UMIN-CTR Clinical Trial

Basic information
Public title	A study of the effects of regular health guidance and feedback of sleep reports to older people living in the community using a sleep measurement device
Acronym	Sakai Sleep ICT Study
Scientific Title	Effects of ICT-based sleep report feedback and regular health guidance on the older living alone or pre-frail or frail people in the community: a randomized controlled trial
Scientific Title:Acronym	RCT of ICT-based sleep report feedback and health guidance for community-dwelling older people
Region	Japan

Condition
Condition	normal older people
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effectiveness of an intervention using feedback from sleep reports and regular health guidance generated using a device that continuously measures the sleep of community-dwelling older people.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Athens insomnia scale
Key secondary outcomes	Interest in sleep: whether or not you are interested in sleep and how satisfied you are with your sleep (1-10) Degree of understanding of own sleep situation: 16 items about bedtime, waking time, dreaming, sleep talk, behavior during sleep, etc. Awareness of sleep habits: do you want to improve/maintain your sleep habits (very much, fairly much, not very much, not at all) Presence of sleep disturbances Change in exercise habits Change in eating habits Participation in social activities Subjective sense of health: 4 levels Basic checklist for daily life Loneliness: Japanese version of the UCLA Loneliness Scale (3rd edition) Social isolation (Lubben Social Network Scale 6-item short version: LNSN-6) Depression (Geriatric Depression Scale: GDS) Feelings of security with the sensor: anxiety and security with the sensor itself (quite secure, a little secure, not feeling particularly secure, a little secure, quite secure), and if anxious Expectations for the sensor: to be able to monitor sleep/ to be able to notice any changes quickly/ to monitor daily life/ don't know/ other Translated with www.DeepL.com/Translator (free version)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment

Intervention
No. of arms	3
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Intervention group A: Monthly sleep reports are sent by a sleep monitoring device and a professional (public health nurse/nurse) expertly interprets the sleep data and provides telephone intervention to the subject as soon as possible after sending the sleep report (6 months).
Interventions/Control_2	Intervention Group B: For the first 3 months, as in Intervention Group A, a sleep monitoring device will be used to send monthly sleep reports, and a professional (public health nurse/nurse) will interpret the sleep data professionally and provide telephone intervention to the subject as soon as possible after sending the sleep reports. In the following 3 months, the sleep monitoring device will only measure sleep and send sleep reports (3 months).
Interventions/Control_3	Intervention group C (control group): sleep measurement with sleep monitoring device and sending sleep reports only (6 months)
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	The subjects of this study must meet one of the following criteria at the start of the study Elderly people (aged 65 and over) living alone in the community People who "need support" according to long-term care insurance With the cooperation of the city of Sakai, we will invite applications from the public via the internet and posters
Key exclusion criteria	People who already seek regular specifically medical attention for sleep-related conditions
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Manabu Middle name Last name Ikeda
Organization	Osaka University
Division name	Department of Psychiatry, Graduate School of Medicine
Zip code	5650871
Address	2-2, Yamadaoka, Suita city
TEL	0668793050
Email	mikeda@psy.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Miyae Middle name Last name Yamakawa
Organization	Osaka University
Division name	Department of Geriatric Nursing, Graduate School of Medicine
Zip code	5650871
Address	1-7, Yamadaoka, Suita City
TEL	0668792543
Homepage URL
Email	miyatabu@sahs.med.osaka-u.ac.jp

Sponsor
Institute	OsakaUniversity
Institute
Department

Funding Source
Organization	NTT-PARAVITA
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka University Hospital Ethics Review Committee
Address	2-2, Yamadaoka, Suita City
Tel	0668795111
Email	rinri-jim@dmi.med.osaka-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

Other administrative information
Date of disclosure of the study information	2021 Year 12 Month 15 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	Preinitiation
Date of protocol fixation	2021 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date	2021 Year 12 Month 20 Day
Last follow-up date	2022 Year 09 Month 30 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 12 Month 15 Day
Last modified on	2021 Year 12 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052743