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 | 2026/04/23 15:46:54 |
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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
Not listed
Publication of results
Unpublished
Result
URL related to results and publications
Not listed
Number of participants that the trial has enrolled
10
Results
In the 10 subjects (56.0 years), no significant changes were observed in SBP, DBP, or HR upon waking or before bedtime. The PSQI showed marked improvement in the change from intervention. In one case involving urinary dysfunction, the PSQI decreased to 5 points after the intervention, and SBP upon waking showed a downward trend. The number of nocturnal urination episodes decreased significantly following the intervention (p<0.01).
Results date posted
| 2026 | Year | 04 | Month | 23 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
The strict inclusion criteria for participants made it impossible to recruit a sufficient number of subjects. Since conditions changed such as the participants sleep returning to normal prior to the intervention, we were forced to limit our analysis to a single representative case.
Date of the first journal publication of results
Baseline Characteristics
From October 2022 to January 2023, we publicly recruited participants from among faculty and staff members outside the Department of Acupuncture and Moxibustion at Morinomiya University of Medical Sciences, as well as parents of students in that department, targeting 10 individuals who reported dissatisfaction with their sleep and had a history of hypertension. Inclusion criteria were a Pittsburgh Sleep Quality Index (PSQI) score of 6 or higher, systolic blood pressure (SBP) below 140 mmHg, and diastolic blood pressure (DBP) below 90 mmHg. No criteria were set for heart rate (HR). Participants who had been diagnosed with hypertension at a medical institution and were taking medication were not excluded. Additionally, because the study period was long-term, participants were required to maintain general lifestyle habits (such as reducing salt intake, limiting alcohol consumption, and engaging in moderate exercise) and to avoid changing their medication regimen as much as possible. Participants who had received a clear diagnosis of a sleep disorder at a medical institution and were taking sleep inductors or similar medications were excluded. Furthermore, during the initial consultation, participants were asked about their symptoms, and those deemed to require medical consultation for conditions such as sleep apnea syndrome, restless legs syndrome, or REM sleep behavior disorder were also excluded.
Participant flow
Participants were recruited after receiving a written explanation of the study's objectives and methods, the potential benefits and risks, the procedures for handling adverse events, and their right to freely participate in or withdraw from the study, and written informed consent was obtained. We explained that we would take appropriate measures should any adverse effects arise regarding the protection of personal information and agreed to promptly discontinue the study if any physical or mental harm occurred to an individual during the intervention. Two copies of the information sheet and consent form were prepared, with the researcher and the subject each retaining one copy.
Adverse events
It was not reported.
Outcome measures
Participants were provided with automatic blood pressure monitors and instructed to measure their SBP, DBP, and HR three times each before bed and upon waking every day, recording the results in a blood pressure diary. Participants were instructed to note any concerning symptoms in the remarks section of the diary; as a result, one participant reported waking up at night to urinate every night, and since the frequency of these episodes was recorded, this participant was included in the analysis (nocturnal urination frequency: Nocturnus urinae frequentia; hereinafter NUF). At weeks 2, 6, and 8 of the study, participants completed the PSQI regarding their sleep over the past two weeks.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2026 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059948
