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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039744
Receipt No. 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 2020/03/09

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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
Email 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
Email shingoh@hirosaki-u.ac.jp

Sponsor
Institute Dept. of Urology, Hirosaki University Graduate School of Medicine
Institute
Department

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
Email 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
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
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
2025 Year 03 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
2020 Year 03 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045329

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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