UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039744 |
|---|---|
| Receipt number | R000045329 |
| Scientific Title | A longitudinal study for bidirectional relationships between sleep disorder and frequency of nocturia: Results from the Iwaki Health Promotion Project |
| Date of disclosure of the study information | 2020/03/10 |
| Last modified on | 2022/12/06 12:30:38 |
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Basic information
Public title
A longitudinal study for bidirectional relationships between sleep disorder and frequency of nocturia: Results from the Iwaki Health Promotion Project
Acronym
A longitudinal study for bidirectional relationships between sleep disorder and frequency of nocturia: Results from the Iwaki Health Promotion Project
Scientific Title
A longitudinal study for bidirectional relationships between sleep disorder and frequency of nocturia: Results from the Iwaki Health Promotion Project
Scientific Title:Acronym
A longitudinal study for bidirectional relationships between sleep disorder and frequency of nocturia: Results from the Iwaki Health Promotion Project
Region
| Japan |
Condition
Condition
sleep disorder and frequency of nocturia
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigated the natural course of sleep disorder and frequency of nocturia and causal relationship between them using longitudinal data in community-dwelling adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcomes were the new-onset of sleep disorder (PSQI >5) or frequency of nocturia >1 and the changes of nocturia and PSQI for 5 years.
Key secondary outcomes
Secondary outcomes included the bidirectional relationships between sleep disorder and nocturia between the baseline and 5-year follow-up. A cross-lagged panel analysis was performed to analyze the bidirectional association between sleep disorder and nocturia.
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria for the primary and secondary outcomes were participants 1) with aged 50 or older, 2) who do not have sleep disorder (PSQI<=5), and 3) frequency of nocturia 0 or 1 time per night (nocturia<=1). Inclusion criteria for the exploratory outcomes was 1) participants who had baseline nocturia >1 or baseline PSQI >5 regardless of age.
Key exclusion criteria
Exclusion criteria were insufficient report of questionnaire for comorbidity, PSQI, and IPSS.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | Hatakeyama |
| Last name | Hatakeyama |
Organization
Dept. of Urology, Hirosaki University Graduate School of Medicin
Division name
Urology
Zip code
036-8562
Address
5 Zaifu-chou, Hirosaki
TEL
0172395091
shingoh@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Hatakeyama |
Organization
Dept. of Urology, Hirosaki University Graduate School of Medicine
Division name
Urology
Zip code
036-8562
Address
Hirosaki
TEL
0172395091
Homepage URL
shingoh@hirosaki-u.ac.jp
Sponsor or person
Institute
Dept. of Urology, Hirosaki University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Dept. of Urology, Hirosaki University Graduate School of Medicine
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
Hirosaki University Graduate School of Medicine
Address
5 Zaifu-chou, Hirosaki
Tel
+81172395091
rinri@hirosaki-u.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
弘前大学附属病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 10 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/32496639/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/32496639/
Number of participants that the trial has enrolled
723
Results
The effect of OAB symptoms and sleep disturbance on indoor fall events was significant. The causal relationship between OAB and falls needs further study.
Results date posted
| 2022 | Year | 12 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
To evaluate the effect of overactive bladder (OAB) and frailty on indoor fall events in community-dwelling adults aged 50 or older.
Participant flow
We conducted a cross-sectional study involving 723 adults between 2016 and 2017 in Hirosaki, Japan. OAB symptoms and sleep disturbance were assessed using the Overactive Bladder Symptom Score (OABSS) and the Pittsburgh Sleep Quality Index (PSQI). Indoor fall events (falls or near-falls) within 1 year were evaluated. Frailty was evaluated by the frailty discriminant score.
Adverse events
none
Outcome measures
We investigated the association of OAB symptoms with sleep disturbance, frailty, and indoor fall events. Multivariate logistic regression analysis was performed to investigate the effect of OAB symptoms on fall events controlling for confounding factors such as age, gender, comorbidity, frailty, and sleep disturbance.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2009 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2009 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Information on the disease history of cardiovascular disease (CVD) and type 2 diabetes mellitus (DM) was obtained via questionnaire. Diabetic patients were defined as those with a history of type 2 DM or those who met the relevant diagnostic criteria and required glycemic control. CVD was defined as a positive history of cardiac surgery, myocardial infarction, angina, stroke, or taking any cardiotonic agents. Sleep disorder and frequency of nocturia were measured using the Japanese version of the Pittsburgh Sleep Quality Index (PSQI) and the International Prostate Symptom Score (IPSS). The PSQI is a widely-used tool to measure the quality and pattern of sleep in older adults. The total scores provide an assessment of overall sleep quality (range from 0 to 21) and sleep disorder was defined as a PSQI >5.
Management information
Registered date
| 2020 | Year | 03 | Month | 09 | Day |
Last modified on
| 2022 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045329
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