UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051078 |
|---|---|
| Receipt number | R000058240 |
| Scientific Title | Nocturia improves with personalized bedtime; A prospective interventional crossover study. |
| Date of disclosure of the study information | 2023/05/17 |
| Last modified on | 2023/11/16 16:38:59 |
* 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
Optimal bedtime improve nocturia
Acronym
Optimal bedtime improve nocturia
Scientific Title
Nocturia improves with personalized bedtime; A prospective interventional crossover study.
Scientific Title:Acronym
Construction of personalized bedtime program to improve nocturia; a crossover study
Region
| Japan |
Condition
Condition
Nocturia
Classification by specialty
| Psychiatry | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examined whether nocturia could be improved by adhering to an appropriate bedtime.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in nocturnal urinary frequency
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Using a wearable device to measure bedtime and mid wake time for one week, the bedtime with the shortest mid wake time was set using the steepest descent method, and the participants were asked to go to bed at that time for three weeks. After two weeks washout period, the participants sleep for four weeks with usual bedtime.
Interventions/Control_2
participants sleep for four weeks with usual bedtime at first, after two weeks wash out period, they use a wearable device to measure bedtime and mid wake time for one week, the bedtime with the shortest mid wake time was set using the steepest descent method, and the participants were asked to go to bed at that time for three weeks.
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
| 65 | years-old | <= |
Age-upper limit
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with one or more complaints of nocturia that do not improve with medication or other behavioral therapies.
Key exclusion criteria
Those who have difficulty going to the hospital or who have such severe cognitive decline that they are unable to use the machines.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Yoshinaga |
| Middle name | |
| Last name | Okumura |
Organization
University of Fukui
Division name
Urology
Zip code
9101193
Address
23-3, Matsuoka shimoaizuki, Eiheiji-cho, Yoshiga-gun, Fukui
TEL
0776618174
urokumura@gmail.com
Public contact
Name of contact person
| 1st name | Yoshinaga |
| Middle name | |
| Last name | Okumura |
Organization
University of Fukui
Division name
Department of urology
Zip code
9101193
Address
23-3, Matsuoka shimoaizuki, Eiheiji-cho, Yoshiga-gun, Fukui
TEL
0776613111
Homepage URL
urokumura@gmail.com
Sponsor or person
Institute
University of Fukui
Institute
Department
Personal name
Funding Source
Organization
Japan Geriatric Urology Association.
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
The Research Ethics Committee of University of Fukui
Address
23-3, Matsuoka shimoaizuki, Eiheiji-cho, Yoshiga-gun, Fukui
Tel
0776618614
rinsho-rinri@ml.u-fukui.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 | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 03 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 06 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 17 | Day |
Last modified on
| 2023 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058240
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
