UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050508 |
|---|---|
| Receipt number | R000057527 |
| Scientific Title | Shiatsu Therapeutic Approach to Subjective Sleep Problems in the Elderly: An Exploratory Study and Evaluation of Effect |
| Date of disclosure of the study information | 2023/03/07 |
| Last modified on | 2025/01/07 14:47:12 |
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Basic information
Public title
Shiatsu Therapeutic Approach to Subjective Sleep Problems in the Elderly: An Exploratory Study and Evaluation of Effect
Acronym
Shiatsu Therapy for Subjective Sleep Problems in the Elderly
Scientific Title
Shiatsu Therapeutic Approach to Subjective Sleep Problems in the Elderly: An Exploratory Study and Evaluation of Effect
Scientific Title:Acronym
Shiatsu Therapy for Subjective Sleep Problems in the Elderly
Region
| Japan |
Condition
Condition
Sleep Disorders
Sleep Difficulties
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Estimate the effectiveness of acupressure on Elderly people with sleep difficulties and their sleep
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Autonomic function delived by heart rate variability
Key secondary outcomes
Demographic data
Actigraphy
Blood pressure
IRLSSG (International Restless Legs Syndrome Study Group) rating scale
Epworth Sleepiness Scale
Pittsburgh sleep quality index
Profile of Mood Status
Short-Form 8 of Health Survey
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
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
| Maneuver |
Interventions/Control_1
Acupressure or sham-acupressure for one hour once a week was performed for four weeks in randomized-crossover manner. Washout period between acupressure and sham-acupressure was at least one month.
Interventions/Control_2
Acupressure or sham-acupressure for one hour once a week was performed for four weeks in randomized-crossover manner. Washout period between acupressure and sham-acupressure was at least one month.
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Persons 60 years of age or older with sleep difficulties
2) No obstacles to completing the questionnaires.
3) The person agrees to participate in the research.
Key exclusion criteria
1) Have a serious medical condition other than restless legs syndrome.
2)Receiving manual therapy within three months.
3) Withdrawal of the consents to the participation of this study.
4) Change of prescription which may affect the outcome during the study period.
5) Patients who were assessed that they should not to be indicated acupressure therapy.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hirokuni |
| Middle name | |
| Last name | Tagaya |
Organization
Kitasato University, School of Allied Health Science, Department of Health Science
Division name
Mental Health
Zip code
252-0329
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
TEL
+81-42-778-8031
tagaya@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Asami |
| Middle name | |
| Last name | Uosumi |
Organization
Kitasato University, Graduate School of Medical Science
Division name
Sleep Medicine
Zip code
252-0329
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
TEL
+81-42-778-8031
Homepage URL
rls.kenkyuu@gmail.com
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Tagaya Hirokuni
Funding Source
Organization
Kitasato University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
Tel
+81-42-778-9757
kenkyu@kitasato-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
北里大学(神奈川県)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
10
Results
Poster presentation at Annual Meeting of the Japanese Society of Sleep Research (2021).
acupressure and sham treatments significantly decreased heart rate and significantly increased parasympathetic activity . Although there was no significant difference two treatments, a post hoc test revealed that sympathetic activity was significantly reduced after acupressure in subjects who were aware of periodic limb movements at night.
Results date posted
| 2023 | Year | 03 | Month | 06 | Day |
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
Completed
Date of protocol fixation
| 2020 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Already submitted to Journal of Japanese Society of Oriental Physiotherapy:49(2).
Management information
Registered date
| 2023 | Year | 03 | Month | 06 | Day |
Last modified on
| 2025 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057527
