UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055852 |
|---|---|
| Receipt number | R000063829 |
| Scientific Title | Exploration of clinical background factors that impair sleep quality in hospitalized patients with heart failure: Objective evaluation of sleep using wearable devices |
| Date of disclosure of the study information | 2024/10/17 |
| Last modified on | 2025/10/17 09:06:57 |
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Basic information
Public title
Exploration of clinical background factors that impair sleep quality in hospitalized patients with heart failure: Objective evaluation of sleep using wearable devices
Acronym
The relationship between the clinical background of heart failure and the quality of sleep- A cross-sectional study using wearable devices-
Scientific Title
Exploration of clinical background factors that impair sleep quality in hospitalized patients with heart failure: Objective evaluation of sleep using wearable devices
Scientific Title:Acronym
The relationship between the clinical background of heart failure and the quality of sleep- A cross-sectional study using wearable devices-
Region
| Japan |
Condition
Condition
heart failure
Classification by specialty
| Cardiology | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the actual state of sleep in patients with heart failure is clarified and the relationship between sleep quality and clinical background is evaluated. Specifically, we will analyse the sleep patterns of patients with heart failure and aim to identify the factors that affect sleep quality.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
sleep efficiency
Key secondary outcomes
1. Basic clinical information
Age, gender, BMI, heart failure severity (NYHA classification), presence or absence of hypertension, presence or absence of dyslipidaemia, presence or absence of diabetes, presence or absence of chronic kidney disease, presence or absence of respiratory disease, smoking habits, drinking habits, medication, blood test data, physical frailty, social frailty
2. Fitbit data
Sleep time, wake time, number of awakenings, time in bed, REM sleep time, light sleep time, deep sleep time, average number of steps, average distance, average heart rate per day, average respiratory rate per day, average oxygen saturation per day
3. PSQI score
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
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Fitbit
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Hospitalised patients with NYHA class II or III heart failure
2) Patients aged 18 years or over (regardless of gender)
3) Patients who can wear the Fitbit for three consecutive days during their hospital stay
4) Patients who have been given an explanation of the study and who can sign the independent clinical research consent form
Key exclusion criteria
1) If the patient is unable to wear the Fitbit (e.g. due to allergies or interference with medical devices)
2) If there is a significant decline in cognitive function, making data collection difficult
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Ishinuki |
Organization
Sapporo Medical University, Department of Health and Sciences
Division name
Department of Health and Sciences
Zip code
0608556
Address
W17, S1, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
0116112111
tomohiro-ishi@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Ishinuki |
Organization
Sapporo Medical University
Division name
Department of Health and Sciences
Zip code
0608556
Address
W17, S1, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
0116112111
Homepage URL
tomohiro-ishi@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Tomohiro Ishinuki
Funding Source
Organization
None
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
Sapporo Medical University Hospital Clinical Research Review Committee
Address
W16, S1, Chuo-ku, Sapporo, Hokkaido, Japan
Tel
0116112111
ji-rskk@sapmed.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
| 2024 | Year | 10 | Month | 17 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1) Fitting the Fitbit
After obtaining consent, the researcher will lend the Fitbit to the subject and begin fitting it. The researcher will explain how to use the Fitbit in writing and verbally when lending it.
2) Data collection
The subject will wear the Fitbit for three days. The device does not need to be recharged, but the researcher will explain that it should be done at a time other than bedtime if necessary.
3) Collection of the Fitbit and data
Four days after obtaining consent, the subject will complete the PSQI questionnaire and hand in their Fitbit to the researcher. The data in the Fitbit will be transferred to a dedicated smartphone after the researcher has collected the Fitbit.
4) Collection of basic clinical information
The subject's basic clinical information will be collected from the electronic medical record.
Management information
Registered date
| 2024 | Year | 10 | Month | 16 | Day |
Last modified on
| 2025 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063829
