UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000043713
Receipt No. R000049777
Scientific Title Examination of night excretion care aiming at improvement of the sleep / wake rhythm of elderly people entering long-term care insurance facilities
Date of disclosure of the study information 2021/05/01
Last modified on 2021/03/18

* 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 Study of night excretion aiming at improvement of the sleep-wake rhythm of the elderly
Acronym Study of night excretion aiming at improvement of the sleep-wake rhythm of the elderly
Scientific Title Examination of night excretion care aiming at improvement of the sleep / wake rhythm of elderly people entering long-term care insurance facilities
Scientific Title:Acronym Examination of night excretion care aiming at improvement of the sleep / wake rhythm of elderly people entering long-term care insurance facilities
Region
Japan

Condition
Condition Irregular sleep-wake rhythm disorder
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 the frequency of night-time diaper changes conducted at fixed times at nursing care insurance facility was reduced from per night and the resulting changes in sleep variables were considered along with the characteristics of the elderly residents, with the goal of acquiring hints for diaper-changing methods that could improve sleep quality.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Decrease in wake after sleep onset
Key secondary outcomes changes in sleep variables

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 the frequency of night-time diaper changes conducted at fixed times at a single nursing care insurance facility was reduced from twice to once per night and the resulting changes in sleep variables were considered along with the characteristics of the elderly residents,
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Consent to research
Entering a long-term care insurance facilities
Change diapers at night
Key exclusion criteria Skin disorders
Sleeping disorder
Urinary disorders
Posture change
Planning to leave the facility
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Madoka
Middle name
Last name Konishi
Organization St.Catherine University
Division name Department of Nursing
Zip code 790-0022
Address 1-10 Eidaicyo,Matuyama
TEL 0899470502
Email konishi@catherine.ac.jp

Public contact
Name of contact person
1st name Madoka
Middle name
Last name Konishi
Organization St.Catherine University
Division name Department of Nursing
Zip code 790-0022
Address 1-10 Eidaicyo,Matuyama
TEL 0899470502
Homepage URL
Email konishi@catherine.ac.jp

Sponsor
Institute Osaka City University
Institute
Department

Funding Source
Organization the Japan Society for the Promotion of Science
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 Osaka City University
Address 1-5-17 Asahi-machi, Abeno-ku, Osaka
Tel 0666453548
Email d16na001@yf.osaka-cu.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
2021 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 20
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 No longer recruiting
Date of protocol fixation
2017 Year 06 Month 01 Day
Date of IRB
2017 Year 12 Month 06 Day
Anticipated trial start date
2018 Year 04 Month 01 Day
Last follow-up date
2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 03 Month 23 Day
Last modified on
2021 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049777

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.