data considered complete
| 2022 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 25 | Day |
Last modified on
| 2024 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046664
| Research Plan | |
|---|---|
| Registered date | File name |
| 2024/04/08 | Title Page.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2024/04/08 | Main Document.pdf |
