UMIN-CTR 臨床試験登録情報の閲覧

一般向け試験名/Public title

日本語
住民健診における夜間頻尿と睡眠要害の縦断研究

英語
A longitudinal study for bidirectional relationships between sleep disorder and frequency of nocturia: Results from the Iwaki Health Promotion Project

一般向け試験名略称/Acronym

日本語
住民健診における夜間頻尿と睡眠要害の縦断研究

英語
A longitudinal study for bidirectional relationships between sleep disorder and frequency of nocturia: Results from the Iwaki Health Promotion Project

科学的試験名/Scientific Title

日本語
住民健診データベースを用い夜間頻尿と睡眠要害の相互作用を検討する縦断観察研究

英語
A longitudinal study for bidirectional relationships between sleep disorder and frequency of nocturia: Results from the Iwaki Health Promotion Project

科学的試験名略称/Scientific Title:Acronym

日本語
住民健診における夜間頻尿と睡眠要害の縦断研究

英語
A longitudinal study for bidirectional relationships between sleep disorder and frequency of nocturia: Results from the Iwaki Health Promotion Project

試験実施地域/Region

日本/Japan

対象疾患名/Condition

日本語
夜間頻尿と睡眠障害

英語
sleep disorder and frequency of nocturia

疾患区分1/Classification by specialty

泌尿器科学/Urology

疾患区分2/Classification by malignancy

悪性腫瘍以外/Others

ゲノム情報の取扱い/Genomic information

いいえ/NO

目的1/Narrative objectives1

日本語
夜間頻尿が睡眠障害に与える影響を検討する

英語
To investigated the natural course of sleep disorder and frequency of nocturia and causal relationship between them using longitudinal data in community-dwelling adults.

目的2/Basic objectives2

有効性/Efficacy

目的2 -その他詳細/Basic objectives -Others

日本語

英語

試験の性質1/Trial characteristics_1

試験の性質2/Trial characteristics_2

試験のフェーズ/Developmental phase

主要アウトカム評価項目/Primary outcomes

日本語
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.

英語
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.

副次アウトカム評価項目/Key secondary outcomes

日本語
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.

英語
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.

試験の種類/Study type

観察/Observational

基本デザイン/Basic design

ランダム化/Randomization

ランダム化の単位/Randomization unit

ブラインド化/Blinding

コントロール/Control

層別化/Stratification

動的割付/Dynamic allocation

試験実施施設の考慮/Institution consideration

ブロック化/Blocking

割付コードを知る方法/Concealment

群数/No. of arms

介入の目的/Purpose of intervention

介入の種類/Type of intervention

介入1/Interventions/Control_1

日本語

英語

介入2/Interventions/Control_2

日本語

英語

介入3/Interventions/Control_3

日本語

英語

介入4/Interventions/Control_4

日本語

英語

介入5/Interventions/Control_5

日本語

英語

介入6/Interventions/Control_6

日本語

英語

介入7/Interventions/Control_7

日本語

英語

介入8/Interventions/Control_8

日本語

英語

介入9/Interventions/Control_9

日本語

英語

介入10/Interventions/Control_10

日本語

英語

年齢（下限）/Age-lower limit

20

歳/years-old

以上/<=

年齢（上限）/Age-upper limit

100

歳/years-old

未満/>

性別/Gender

男女両方/Male and Female

選択基準/Key inclusion criteria

日本語
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.

英語
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.

除外基準/Key exclusion criteria

日本語
Exclusion criteria were insufficient report of questionnaire for comorbidity, PSQI, and IPSS.

英語
Exclusion criteria were insufficient report of questionnaire for comorbidity, PSQI, and IPSS.

