UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058308 |
|---|---|
| Receipt number | R000066636 |
| Scientific Title | Study on sleep blood pressure measured by a hoseless upper arm-type blood pressure monitoring device |
| Date of disclosure of the study information | 2025/07/01 |
| Last modified on | 2025/06/28 06:01:14 |
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Basic information
Public title
Study on sleep blood pressure measured by a hoseless upper arm-type blood pressure monitoring device
Acronym
Study on sleep blood pressure measured by a hoseless upper arm-type blood pressure monitoring device
Scientific Title
Study on sleep blood pressure measured by a hoseless upper arm-type blood pressure monitoring device
Scientific Title:Acronym
Study on sleep blood pressure measured by a hoseless upper arm-type blood pressure monitoring device
Region
| Japan |
Condition
Condition
Hypertension, sleep apnea syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the nighttime and sleep BP control status in individuals with various sleeping habits, using a hoseless upper arm-type blood pressure monitoring device, UA-1300BLE.
To investigate participants' feasibility and preference of BP monitoring during sleep using a nocturnal home BP monitoring device, UA-1300BLE.
Basic objectives2
Others
Basic objectives -Others
Comparison between nighttime BP and sleep BP
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison between nighttime BP average and sleep BP average
Key secondary outcomes
1) Nighttime BP and sleep BP control status by participants with each sleeping habit
2) Control status of evening BP and morning BP
3) Association between physical activity and blood pressure
4) Feasibility and preference of BP monitoring during sleep by the UA-1300BLE device
5) Exploring an algorithm to identify nighttime behaviors (including nocturia) from physical activity levels
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
All participants must meet the following criteria:
1) Upper arm circumference: 22.0 cm - 32.0 cm
2) Wrist circumference: 13.0 cm - 20.0 cm
3) A total of 100 participants shall be selected to meet the following participant composition conditions.
(Individuals who meet multiple criteria (1 through 5) may also be enrolled, and in such cases, they shall be counted toward the number of participants for each applicable criterion):
[Participant Composition Conditions]
1. At least 40 participants with hypertension
2. At least 15 participants who have been told by family or those around them that they snore loudly or heavily
3. At least 15 shift workers or individuals whose bedtime varies by more than 2 hours
4. At least 15 participants who urinate at night an average of 2 or more times per night
5. At least 15 participants whose bedtime is earlier than 9:00 PM
6. At least 15 participants who do not meet any of the above five conditions
Key exclusion criteria
Those unfamiliar with the operation of digital devices and applications
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kazuomi |
| Middle name | |
| Last name | Kario |
Organization
Jichi Medical University School of Medicine
Division name
Division of Cardiovascular, Medicine, Department of Medicine
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi, Japan
TEL
0285-58-7538
kkario@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Kazuomi |
| Middle name | |
| Last name | Kario |
Organization
Jichi Medical University School of Medicine
Division name
Division of Cardiovascular, Medicine, Department of Medicine
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi, Japan
TEL
0285-58-7538
Homepage URL
kkario@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
other
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
A&D Company, Limited
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jichi Medical University Hospital Bioethics Committee for Clinical Research
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi, Japan
Tel
0285-58-8933
rinri@jichi.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
自治医科大学附属病院（栃木県）/Jichi Medical University Hospital(Tochigi, Japan)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Participants will measure their blood pressure in the evening, nighttime (sleep), and morning for three consecutive days using an upper-arm home blood pressure monitoring device, UA-1300BLE.The study will examine the association between sleep habits and blood pressure control.
Management information
Registered date
| 2025 | Year | 06 | Month | 28 | Day |
Last modified on
| 2025 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066636
