UMIN-CTR Clinical Trial

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