目標参加者数/Target sample size

600

責任研究者/Name of lead principal investigator

日本語

名	真吾
ミドルネーム
姓	畠山

英語

名	Shingo
ミドルネーム	Hatakeyama
姓	Hatakeyama

所属組織/Organization

日本語
弘前大学医学部

英語
Dept. of Urology, Hirosaki University Graduate School of Medicin

所属部署/Division name

日本語
Urology

英語
Urology

郵便番号/Zip code

036-8562

住所/Address

日本語
5 Zaifu-chou, Hirosaki

英語
5 Zaifu-chou, Hirosaki

電話/TEL

0172395091

Email/Email

shingoh@hirosaki-u.ac.jp

試験問い合わせ窓口担当者/Name of contact person

日本語

名	真吾
ミドルネーム
姓	畠山

英語

名	Shingo
ミドルネーム
姓	Hatakeyama

組織名/Organization

日本語
Dept. of Urology, Hirosaki University Graduate School of Medicine

英語
Dept. of Urology, Hirosaki University Graduate School of Medicine

部署名/Division name

日本語
Urology

英語
Urology

郵便番号/Zip code

036-8562

住所/Address

日本語
5 Zaifu-chou

英語
Hirosaki

電話/TEL

0172395091

試験のホームページURL/Homepage URL

Email/Email

shingoh@hirosaki-u.ac.jp

機関名/Institute

日本語
弘前大学

英語
Dept. of Urology, Hirosaki University Graduate School of Medicine

機関名/Institute
（機関選択不可の場合）

日本語
Dept. of Urology, Hirosaki University Graduate School of Medicine

部署名/Department

日本語

個人名/Personal name

日本語

英語

機関名/Organization

日本語
弘前大学

英語
Dept. of Urology, Hirosaki University Graduate School of Medicine

機関名/Organization
（機関選択不可の場合）

日本語
Dept. of Urology, Hirosaki University Graduate School of Medicine

組織名/Division

日本語

組織の区分/Category of Funding Organization

その他/Other

研究費拠出国/Nationality of Funding Organization

日本語
日本

英語

共同実施組織/Co-sponsor

日本語

英語

その他の研究費提供組織/Name of secondary funder(s)

日本語

英語

組織名/Organization

日本語
Hirosaki University Graduate School of Medicine

英語
Hirosaki University Graduate School of Medicine

住所/Address

日本語
5 Zaifu-chou, Hirosaki

英語
5 Zaifu-chou, Hirosaki

電話/Tel

+81172395091

Email/Email

rinri@hirosaki-u.ac.jp

他機関から発行された試験ID/Secondary IDs

いいえ/NO

試験ID1/Study ID_1

ID発行機関1/Org. issuing International ID_1

日本語

英語

試験ID2/Study ID_2

ID発行機関2/Org. issuing International ID_2

日本語

英語

治験届/IND to MHLW

試験実施施設名称/Institutions

弘前大学附属病院

一般公開日（本登録希望日）/Date of disclosure of the study information

2020

年

03

月

10

日

プロトコル掲載URL/URL releasing protocol

https://pubmed.ncbi.nlm.nih.gov/32496639/

試験結果の公開状況/Publication of results

最終結果が公表されている/Published

結果掲載URL/URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/32496639/

組み入れ参加者数/Number of participants that the trial has enrolled

723

主な結果/Results

日本語
The effect of OAB symptoms and sleep disturbance on indoor fall events was significant. The causal relationship between OAB and falls needs further study.

英語
The effect of OAB symptoms and sleep disturbance on indoor fall events was significant. The causal relationship between OAB and falls needs further study.

主な結果入力日/Results date posted

2022

年

12

月

06

日

結果掲載遅延/Results Delayed

結果遅延理由/Results Delay Reason

日本語

英語

最初の試験結果の出版日/Date of the first journal publication of results

参加者背景/Baseline Characteristics

日本語
To evaluate the effect of overactive bladder (OAB) and frailty on indoor fall events in community-dwelling adults aged 50 or older.

英語
To evaluate the effect of overactive bladder (OAB) and frailty on indoor fall events in community-dwelling adults aged 50 or older.

参加者の流れ/Participant flow

日本語
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.

英語
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.

有害事象/Adverse events

日本語
none

英語
none

評価項目/Outcome measures

日本語
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.

英語
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.

個別症例データ共有計画/Plan to share IPD

日本語

英語

個別症例データ共有計画の詳細/IPD sharing Plan description

日本語

英語

試験進捗状況/Recruitment status

試験終了/Completed

プロトコル確定日/Date of protocol fixation

2009

年

05

月

01

日

倫理委員会による承認日/Date of IRB

2018

年

08

月

24

日

登録・組入れ開始（予定）日/Anticipated trial start date

2009

年

05

月

01

日

フォロー終了(予定)日/Last follow-up date

2022

年

12

月

31

日

入力終了(予定)日/Date of closure to data entry

データ固定（予定）日/Date trial data considered complete

解析終了(予定)日/Date analysis concluded

その他関連情報/Other related information

日本語
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.

英語
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.

登録日時/Registered date

2020

年

03

月

09

日

最終更新日/Last modified on

2022

年

12

月

06

日

閲覧ページへのリンク/Link to view the page

日本語
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000045329

英語
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045329