UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052535 |
|---|---|
| Receipt number | R000059948 |
| Scientific Title | Effects of moxibustion self-care on sleep disorders and hypertension |
| Date of disclosure of the study information | 2023/10/23 |
| Last modified on | 2025/04/21 14:35:58 |
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Basic information
Public title
Verification of whether insomnia and high blood pressure can be improved by using moxibustion before going to bed at home
Acronym
Moxibustion self-care for insomnia and hypertension
Scientific Title
Effects of moxibustion self-care on sleep disorders and hypertension
Scientific Title:Acronym
Effects of moxibustion self-care on sleep disorders and hypertension
Region
| Japan |
Condition
Condition
Sleep Disorders, hypertension
Classification by specialty
| Cardiology | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether moxibustion self-care for sleep disorders synchronously improves hypertension.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pittsburgh Sleep Quality Index
blood pressure
Key secondary outcomes
Actigraphy
Sleep onset latency
nocturnal awakening time
sleep efficiency
REM sleep time
OSA sleep inventory MA version
Nocturnal urination frequency
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Moxibustion treatment will be performed on 10 areas of the hands and feet before going to bed at least 3 days a week for 4 weeks.
Interventions/Control_2
No treatment
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who showed a score of 8 or higher on the Pittsburgh Sleep Inventory (PSQI).
Those who had systolic blood pressure less than 140 mmHg and diastolic blood pressure less than 90 mmHg.
Key exclusion criteria
Those who have received a clear diagnosis of sleep disorder at a medical institution and are taking medication.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | tomoyuki |
| Middle name | |
| Last name | Nabeta |
Organization
Morinomiya University of Medical Sciences, Faculty of Medical science Technology
Division name
Department of Acupuncture
Zip code
559-8611
Address
1-26-16 nankokita, Suminoe-ku, Osaka-shi, osaka 559-8611, jAPAN
TEL
+81-6-6616-6911
nabeta@morinomiya-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Nabeta |
Organization
Morinomiya University of Medical Sciences, Faculty of Medical science Technology
Division name
Department of Acupuncture
Zip code
559-8611
Address
1-26-16 nankokita, Suminoe-ku, Osaka-shi, osaka 559-8611, jAPAN
TEL
+81-6-6616-6911
Homepage URL
nabeta@morinomiya-u.ac.jp
Sponsor or person
Institute
Morinomiya University of Medical Sciences, Faculty of Medical science Technology, Department of Acupuncture
Institute
Department
Personal name
Funding Source
Organization
Morinomiya University of Medical Sciences, Faculty of Medical science Technology, Department of Acupuncture
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Morinomiya University of Medical Sciences
Address
1-26-16 nankokita, Suminoe-ku, Osaka-shi, osaka 559-8611, jAPAN
Tel
+81-6-6616-6911
nabeta@morinomiya-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
森ノ宮医療大学（大阪府）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 23 | 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
17
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
| 2023 | Year | 09 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 23 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2023 | Year | 10 | Month | 18 | Day |
Last modified on
| 2025 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059948
